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System, Tomography, Computed, Emission（KPS）
エミッションCT装置 この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
443 件
直近 2026.01.28
473 件
0 件
1,051 件
分類情報
| Product Code | KPS |
|---|---|
| デバイス名 | System, Tomography, Computed, Emission エミッションCT装置 この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス II |
| 21 CFR 規制番号 | 892.1200 |
| 審査区分 | 510(k)（市販前届出） |
| 医療専門分野 | 放射線科 |
| 定義 | － |
| フラグ | 該当なし |
| AI分析 | このシステムは、体内に投与した放射性医薬品から放出される放射線を検出し、断層画像として再構成する装置です。米国ではクラスIIに分類されており、市販前届出（510(k)）により、既存の同等な機器との実質的同等性を示すことで市場に出すことが認められています。21 CFR 892.1200 に規定される放射線科領域の医療機器です。 米国市場での動向 本製品コードは510(k)による審査品目であり、累計届出件数は約470件、参入企業数は約130社、直近5年間では約50件の届出が確認されています。不具合報告は累計約1,050件で、死亡8件、傷害164件に対し不具合（Malfunction）が643件と大半を占めており、主な問題としてMechanical Problem、Improper or Incorrect Procedure or Method、Fail-Safe Problemが挙げられています。回収は累計約440件で、クラスIが24件、クラスIIが約300件、クラスIIIが1件含まれ、直近5年間では約50件、最新の回収は2025年12月に開始されています。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
関連 product code
同じ 21 CFR 892.1200 に分類される product code（2 件）
類似の国内医療機器（自動推定）
FDA デバイス分類と JMDN 英語名の名称・定義文の類似度から機械的に推定した候補です。日米の当局が定めた公的な対応関係ではなく、参考情報としてご覧ください。
| No. | 類別 | 一般的名称 | 品目数 | 企業数 | 年間総出荷額 | 成長率 | 平均価格 | 国産比率 |
|---|---|---|---|---|---|---|---|---|
| 1 | 内臓機能検査用器具 | X線CT診断装置キセノンガス管理システムクラスⅡ | 2 | 1 | — | — | — | — |
| 2 | 医療用エックス線装置及び医療用エックス線装置用エックス線管 | 全身用X線CT診断装置クラスⅡ | 101 | 17 | 835.2 億円/年 | -6.3% | 3,378.22 万円/個 | 85.5% |
| 3 | 医療用エックス線装置及び医療用エックス線装置用エックス線管 | 人体回転型全身用X線CT診断装置クラスⅡ | — | — | — | — | — | — |
| 4 | 医療用エックス線装置及び医療用エックス線装置用エックス線管 | 部位限定X線CT診断装置クラスⅡ | 1 | 1 | — | — | — | — |
| 5 | 放射性物質診療用器具 | 核医学診断用ポジトロンCT装置クラスⅡ | 12 | 7 | — | — | — | — |
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 443 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-1112-2026 KPS | クラス II | 2025.12.24 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation). | 対応中 |
| Z-1047-2026 KPS | クラス II | 2025.12.10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. | 対応中 |
| Z-1045-2026 KPS | クラス II | 2025.12.10 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems. | 対応中 |
| Z-0303-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0302-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0301-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0300-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0299-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0298-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0297-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0296-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0295-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0294-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0293-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0292-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0291-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-0290-2026 KPS | クラス II | 2025.09.12 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
| Z-2098-2025 KPS | クラス II | 2025.06.20 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury. | 対応中 |
| Z-2097-2025 KPS | クラス II | 2025.06.20 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury. | 対応中 |
| Z-0900-2025 KPS | クラス II | 2024.12.18 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. | 対応中 |
510(k)（市販前届出）
全 473 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K261305 | MICSI-PET | Microstructure Imaging, Inc. | 2026.09.11 | 通常（Traditional） | |
| 2 | K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | 2026.07.28 | 通常（Traditional） | |
| 3 | K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. | 2026.05.21 | 特別（Special） | |
| 4 | K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | 2026.04.03 | 通常（Traditional） | |
| 5 | K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | 2026.02.13 | 通常（Traditional） | |
| 6 | K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | 2026.01.13 | 特別（Special） | |
| 7 | K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | 2025.12.30 | 通常（Traditional） | |
| 8 | K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | 2025.12.01 | 通常（Traditional） | |
| 9 | K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | 2025.11.25 | 通常（Traditional） | |
| 10 | K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | 2025.09.09 | 特別（Special） | |
| 11 | K250170 | PHAROS | Brightonix Imaging | 2025.08.15 | 通常（Traditional） | |
| 12 | K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | 2025.07.31 | 特別（Special） | |
| 13 | K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2025.07.17 | 通常（Traditional） | |
| 14 | K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | 2025.07.03 | 特別（Special） | |
| 15 | K251153 | Aurora | Ge Medical Systems Israel | 2025.06.12 | 通常（Traditional） | |
| 16 | K243881 | HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 | Bracco Diagnostics, Inc. | 2025.03.03 | 通常（Traditional） | |
| 17 | K241266 | Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. | 2025.01.27 | 通常（Traditional） | |
| 18 | K243605 | Aurora | Ge Medical Systems Israel, Functional Imaging | 2025.01.17 | 通常（Traditional） | |
| 19 | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2024.12.12 | 特別（Special） | |
| 20 | K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | 2024.11.08 | 通常（Traditional） |
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
この product code の PMA 情報はありません。
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。