JAK
- 产品代码
- JAK
- 器械名称
- System, X-Ray, Tomography, Computed
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1750
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 822 件
该代码近三年的 510(k)（81 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253450 | 2026-07-28 | NeuroLogica Corp., a Samsung Company | BodyTom Elite (NL4000) | |
| K253770 | 2026-07-21 | GE Medical Systems SCS | CardIQ Suite | |
| K253560 | 2026-06-24 | Ge Medical Systems, LLC | Enhanced Boundary for PCCT | |
| K253026 | 2026-06-04 | Varian Medical Systems, Inc. | Respiratory Gating for Scanners (2.1) | |
| K253596 | 2026-05-20 | Canon Medical Systems Corporation | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | |
| K253649 | 2026-03-27 | Philips Medical Systems Technologies , | Spectral CT Verida Family | |
| K252992 | 2026-03-23 | Philips Healthcare (Suzhou) Co., Ltd. | CT Rembra RT; CT Areta RT; CT Rembra | |
| K253686 | 2026-03-23 | Ge Healthcare Japan Corporation | True Definition DL | |
| K253574 | 2026-03-20 | Siemens Medical Solutions USA, Inc. | SOMATOM X.cite; SOMATOM X.ceed | |
| K253520 | 2026-03-20 | Ge Medical Systems, LLC | Photonova Spectra, Photonova Spectra Select | |
| K252249 | 2026-03-13 | Mars Bioimaging , Ltd. | Extremity CT Imaging System | |
| K260078 | 2026-03-13 | Canon Medical Systems Corporation | Aquilion ServeSP (TSX-307B) V2.0 | |
| K260166 | 2026-03-06 | BunkerHill Health | Bunkerhill Contrast CAC | |
| K260167 | 2026-03-06 | BunkerHill Health | Bunkerhill Contrast AVC | |
| K260169 | 2026-03-05 | Philips Medical Systems Nederland B.V. | AV Cardiac CT | |
| K253173 | 2026-01-20 | Shanghai United Imaging Healthcare Co. | uCT 780 with uWS-CT-Dual Energy Analysis | |
| K252217 | 2025-11-28 | Canon Medical Informatics, Inc. | CT VScore+ | |
| K251805 | 2025-10-15 | Siemens Medical Solutions USA, Inc. | syngo.CT Dual Energy | |
| K250662 | 2025-10-03 | BunkerHill Health | Bunkerhill MAC | |
| K250766 | 2025-10-02 | Thirona BV | LungQ 4 | |
| K251645 | 2025-09-26 | Canon Medical Systems Corporation | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix | |
| K250928 | 2025-09-08 | Neurologica Corporation | OmniTom Elite with PCD | |
| K251484 | 2025-08-28 | 4Dmedical Limited | CT:VQ | |
| K250941 | 2025-08-01 | Ge Medical Systems, LLC | Revolution Vibe | |
| K251061 | 2025-07-28 | Siemens Medical Solutions USA, Inc. | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; | |
| K250970 | 2025-07-25 | Leo Cancer Care | Marie | FDA |
| K250822 | 2025-07-03 | Siemens Medical Solutions USA, Inc. | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMAT | |
| K250648 | 2025-06-27 | Philips Medical Systems Nederland B.V. | Philips iCT CT system | |
| K243398 | 2025-06-20 | Canon Medical Systems Corporation | CT Scanner TSX-501R/1 V11.1 | |
| K243672 | 2025-06-18 | GE Medical Systems SCS | CardIQ Suite | |
| K250370 | 2025-05-20 | Fujifilm Corporation | SCENARIA View Phase 5.0 | |
| K243617 | 2025-05-16 | Shanghai United Imaging Healthcare Co. | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; | |
| K244008 | 2025-05-16 | Philips Medical Systems Technologies , | Spectral CT | |
| K250650 | 2025-04-15 | Arineta , Ltd. | SpotLight / SpotLight Duo with Low Dose Lung Cancer | |
| K243240 | 2025-04-10 | Canon Medical Informatics, Inc. | Vitrea CT VScore | |
| K242811 | 2025-03-14 | Neurologica Corporation, A Subsidiary | BodyTom 64 | |
| K242411 | 2025-02-19 | Brainomix Limited | Brainomix 360 e-Lung | |
| K243523 | 2025-02-12 | Siemens Medical Solutions USA, Inc. | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro | |
| K243229 | 2025-01-27 | BunkerHill Health | Bunkerhill AVC | |
| K241166 | 2025-01-14 | Shanghai United Imaging Healthcare Co. | uCT 550 | |
| K241200 | 2025-01-13 | Arineta , Ltd. | SpotLight/SpotLight Duo with Low Dose Lung Cancer Sc | |
| K241079 | 2025-01-07 | Shanghai United Imaging Healthcare Co. | uCT 780 | |
| K241757 | 2025-01-03 | Siemens Medical Solutions USA, Inc. | syngo.CT Dual Energy | |
| K242403 | 2024-12-23 | Canon Medical Systems Corporation | Aquilion ONE (TSX-308A/3) V1.5 | |
| K242188 | 2024-12-03 | Riverain Technologies, Inc. | ClearRead CT CAC | |
| K242874 | 2024-11-21 | Varian Medical Systems, Inc. | Gating Reflector Block | |
| K240844 | 2024-10-18 | Philips Medical Systems Technologies , | Spectral CT 7500 RT | |
| K240369 | 2024-09-27 | BunkerHill Health | CAC (gated) Algorithm | |
| K241295 | 2024-09-03 | Siemens Medical Solutions USA, Inc. | SOMATOM On.site | |
| K241440 | 2024-08-19 | Nano-X AI , Ltd. | HealthCCSng | |
| K233731 | 2024-08-01 | GE Medical Systems SCS | CardIQ Suite | FDA |
| K241713 | 2024-07-12 | Curvebeam, LLC | HiRise (1040-230) | |
| K233767 | 2024-06-10 | Neurologica Corporation | OmniTom Elite | |
| K233875 | 2024-05-13 | Brainomix Limited | Brainomix 360 e-Lung | |
| K232491 | 2024-05-03 | Philips Healthcare (Suzhou) Co., Ltd. | CT 5300 | |
| K233583 | 2024-04-26 | FUJIFILM Healthcare Americas Corporati | FCT iSTREAM Phase 1 | |
| K233698 | 2024-04-11 | Ge Healthcare Japan Corporation | True Enhance DL | |
| K232227 | 2024-04-04 | Neuwave Medical, Inc. | ABLATE-IQ | |
| K232835 | 2024-04-02 | Canon Medical Systems Corporation | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruct | |
| K233750 | 2024-04-02 | Ge Medical Systems, LLC | ECG-less Cardiac | FDA |
| K233657 | 2024-03-28 | Siemens Medical Solutions USA, Inc. | NAEOTOM Alpha | |
| K233650 | 2024-03-26 | Siemens Medical Solutions USA, Inc. | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMAT | FDA |
| K233753 | 2024-03-21 | Siemens Healthcare GmbH | AI-Rad Companion (Pulmonary) | |
| K232022 | 2024-03-13 | Cascination AG | CAS-One IR | |
| K233749 | 2024-02-22 | Ge Hangwei Medical Systems Co., Ltd. | Revolution Ascend Sliding | |
| K233080 | 2024-02-08 | Nano-X AI , Ltd. | HealthFLD | |
| K234030 | 2024-01-17 | Clear Guide Medical | Clear Guide SCENERGY | |
| K232412 | 2024-01-08 | Thirona BV | LungQ v3.0.0 | |
| K232136 | 2024-01-04 | Siemens Medical Solutions USA, Inc. | syngo.CT Applications | |
| K232206 | 2023-12-06 | Siemens Medical Solutions USA, Inc. | SOMATOM Pro.Pulse | |
| K233334 | 2023-12-06 | Canon Medical Systems Corporation | Aquilion Serve SP (TSX-307B/1) V1.3 | |
| K232155 | 2023-11-30 | Siemens Medical Solutions USA, Inc. | syngo.CT Dual Energy | |
| K231482 | 2023-11-29 | Shanghai United Imaging Healthcare Co. | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, | |
| K231631 | 2023-11-28 | Aidoc Medical , Ltd. | BriefCase-Quantification | |
| K232392 | 2023-11-16 | 4Dmedical Limited | CT Lung Ventilation Analysis Software (CT:V) | |
| K232045 | 2023-10-27 | MeVis Medical Solutions AG | MeVis Liver Suite | |
| K230370 | 2023-10-13 | Arineta , Ltd. | SpotLight/SpotLight Duo (with DLIR option) | |
| K231574 | 2023-10-12 | FUJIFILM Healthcare Americas Corporati | Scenaria View 4.2 | |
| K230220 | 2023-10-11 | Neusoft Medical Systems Co., Ltd. | NeuViz 128 Multi-Slice CT Scanner System | |
| K230130 | 2023-10-10 | Isys Medizintechnik GmbH | Micromate Navi+ | |
| K231281 | 2023-09-19 | Canon Medical Systems Corporation | Aquilion Serve (TSX-307A/1) V1.3 |
FDA 官方分类页： JAK
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。