Product code JAK
- Device name
- System, X-Ray, Tomography, Computed
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1750
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026-05-20 |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | 2025-11-28 |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-10-15 |
| K250662 | Bunkerhill MAC | BunkerHill Health | 2025-10-03 |
| K250766 | LungQ 4 | Thirona BV | 2025-10-02 |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation | 2025-09-26 |
| K250928 | OmniTom Elite with PCD | Neurologica Corporation | 2025-09-08 |
| K251484 | CT:VQ | 4Dmedical Limited | 2025-08-28 |
| K250941 | Revolution Vibe | Ge Medical Systems, LLC | 2025-08-01 |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | 2025-07-28 |
| K250970 | Marie | Leo Cancer Care | 2025-07-25 |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| K250648 | Philips iCT CT system | Philips Medical Systems Nederland B.V. | 2025-06-27 |
| K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | 2025-06-20 |
| K243672 | CardIQ Suite | GE Medical Systems SCS | 2025-06-18 |
| K250370 | SCENARIA View Phase 5.0 | Fujifilm Corporation | 2025-05-20 |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 |
| K244008 | Spectral CT | Philips Medical Systems Technologies , Ltd. | 2025-05-16 |
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. | 2025-04-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10810068810940 | MONARCH™ Advanced Imaging Accessory Kit | Auris Health, Inc. | 2026-06-02 |
| 00860015781918 | iCAC Device | Bunkerhill Health Inc. | 2026-05-31 |
| 10884521785977 | superDimension | Covidien LP | 2026-05-29 |
| 10884521851184 | superDimension | Covidien LP | 2026-05-29 |
| 10810068810841 | MONARCH™ Navigation Sensors | Auris Health, Inc. | 2026-05-27 |
| 10810068810858 | MONARCH™ Controller | Auris Health, Inc. | 2026-05-27 |
| 08719326703824 | LungQ® | Thirona B.V. | 2026-02-12 |
| 08800025300299 | AVIEW | CORELINE SOFT CO.,LTD. | 2025-03-27 |
| 08800025300367 | AVIEW CAC | CORELINE SOFT CO.,LTD. | 2025-03-24 |
| 10810068810582 | Monarch™ Tower Software v4.1.0 | Auris Health, Inc. | 2025-03-03 |
| 10810068810599 | Monarch™ Cart Software v4.1.0 | Auris Health, Inc. | 2025-03-03 |
| 04987670105579 | Aquilion ONE | CANON INC. | 2025-01-09 |
| 07640167220021 | CAS-One IR Consumable Set General | CAScination AG | 2024-06-17 |
| 10810068810803 | Monarch Bronchscope 2.0/Monarch Platform (P2) | Auris Health, Inc. | 2024-05-05 |
| 08800025300237 | AVIEW CAC | CORELINE SOFT CO.,LTD. | 2024-04-25 |
| 10810068810766 | Monarch™ Software Tower v2.2.5 | Auris Health, Inc. | 2024-02-16 |
| 10810068810773 | Monarch™ Software Cart v2.2.5 | Auris Health, Inc. | 2024-02-16 |
| 10810068810483 | Monarch™ Software Cart v2.2.4 | Auris Health, Inc. | 2023-02-03 |
| 10810068810476 | Monarch™ Software Tower v2.2.4 | Auris Health, Inc. | 2023-02-03 |
| 08800025300152 | AVIEW | CORELINE SOFT CO.,LTD. | 2023-01-09 |
| 09120105730464 | KOALA | IB Lab GmbH | 2022-01-11 |
| 04987670103797 | CT SCANNER | CANON INC. | 2021-11-01 |
| 08800025300077 | AVIEW | CORELINE SOFT CO.,LTD. | 2021-08-09 |
| 08800025300084 | AVIEW LCS | CORELINE SOFT CO.,LTD. | 2021-08-09 |
| 08800025300039 | AVIEW LCS | CORELINE SOFT CO.,LTD. | 2021-08-09 |
| 09120105730037 | KOALA | IB Lab GmbH | 2020-11-03 |
| 08033837931362 | NewTom | CEFLA SOCIETA' COOPERATIVA | 2017-05-31 |
| 00869346000200 | Airo® | MOBIUS IMAGING, LLC | 2016-09-30 |
| 04056869009179 | Multitom Rax | Siemens Healthcare GmbH | 2016-09-24 |
| EZIEZIEHMVISIONRFD3D1 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2016-09-23 |