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 |
|---|---|---|---|
| K260391 | AVIEW Aorta Metrics | Coreline Soft Co., Ltd. | 2026-10-16 |
| K261225 | CAS-One IR | Cascination AG | 2026-09-29 |
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | 2026-09-22 |
| K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | 2026-09-18 |
| K253836 | FCT iStream Phase 2 | Fujifilm Corporation | 2026-09-04 |
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| K253770 | CardIQ Suite | GE Medical Systems SCS | 2026-07-21 |
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026-06-24 |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026-06-04 |
| 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 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 |
| K260167 | Bunkerhill Contrast AVC | 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03760305400246 | DUAL SIDED NEEDLE GUIDE | QUANTUM SURGICAL | 2026-10-19 |
| 03760305400277 | PATIENT REFERENCE 2.0 | QUANTUM SURGICAL | 2026-10-19 |
| 00198953050996 | SnapShot Freeze | GE Medical Systems, L.L.C. | 2026-10-19 |
| 19356870000045 | CAC | 4DMEDICAL LIMITED | 2026-10-13 |
| 19356870000090 | LDA | 4DMEDICAL LIMITED | 2026-10-13 |
| 00860016243804 | C-beam | Pulmera, Inc. | 2026-10-10 |
| 00884838120433 | SmartCT | Philips Medical Systems Nederland B.V. | 2026-09-28 |
| 00850025268431 | Vitrea Advanced Visualization | Canon Medical Informatics, Inc. | 2026-09-21 |
| 00860015781925 | Bunkerhill Contrast AVC | Bunkerhill Health Inc. | 2026-09-16 |
| 00884838129559 | CT Areta RT/Rembra RT Upgrades | Philips Healthcare (Suzhou) Co., Ltd. | 2026-08-21 |
| 00860015781918 | iCAC Device | Bunkerhill Health Inc. | 2026-05-31 |
| 00860015781901 | CAC (Gated) Algorithm | Bunkerhill Health Inc. | 2026-05-13 |
| 00198953085950 | Photonova | GE Medical Systems, L.L.C. | 2026-05-11 |
| 00884838129542 | CT Areta RT | Philips Healthcare (Suzhou) Co., Ltd. | 2026-04-03 |
| 00884838129535 | CT Rembra RT | Philips Healthcare (Suzhou) Co., Ltd. | 2026-04-03 |
| 00884838129528 | CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-04-03 |
| 00195278940292 | Revolution | GE Hangwei Medical Systems Company Ltd. | 2025-02-28 |
| 00815686020101 | SPiN Thoracic Navigation System, 120V, 60Hz | VERAN MEDICAL TECHNOLOGIES INC. | 2016-11-16 |
| 00815686020118 | SPiN Thoracic Navigation System, 230V, 50Hz | VERAN MEDICAL TECHNOLOGIES INC. | 2016-11-16 |
| 00815686020064 | ig4 System V2, 120V, 60Hz | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020071 | ig4 System V2, 230V, 50Hz | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020088 | ig4 System, 120V, 60Hz | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020095 | ig4 System, 230V, 50Hz | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020231 | 17ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020248 | 17ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020255 | 17ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020262 | 18ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020279 | 18ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020286 | 18ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |
| 00815686020293 | 19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point | VERAN MEDICAL TECHNOLOGIES INC. | 2016-08-31 |