JAK — System, X-Ray, Tomography, Computed Class II
FDA product code JAK covers "System, X-Ray, Tomography, Computed", a Class II medical device regulated under 21 CFR 892.1750. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JAK
- Device Class
- Class II
- Regulation Number
- 892.1750
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253560 | ge medical systems | Enhanced Boundary for PCCT | June 24, 2026 |
| K253026 | varian medical systems | Respiratory Gating for Scanners (2.1) | June 4, 2026 |
| K253596 | canon medical systems corporation | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | May 20, 2026 |
| K253649 | philips medical systems technologies | Spectral CT Verida Family | March 27, 2026 |
| K253686 | ge healthcare japan corporation | True Definition DL | March 23, 2026 |
| K252992 | philips healthcare (suzhou) co | CT Rembra RT; CT Areta RT; CT Rembra | March 23, 2026 |
| K253574 | siemens medical solutions usa | SOMATOM X.cite; SOMATOM X.ceed | March 20, 2026 |
| K253520 | ge medical systems | Photonova Spectra, Photonova Spectra Select | March 20, 2026 |
| K252249 | mars bioimaging | Extremity CT Imaging System | March 13, 2026 |
| K260078 | canon medical systems corporation | Aquilion ServeSP (TSX-307B) V2.0 | March 13, 2026 |
| K260166 | bunkerhill health | Bunkerhill Contrast CAC | March 6, 2026 |
| K260167 | bunkerhill health | Bunkerhill Contrast AVC | March 6, 2026 |
| K260169 | philips medical systems nederland | AV Cardiac CT | March 5, 2026 |
| K253173 | shanghai united imaging healthcare co | uCT 780 with uWS-CT-Dual Energy Analysis | January 20, 2026 |
| K252217 | canon medical informatics | CT VScore+ | November 28, 2025 |
| K251805 | siemens medical solutions usa | syngo.CT Dual Energy | October 15, 2025 |
| K250662 | bunkerhill health | Bunkerhill MAC | October 3, 2025 |
| K250766 | thirona | LungQ 4 | October 2, 2025 |
| K251645 | canon medical systems corporation | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S | September 26, 2025 |
| K250928 | neurologica corporation | OmniTom Elite with PCD | September 8, 2025 |