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 |
|---|---|---|---|
| K261229 | Fujifilm Corporation | SCENARIA View Phase 6.0 | Sep 18, 2026 |
| K253836 | Fujifilm Corporation | FCT iStream Phase 2 | Sep 4, 2026 |
| K253450 | Neurologica Corp., A Samsung | BodyTom Elite (NL4000) | Jul 28, 2026 |
| K253770 | Ge Medical Systems Scs | CardIQ Suite | Jul 21, 2026 |
| K253560 | Ge Medical Systems | Enhanced Boundary for PCCT | Jun 24, 2026 |
| K253026 | Varian Medical Systems | Respiratory Gating for Scanners (2.1) | Jun 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 | Mar 27, 2026 |
| K252992 | Philips Healthcare (Suzhou) Co | CT Rembra RT; CT Areta RT; CT Rembra | Mar 23, 2026 |
| K253686 | Ge Healthcare Japan Corporation | True Definition DL | Mar 23, 2026 |
| K253574 | Siemens Medical Solutions Usa | SOMATOM X.cite; SOMATOM X.ceed | Mar 20, 2026 |
| K253520 | Ge Medical Systems | Photonova Spectra, Photonova Spectra Select | Mar 20, 2026 |
| K260078 | Canon Medical Systems Corporation | Aquilion ServeSP (TSX-307B) V2.0 | Mar 13, 2026 |
| K252249 | Mars Bioimaging | Extremity CT Imaging System | Mar 13, 2026 |
| K260166 | Bunkerhill Health | Bunkerhill Contrast CAC | Mar 6, 2026 |
| K260167 | Bunkerhill Health | Bunkerhill Contrast AVC | Mar 6, 2026 |
| K260169 | Philips Medical Systems Nederland | AV Cardiac CT | Mar 5, 2026 |
| K253173 | Shanghai United Imaging Healthcare Co | uCT 780 with uWS-CT-Dual Energy Analysis | Jan 20, 2026 |
| K252217 | Canon Medical Informatics | CT VScore+ | Nov 28, 2025 |
| K251805 | Siemens Medical Solutions Usa | syngo.CT Dual Energy | Oct 15, 2025 |