JAK — System, X-Ray, Tomography, Computed Class II
FDA Device Classification
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 |
|---|
| K260078 | canon medical systems corporation | Aquilion ServeSP (TSX-307B) V2.0 | March 13, 2026 |
| K252249 | mars bioimaging | Extremity CT Imaging System | March 13, 2026 |
| K260167 | bunkerhill health | Bunkerhill Contrast AVC | March 6, 2026 |
| K260166 | bunkerhill health | Bunkerhill Contrast CAC | 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 |
| K251484 | 4dmedical limited | CT:VQ | August 28, 2025 |
| K250941 | ge medical systems | Revolution Vibe | August 1, 2025 |
| K251061 | siemens medical solutions usa | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | July 28, 2025 |
| K250970 | leo cancer care | Marie | July 25, 2025 |
| K250822 | siemens medical solutions usa | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; S | July 3, 2025 |
| K250648 | philips medical systems nederland | Philips iCT CT system | June 27, 2025 |
| K243398 | canon medical systems corporation | CT Scanner TSX-501R/1 V11.1 | June 20, 2025 |
| K243672 | ge medical systems scs | CardIQ Suite | June 18, 2025 |