JAK · System, X-Ray, Tomography, Computed
Radiology · 21 CFR 892.1750 · Class 2
Overview
| Product Code | JAK |
|---|---|
| Device Name | System, X-Ray, Tomography, Computed |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 817)
Showing 20 most recent of 817 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | Mar 27, 2026 | SESE |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | Mar 23, 2026 | SESE |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | Mar 23, 2026 | SESE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | Mar 20, 2026 | SESE |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | Mar 20, 2026 | SESE |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | Mar 13, 2026 | SESE |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | Mar 13, 2026 | SESE |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | Mar 6, 2026 | SESE |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | Mar 6, 2026 | SESE |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | Mar 5, 2026 | SESE |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | Jan 20, 2026 | SESE |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | Nov 28, 2025 | SESE |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | Oct 15, 2025 | SESE |
| K250662 | Bunkerhill MAC | BunkerHill Health | Oct 3, 2025 | SESE |
| K250766 | LungQ 4 | Thirona BV | Oct 2, 2025 | SESE |
| 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 | Sep 26, 2025 | SESE |
| K250928 | OmniTom Elite with PCD | Neurologica Corporation | Sep 8, 2025 | SESE |
| K251484 | CT:VQ | 4Dmedical Limited | Aug 28, 2025 | SESE |
| K250941 | Revolution Vibe | Ge Medical Systems, LLC | Aug 1, 2025 | SESE |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | Jul 28, 2025 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 105 clearances
- Toshiba America Medical Systems, In.C — 35 clearances
- General Electric Co. — 31 clearances
- Ge Medical Systems, LLC — 29 clearances
- Toshibamedical Systems Corporation — 27 clearances
