Spectral CT on Rails
FDA 510(k) clearance K212875 · decided 2022-05-13
Clearance details
- K-number
- K212875
- Device name
- Spectral CT on Rails
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-09
- Decision date
- 2022-05-13
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Spectral CT on Rails. Model Number: 728334. recall (Z-1825-2026) | PHILIPS MEDICAL SYSTEMS | 2026-04-16 |
| Spectral CT 7500 on Rails; Product Code (REF): 728334; recall (Z-1318-2026) | Philips North America Llc | 2026-02-06 |
| Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; recall (Z-1324-2025) | Philips Medical Systems Nederland B.V. | 2025-03-12 |
| Spectral CT on Rails: Software Version 5.1.0.X, model 728334. recall (Z-1054-2024) | PHILIPS MEDICAL SYSTEMS | 2024-02-08 |
| Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 recall (Z-0319-2024) | Philips North America | 2023-11-16 |
| Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 recall (Z-0306-2024) | Philips North America | 2023-11-15 |