Philips CT Big Bore
FDA 510(k) clearance K171850 · decided 2017-11-09
Clearance details
- K-number
- K171850
- Device name
- Philips CT Big Bore
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-21
- Decision date
- 2017-11-09
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Bril recall (Z-2597-2025) | Philips North America Llc | 2025-09-19 |
| Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray Sy recall (Z-1660-2025) | Philips North America Llc | 2025-04-23 |
| Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator des recall (Z-0292-2024) | Philips North America Llc | 2023-11-14 |
| Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simu recall (Z-0293-2024) | Philips North America Llc | 2023-11-14 |
| Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner recall (Z-0294-2024) | Philips North America Llc | 2023-11-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019) | Philips Medical Systems (Cleveland), Inc. | 1988-07-27 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018) | Philips Medical Systems (Cleveland), Inc. | 1988-06-13 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S016) | Philips Medical Systems (Cleveland), Inc. | 1988-04-28 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S014) | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |