Philips iCT CT System
FDA 510(k) clearance K162838 · decided 2017-04-07
Clearance details
- K-number
- K162838
- Device name
- Philips iCT CT System
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-11
- Decision date
- 2017-04-07
- Days to decision
- 178 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. Brilliance iCT, Model Number: 728306. recall (Z-2598-2025) | Philips North America Llc | 2025-09-19 |
| iCT, Model # 728306, computed tomography x-ray system recall (Z-2189-2019) | Philips Medical Systems (Cleveland) Inc | 2019-08-06 |
| iCT SP Model # 728311, computed tomography x-ray system recall (Z-2190-2019) | Philips Medical Systems (Cleveland) Inc | 2019-08-06 |
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 |