PHILIPS MODEL MX 16 SLICE CT SYSTEM
FDA 510(k) clearance K083498 · decided 2008-12-17
Clearance details
- K-number
- K083498
- Device name
- PHILIPS MODEL MX 16 SLICE CT SYSTEM
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-25
- Decision date
- 2008-12-17
- Days to decision
- 22 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
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a recall (Z-0190-2015) | Philips Medical Systems (Cleveland) Inc | 2014-12-16 |
| MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system. recall (Z-0019-2014) | Philips Medical Systems (Cleveland) Inc | 2013-10-17 |
| Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system. recall (Z-0899-2013) | Philips Medical Systems (Cleveland) Inc | 2013-02-28 |
| MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System recall (Z-2386-2012) | Philips Medical Systems (Cleveland) Inc | 2012-09-14 |
| MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E98 recall (Z-2059-2011) | Philips Medical Systems (Cleveland) Inc | 2011-04-26 |
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 |