GEMINI GXL
FDA 510(k) clearance K051170 · decided 2005-05-23
Clearance details
- K-number
- K051170
- Device name
- GEMINI GXL
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-06
- Decision date
- 2005-05-23
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- 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
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 |