PHILIPS GYROSCAN TN 15
FDA 510(k) clearance K932645 · decided 1993-12-13
Clearance details
- K-number
- K932645
- Device name
- PHILIPS GYROSCAN TN 15
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-02
- Decision date
- 1993-12-13
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 5680 Da Best, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gyroscan ACS-NT system recall (Z-1199-03) | Philips Medical Systems | 2003-09-12 |
| Gyroscan ACS-NT with software versions R6x, R7x, R8x recall (Z-1227-03) | Philips Medical Systems | 2003-09-12 |
| Gyroscan NT-Intera recall (Z-1228-03) | Philips Medical Systems | 2003-09-12 |
| Gyroscan Intera 1.0T & 1.5T recall (Z-1229-03) | Philips Medical Systems | 2003-09-12 |