GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
FDA 510(k) clearance K945945 · decided 1995-12-22
Clearance details
- K-number
- K945945
- Device name
- GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-05
- Decision date
- 1995-12-22
- Days to decision
- 382 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce recall (Z-1438-2018) | Philips Electronics North America Corporation | 2018-04-18 |
| ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produc recall (Z-1439-2018) | Philips Electronics North America Corporation | 2018-04-18 |
| T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produc recall (Z-1440-2018) | Philips Electronics North America Corporation | 2018-04-18 |
| SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T recall (Z-1024-2016) | Philips Electronics North America Corporation | 2016-02-26 |
| Gyroscan MRI recall (Z-0981-2007) | Philips Medical Systems North America Co. Phillips | 2007-06-27 |