GYROSCAN INTERA (R7.5)
FDA 510(k) clearance K001796 · decided 2000-09-06
Clearance details
- K-number
- K001796
- Device name
- GYROSCAN INTERA (R7.5)
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-14
- Decision date
- 2000-09-06
- Days to decision
- 84 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 |
|---|---|---|
| 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 |
| The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and recall (Z-0469-2011) | Philips Medical Systems North America Co. Phillips | 2010-11-26 |
| Intera MRI recall (Z-0982-2007) | Philips Medical Systems North America Co. Phillips | 2007-06-27 |
| NT Intera Magnetic Resonance Image System recall (Z-1488-04) | Philips Medical Systems Sales & Service Region No. America | 2004-09-29 |