MSK EXTREME MR SCANNER, MODEL AA5000
FDA 510(k) clearance K080048 · decided 2008-02-06
Clearance details
- K-number
- K080048
- Device name
- MSK EXTREME MR SCANNER, MODEL AA5000
- Applicant
- Oni Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-08
- Decision date
- 2008-02-06
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wilmington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MSK 1.5T Extreme MR Scanner, a diagnostic imaging device recall (Z-1927-2016) | GE Healthcare, LLC | 2016-06-08 |
| MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device t recall (Z-1211-2013) | GE Healthcare, LLC | 2013-05-01 |
| GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner is recall (Z-0107-2012) | GE Healthcare, LLC | 2011-10-26 |