ECHELON Oval V 5.1 MRI System
FDA 510(k) clearance K153547 · decided 2016-03-31
Clearance details
- K-number
- K153547
- Device name
- ECHELON Oval V 5.1 MRI System
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-11
- Decision date
- 2016-03-31
- Days to decision
- 111 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Twinsburg, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hitachi Oasis MRI System recall (Z-1540-2017) | Hitachi Medical Systems America Inc | 2017-03-23 |
| Hitachi Echelon Oval MRI System recall (Z-1541-2017) | Hitachi Medical Systems America Inc | 2017-03-23 |