ECHELON OVAL MRI SYSTEM
FDA 510(k) clearance K113145 · decided 2012-05-01
Clearance details
- K-number
- K113145
- Device name
- ECHELON OVAL MRI SYSTEM
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-25
- Decision date
- 2012-05-01
- Days to decision
- 189 days
- Clearance type
- Traditional
- 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 Echelon Oval MRI System recall (Z-1541-2017) | Hitachi Medical Systems America Inc | 2017-03-23 |
| Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and recall (Z-2564-2014) | Hitachi Medical Systems America Inc | 2014-09-02 |
| Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, recall (Z-1559-2013) | Hitachi Medical Systems America Inc | 2013-06-19 |