ECHOSTAR SPICA 1.5T MR SYSTEM
FDA 510(k) clearance K113511 · decided 2012-05-02
Clearance details
- K-number
- K113511
- Device name
- ECHOSTAR SPICA 1.5T MR SYSTEM
- Applicant
- Alltech Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-28
- Decision date
- 2012-05-02
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Solon, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. recall (Z-1061-2015) | Alltech Medical Systems America Inc | 2015-02-18 |