HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
FDA 510(k) clearance K052172 · decided 2005-09-27
Clearance details
- K-number
- K052172
- Device name
- HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-09
- Decision date
- 2005-09-27
- Days to decision
- 49 days
- Clearance type
- Abbreviated
- 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 |
|---|---|---|
| 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 |
| Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. recall (Z-2254-2012) | Hitachi Medical Systems America Inc | 2012-08-23 |
| Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL recall (Z-0152-2007) | Hitachi Medical Systems America Inc | 2006-11-04 |