MAGNETIC RESONANCE DIAGNOSTIC DEVICE
FDA 510(k) clearance K072279 · decided 2007-09-21
Clearance details
- K-number
- K072279
- Device name
- MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-16
- Decision date
- 2007-09-21
- Days to decision
- 36 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 |
|---|---|---|
| Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR recall (Z-2366-2015) | Hitachi Medical Systems America Inc | 2015-08-10 |
| 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 Oasis Magnetic Resonance Scanners Software V1.0C The intended use: The MR system p recall (Z-1534-2010) | Hitachi Medical Systems America Inc | 2010-05-04 |