HITACHI AIRIS II
FDA 510(k) clearance K001334 · decided 2000-07-06
Clearance details
- K-number
- K001334
- Device name
- HITACHI AIRIS II
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-27
- Decision date
- 2000-07-06
- Days to decision
- 70 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 AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2E recall (Z-1616-2010) | Hitachi Medical Systems America Inc | 2010-05-19 |
| Hitachi AIRIS II MRI System recall (Z-1115-06) | Hitachi Medical Systems America Inc | 2006-06-14 |
| Hitachi AIRIS II Magnetic Resonance Imaging Device recall (Z-0889-05) | Hitachi Medical Systems America Inc | 2005-06-14 |