AIRIS
FDA 510(k) clearance K945155 · decided 1995-05-24
Clearance details
- K-number
- K945155
- Device name
- AIRIS
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-21
- Decision date
- 1995-05-24
- Days to decision
- 215 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 |
|---|---|---|
| MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. recall (Z-0029-2007) | Hitachi Medical Systems America Inc | 2006-10-12 |
| MRP-7000, AIRIS Magnetic Resonance Imaging Systems recall (Z-1105-06) | Hitachi Medical Systems America Inc | 2006-06-10 |
| The AIRIS MR System is an imaging device and is intended to provide the physician with phy recall (Z-0428-06) | Hitachi Medical Systems America Inc | 2006-01-24 |