HITACHI ALTAIRE
FDA 510(k) clearance K022390 · decided 2002-10-11
Clearance details
- K-number
- K022390
- Device name
- HITACHI ALTAIRE
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-23
- Decision date
- 2002-10-11
- Days to decision
- 80 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 |
|---|---|---|
| Hitachi Altaire Magnetic Resonance Imaging System recall (Z-1103-06) | Hitachi Medical Systems America Inc | 2006-06-10 |
| Magnetic Resonance Imaging Device recall (Z-0910-06) | Hitachi Medical Systems America Inc | 2006-05-31 |
| Hitachi Altaire Magnetic Resonance Imaging Device. recall (Z-0888-05) | Hitachi Medical Systems America Inc | 2005-06-14 |
| Altaire, Magnetic Resonance Imaging Device. recall (Z-0846-05) | Hitachi Medical Systems America Inc | 2005-05-17 |
| Altaire, Magnetic Resonance Imaging Device. recall (Z-0797-05) | Hitachi Medical Systems America Inc | 2005-05-03 |