HITACHI PRESTO
FDA 510(k) clearance K040902 · decided 2004-04-21
Clearance details
- K-number
- K040902
- Device name
- HITACHI PRESTO
- Applicant
- Hitachi Medical Systems America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-07
- Decision date
- 2004-04-21
- Days to decision
- 14 days
- Clearance type
- Abbreviated
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Twinsburg, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. recall (Z-1651-2009) | Hitachi Medical Systems America Inc | 2009-07-07 |
| Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that pro recall (Z-0608-2009) | Hitachi Medical Systems America Inc | 2009-01-08 |
| Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) recall (Z-1078-06) | Hitachi Medical Systems America Inc | 2006-06-03 |
| Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT) recall (Z-1079-06) | Hitachi Medical Systems America Inc | 2006-06-03 |