MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
FDA 510(k) clearance K013723 · decided 2002-02-06
Clearance details
- K-number
- K013723
- Device name
- MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
- Applicant
- Hitachi Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-09
- Decision date
- 2002-02-06
- Days to decision
- 89 days
- Clearance type
- Special
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Ver recall (Z-2054-2009) | Hitachi Medical Systems America Inc | 2009-09-09 |
| Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Ve recall (Z-1005-04) | Hitachi Medical Systems America Inc | 2004-07-20 |