MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
FDA 510(k) clearance K013722 · decided 2002-02-11
Clearance details
- K-number
- K013722
- Device name
- MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
- Applicant
- Hitachi Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-09
- Decision date
- 2002-02-11
- Days to decision
- 94 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- 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-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Ver recall (Z-2055-2009) | Hitachi Medical Systems America Inc | 2009-09-09 |