DVT SCANNER
FDA 510(k) clearance K051980 · decided 2005-08-19
Clearance details
- K-number
- K051980
- Device name
- DVT SCANNER
- Applicant
- Imaging Sciences Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-21
- Decision date
- 2005-08-19
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hatfield, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a th recall (Z-3018-2011) | Imaging Sciences International, LLC | 2011-08-12 |
| i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Ha recall (Z-0543-2010) | Imaging Sciences International, LLC | 2009-12-17 |
| i-CAT Classic 3D Dental Imaging System recall (Z-1645-2008) | Imaging Sciences Intl Inc | 2008-09-01 |