I-CAT SCANNER
FDA 510(k) clearance K061284 · decided 2006-07-03
Clearance details
- K-number
- K061284
- Device name
- I-CAT SCANNER
- Applicant
- Imaging Sciences Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-08
- Decision date
- 2006-07-03
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hatfield, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufact recall (Z-1265-2009) | Imaging Sciences International, LLC | 2009-05-22 |
| i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private recall (Z-1646-2008) | Imaging Sciences Intl Inc | 2008-09-01 |