The following data is part of a premarket notification filed by Icrco Inc. with the FDA for Clarisct.
| Device ID | K120753 |
| 510k Number | K120753 |
| Device Name: | CLARISCT |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | ICRCO INC. 2580 WEST 237TH STREET Torrance, CA 90505 |
| Contact | Greg Wachtler |
| Correspondent | Greg Wachtler ICRCO INC. 2580 WEST 237TH STREET Torrance, CA 90505 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-13 |
| Decision Date | 2012-07-26 |