The following data is part of a premarket notification filed by Carestream Dental Llc with the FDA for Cs Orthodontic Imaging Software Cs Oms Imaging Software.
| Device ID | K122427 |
| 510k Number | K122427 |
| Device Name: | CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | CARESTREAM DENTAL LLC 1765 THE EXCHANGE Atlanta, GA 30339 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer CARESTREAM DENTAL LLC 1765 THE EXCHANGE Atlanta, GA 30339 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-09 |
| Decision Date | 2012-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192156851666 | K122427 | 000 |
| 60192156851659 | K122427 | 000 |
| 60192156851642 | K122427 | 000 |
| 60192156851635 | K122427 | 000 |