The following data is part of a premarket notification filed by Radco Data Ab with the FDA for Dentaleye 2 Dental Image Management System.
| Device ID | K012439 |
| 510k Number | K012439 |
| Device Name: | DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | RADCO DATA AB P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm RADCO DATA AB P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-31 |
| Decision Date | 2002-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350111570026 | K012439 | 000 |
| 07350111570019 | K012439 | 000 |