The following data is part of a premarket notification filed by Sedecal Usa, Inc. with the FDA for Optima Urs Universal Radiographic System.
| Device ID | K012546 |
| 510k Number | K012546 |
| Device Name: | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | SEDECAL USA, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SEDECAL USA, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-07 |
| Decision Date | 2001-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904125571 | K012546 | 000 |
| 05414904085714 | K012546 | 000 |
| 05414904085707 | K012546 | 000 |
| 08436046002500 | K012546 | 000 |