The following data is part of a premarket notification filed by Soredex Palodex Group Oy with the FDA for Digora Optime (or Digora Ontime).
| Device ID | K041050 |
| 510k Number | K041050 |
| Device Name: | DIGORA OPTIME (OR DIGORA ONTIME) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SOREDEX PALODEX GROUP OY ELIMAENKATU 22 B Helsinki, FI |
| Contact | Kai Laner |
| Correspondent | Kai Laner SOREDEX PALODEX GROUP OY ELIMAENKATU 22 B Helsinki, FI |
| Product Code | MUH |
| Subsequent Product Code | EHD |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-22 |
| Decision Date | 2004-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872503 | K041050 | 000 |
| 06430035872497 | K041050 | 000 |
| 06430035872473 | K041050 | 000 |