The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Orthopantomograph Op 3d.
| Device ID | K180947 |
| 510k Number | K180947 |
| Device Name: | Orthopantomograph OP 3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PaloDEx Group Oy Nahkelantie 160 Tuusula, FI 04300 |
| Contact | Terho Turkumaki |
| Correspondent | Terho Turkumaki PaloDEx Group Oy Nahkelantie 160 Tuusula, FI 04300 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-11 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872879 | K180947 | 000 |
| 06430035874484 | K180947 | 000 |
| 06430035874354 | K180947 | 000 |
| 06430035873517 | K180947 | 000 |
| 06430035873401 | K180947 | 000 |
| 06430035873425 | K180947 | 000 |
| 06430035873432 | K180947 | 000 |
| 06430035873449 | K180947 | 000 |
| 06430035873456 | K180947 | 000 |
| 06430035873463 | K180947 | 000 |
| 06430035873470 | K180947 | 000 |
| 06430035873487 | K180947 | 000 |
| 06430035873494 | K180947 | 000 |
| 06430035873500 | K180947 | 000 |
| 06430035872886 | K180947 | 000 |
| 06430035872862 | K180947 | 000 |
| 06430035873630 | K180947 | 000 |