The following data is part of a premarket notification filed by Imaging Sciences International with the FDA for I-cat Flx V Series / Kavo 3d Exam+ V Series.
| Device ID | K162085 |
| 510k Number | K162085 |
| Device Name: | I-CAT FLX V Series / KaVo 3D EXam+ V Series |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | IMAGING SCIENCES INTERNATIONAL 1910 NORTH PENN RD. Hatfield, PA 19454 |
| Contact | Ruth Pui |
| Correspondent | Ruth Pui IMAGING SCIENCES INTERNATIONAL 1910 NORTH PENN RD. Hatfield, PA 19454 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV083083000 | K162085 | 000 |
| EKAV083082000 | K162085 | 000 |
| EKAV083081000 | K162085 | 000 |
| D090083083000 | K162085 | 000 |
| D090083082000 | K162085 | 000 |
| D090083081000 | K162085 | 000 |
| D090083065000 | K162085 | 000 |
| D090083063000 | K162085 | 000 |
| D090083060000 | K162085 | 000 |