The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Viola Ii Dental Camera System.
| Device ID | K973035 |
| 510k Number | K973035 |
| Device Name: | VIOLA II DENTAL CAMERA SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974 |
| Contact | Kevin T Spurgeon |
| Correspondent | Kevin T Spurgeon INNOVATIVE MEDICAL SYSTEMS, INC. 55 STEAM WHISTLE DR. Ivyland, PA 18974 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-14 |
| Decision Date | 1997-09-24 |