# K973035: Viola II Dental Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Medical Systems, Inc.
- Decided: Sep 24, 1997 after 41 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Viola II Dental Camera system is designed for use in the following applications: 1. To allow the clinician to provide the patient with accurate information 2. To allow the clinician to provide educational information to the patient as well as other clinical personnel 3. To provide documentation for patient records 4. To assist the clinician in the diagnosis of oral cancer and gum diseases 5. To provide documentation for insurance companies

Source page: https://510kreport.com/device/K973035
Methodology: https://510kreport.com/methodology