# K181358: Televere Digital Dental Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Televere Systems, Inc.
- Decided: Jun 20, 2018 after 29 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K933455 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162619: I View and Imagen Sensor, Trident S.R.L (2016) Summary page 4.

## Indications for use
The Televere Digital Dental Imaging System is intended for radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.. Not for mammography. Not for fluoroscopy.

Source page: https://510kreport.com/device/K181358
Methodology: https://510kreport.com/methodology