# K042372: HDS Intra-Oral Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Vatech Value Added Technology Co., Ltd.
- Decided: Oct 4, 2004 after 34 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: 1 generation back to K021718 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021718: Intraoral Imaging System, Model Suni-Ray, Suni Imaging Microsystems, Inc. (2002) Summary page 1.

## Indications for use
"HDS" Intra-oral Imaging System is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

Source page: https://510kreport.com/device/K042372
Methodology: https://510kreport.com/methodology