# K041834: Adr Plus Ssxi Imaging Device for X-Ray Systems Such as X-Caliber, X-Caliber CM, Ana-Bel and Ana-Bel CM

- Pathway: 510(k) (Traditional)
- Applicant: Takara Belmont USA, Inc.
- Decided: Dec 3, 2004 after 149 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K062529: Belmax CM Model X168 (2006), 0 descendants of its own

## Indications for use
The ADR Plus SSXI Imaging Device for X-ray systems such as X-CALIBER, X-CALIBER CM, ANA-BEL and ANA-BEL CM, a Solid State X-Ray Imaging Device is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended to replace conventional radiographic film for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K041834
Methodology: https://510kreport.com/methodology