# K101435: Imix Panorad and Somarad

- Pathway: 510(k) (Traditional)
- Applicant: Imix Adr Finland OY
- Decided: Sep 15, 2010 after 117 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K981556 (1998). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073114: Imix Insight X-Ray Systems, Imix Adr Finland OY (2008) Summary page 1.
- K083645: Radstar Family, Models: Radstar 4343 & Variations, 5 Star Medical, Inc. (2009) Summary page 1.
- K070618: Dicompacs, Model 5, Oehm Und Rehbein GmbH (2007) Summary page 1.

## Most influential descendants
- K113855: Panorad, Panorad SL (2012), 0 descendants of its own

## Indications for use
IMYIX PanoRad and SomnaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)

Source page: https://510kreport.com/device/K101435
Methodology: https://510kreport.com/methodology