# K073114: Imix Insight X-Ray Systems

- Pathway: 510(k) (Special)
- Applicant: Imix Adr Finland OY
- Decided: Jan 17, 2008 after 73 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: 6 generations back to K981556 (1998). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974863: Imix Digital Thorax System, Advanced Instrument Development, Inc. (1998) Summary page 1.
- K042876: Urs LP Digital, Millennium, Radpro, Sedecal., Sa. (2004) Summary page 1.
- K071193: Vidar Vision 3000 and 4000 X-Ray Systems, Vidar Systems Corp. (2007) Summary page 1.

## Most influential descendants
- K101435: Imix Panorad and Somarad (2010), 1 descendant of its own
- K113855: Panorad, Panorad SL (2012), 0 descendants of its own

## Indications for use
IMIX Insight 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. IMIX Insight X-Ray Systems is not indicated for diagnostic X-ray mammography.

Source page: https://510kreport.com/device/K073114
Methodology: https://510kreport.com/methodology