# K113855: Panorad, Panorad SL

- Pathway: 510(k) (Special)
- Applicant: Imix Adr Finland OY
- Decided: Jan 25, 2012 after 27 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: 8 generations back to K981556 (1998). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101435: Imix Panorad and Somarad, Imix Adr Finland OY (2010) Summary page 1.
- K111583: Flaatz 560, Drtech Corp. (2011) Summary page 1.
- K080064: Flaatz 750, Drtech Corp. (2008) Summary page 1.
- K102349: Aerodr System, Konica Minolta Medical & Graphic, Inc. (2010) Summary page 1.
- K070618: Dicompacs, Model 5, Oehm Und Rehbein GmbH (2007) Summary page 1.

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

Source page: https://510kreport.com/device/K113855
Methodology: https://510kreport.com/methodology