# K122260: Aycan Mobile

- Pathway: 510(k) (Traditional)
- Applicant: Aycan Digitalsysteme GmbH
- Decided: Sep 12, 2012 after 47 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K954874 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103785: Mobile Mim, Mim Software, Inc. (2011) Summary page 1.

## Indications for use
The aycan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only. aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. This device is not to be used for mammography.

Source page: https://510kreport.com/device/K122260
Methodology: https://510kreport.com/methodology