# K083057: I-Max Touch

- Pathway: 510(k) (Traditional)
- Applicant: Owandy
- Decided: Jun 2, 2009 after 231 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
Longest line of descent: 3 generations back to K961826 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002432: Strato X, Villa Sistemi Medicali S.P.A. (2000) Summary page 1.
- K041120: EV Apan Digital, Model K1VSM2000, Afp Imaging Corp. (2004) Summary page 1.

## Indications for use
The I-Max Touch (PAN and Ceph) is a digital image acquisition system to be used in conjunction with a Villa Sistemi Medicali Digital Panoramic X-ray System, such as I-Max Plus or Strato D, to capture images by a sensor, digitalize the image, review images and format images to be sent to a PC, according to a standard protocol, through the existing acquisition board of panoramic system.

Source page: https://510kreport.com/device/K083057
Methodology: https://510kreport.com/methodology