# K130443: I-Max Touch 3D

- Pathway: 510(k) (Abbreviated)
- Applicant: Owandy
- Decided: Jun 14, 2013 after 113 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K973598 (1997). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111152: Rotograph Evo 3D, Villa Sistemi Medicali S.P.A. (2011) Summary page 1.

## Most influential descendants
- K180601: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) (2018), 1 descendant of its own
- K201382: X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) (2020), 0 descendants of its own

## Recalls of this device
- Aug 5, 2015 · Class II · Z-0129-2016: It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

## Indications for use
1-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is an extra-oral source Xray system which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It also has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector; the examined volume image is reconstructed to be viewed on 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals

Source page: https://510kreport.com/device/K130443
Methodology: https://510kreport.com/methodology