# K162190: Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

- Pathway: 510(k) (Abbreviated)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Jul 6, 2017 after 336 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: 4 generations back to K961826 (1996). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191, Villa Sistemi Medicali S.P.A. (2009) Summary page 4.

## 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

## Indications for use
Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and oral structures. The devices are operated and used by dentists, radiologists and other legally qualified health care professionals. They can be used with both pediatric and adult patients.

Source page: https://510kreport.com/device/K162190
Methodology: https://510kreport.com/methodology