# K180601: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

- Pathway: 510(k) (Abbreviated)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Nov 2, 2018 after 240 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K973598 (1997). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130443: I-Max Touch 3D, Owandy (2013) Summary page 4.
- K162190: Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology), Villa Sistemi Medicali S.P.A. (2017) Summary page 5.

## Most influential descendants
- 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 3D and I-MAX 3D are extra-oral dental panoramic and CBCT (aka CBVT) X-ray units to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped x-ray beam technique; both of them are well known techniques. 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/K180601
Methodology: https://510kreport.com/methodology