Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)— 510(k) K162190

Name: FDA 510(k) clearance K162190
Creator: U.S. Food and Drug Administration
Published: 2017-07-06

Substantially Equivalent

Villa Sistemi Medicali S.P.A.

FDA 510(k) clearance K162190 for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology), Substantially Equivalent on 2017-07-06. Applicant: Villa Sistemi Medicali S.P.A.. Device class: 2.

Clearance details

Applicant: Villa Sistemi Medicali S.P.A.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2016-08-04
Decision date: 2017-07-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buccinasco, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUH

view all

K251793 — SOTA Cloud Smart Sensor (1.5)2026-03-03
K252570 — EzSensor HD, EzSensor UHD2025-11-10
K250687 — Cocoon Solo (DX-7020s)2025-10-24
K251206 — Digital X-Ray DentiMax Pro Imaging System2025-09-24
K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph) +3 more2024-10-25

More clearances from Villa Sistemi Medicali S.P.A.

view all

K180601 — Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)2018-11-02
K130109 — ENDOGRAPH DC2013-08-01
K111152 — ROTOGRAPH EVO 3D2011-07-22
K090749 — ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY11912009-05-18
K080859 — DRF 43432008-06-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.