Cleared Abbreviated

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

K162190 · Villa Sistemi Medicali S.P.A. · Radiology
Jul 2017
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K162190 is an FDA 510(k) clearance for the Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology), a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Villa Sistemi Medicali S.P.A. (Buccinasco, IT). The FDA issued a Cleared decision on July 6, 2017, 336 days after receiving the submission on August 4, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K162190 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2016
Decision Date July 06, 2017
Days to Decision 336 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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