510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162190Substantially Equivalent

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

Villa Sistemi Medicali S.p.A., Buccinasco, IT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162190 is the FDA 510(k) clearance record for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology), a class II device, cleared for Villa Sistemi Medicali S.P.A. on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list 13 510(k) clearances for Villa Sistemi Medicali S.P.A., from to . As of , FDA records show no recalls naming K162190.

Clearance record

Decision date
Received
(336 days to decision)
Product code
MUH System, X-Ray, Extraoral Source, Digital
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Villa Sistemi Medicali S.P.A. Via Delle Azalee 3, Buccinasco, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MUH

Trailing 12 months
2 clearances under product code MUH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260