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FDA 510(k)

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

K-Number: K162190 · 2017-07-06

ApplicantVilla Sistemi Medicali S.P.A.
Decision Date2017-07-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) is a medical device manufactured by Villa Sistemi Medicali S.P.A.. It received FDA 510(k) clearance on 2017-07-06 under approval number K162190. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2017-07-06. It is manufactured by Villa Sistemi Medicali S.P.A.. The 510(k) number is K162190.

When was Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) approved by the FDA?

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) received FDA 510(k) clearance on 2017-07-06, under approval number K162190.

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

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) is manufactured by Villa Sistemi Medicali S.P.A..

What is the FDA product code for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)?

The FDA product code for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) is MUH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026)

Other Devices by Villa Sistemi Medicali S.P.A.

K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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