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FDA 510(k)

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

K-Number: K180601 · 2018-11-02

ApplicantVilla Sistemi Medicali S.P.A.
Decision Date2018-11-02
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) is a medical device manufactured by Villa Sistemi Medicali S.P.A.. It received FDA 510(k) clearance on 2018-11-02 under approval number K180601. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)?

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Villa Sistemi Medicali S.P.A.. The 510(k) number is K180601.

When was Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) approved by the FDA?

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) received FDA 510(k) clearance on 2018-11-02, under approval number K180601.

What company makes Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)?

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) is manufactured by Villa Sistemi Medicali S.P.A..

What is the FDA product code for Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)?

The FDA product code for Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) is OAS.

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.

K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (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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