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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 the device name listed in this FDA 510(k) record. The listed applicant is Villa Sistemi Medicali S.P.A.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) 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. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K162190.

When did Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) receive FDA 510(k) clearance?

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 510(k) number K162190.

Who is the listed applicant for Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)?

The FDA 510(k) record lists Villa Sistemi Medicali S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Villa Sistemi Medicali S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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