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FDA 510(k)

ROTOGRAPH EVO 3D

K-Number: K111152 · 2011-07-22

ApplicantVilla Sistemi Medicali S.P.A.
Decision Date2011-07-22
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROTOGRAPH EVO 3D 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 2011-07-22 under 510(k) number K111152. 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 EVO 3D?

ROTOGRAPH EVO 3D is a medical device that received FDA 510(k) clearance on 2011-07-22. The listed applicant is Villa Sistemi Medicali S.P.A.. The 510(k) number is K111152.

When did ROTOGRAPH EVO 3D receive FDA 510(k) clearance?

ROTOGRAPH EVO 3D received FDA 510(k) clearance on 2011-07-22, under 510(k) number K111152.

Who is the listed applicant for ROTOGRAPH EVO 3D?

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 EVO 3D?

The FDA product code for ROTOGRAPH EVO 3D is MUH.

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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)K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)K130109ENDOGRAPH DCK090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191K080859DRF 4343K050190APOLLO

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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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