FDA 510(k)

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

K-Nummer: K162190 · 2017-07-06

AntragstellerVilla Sistemi Medicali S.P.A.

Entscheidungsdatum2017-07-06

ProduktcodeMUH

BeratungsausschussDE

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit Villa Sistemi Medicali S.P.A. als Antragsteller

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

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Offizielle Quelle

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