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FDA 510(k)

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

K-Number: K203374 · 2021-02-05

ApplicantDe Götzen S.R.L.
Decision Date2021-02-05
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is the device name listed in this FDA 510(k) record. The listed applicant is De Götzen S.R.L.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203374. 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 X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is De Götzen S.R.L.. The 510(k) number is K203374.

When did X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) receive FDA 510(k) clearance?

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203374.

Who is the listed applicant for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

The FDA 510(k) record lists De Götzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

The FDA product code for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is MUH.

Other records listing De Götzen S.R.L. 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.

K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)

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Official Source

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

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