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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 a medical device manufactured by De Götzen S.R.L.. It received FDA 510(k) clearance on 2021-02-05 under approval 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. It is manufactured by De Götzen S.R.L.. The 510(k) number is K203374.

When was X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) approved by the FDA?

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

What company makes 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 manufactured by De Götzen S.R.L..

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.

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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 De Götzen S.R.L.

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

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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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