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FDA 510(k)

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

K-Number: K231055 · 2023-12-28

ApplicantDe Götzen S.R.L.
Decision Date2023-12-28
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) is a medical device manufactured by De Götzen S.R.L.. It received FDA 510(k) clearance on 2023-12-28 under approval number K231055. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)?

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) is a medical device that received FDA 510(k) clearance on 2023-12-28. It is manufactured by De Götzen S.R.L.. The 510(k) number is K231055.

When was x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) approved by the FDA?

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) received FDA 510(k) clearance on 2023-12-28, under approval number K231055.

What company makes x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)?

x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) is manufactured by De Götzen S.R.L..

What is the FDA product code for x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)?

The FDA product code for x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) is EHD.

Related Clinical Trials

NCT05642195 Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer SUSPENDED

Other Devices by De Götzen S.R.L.

K203374X-MIND prime (under trade mark Acteon), I-MAX (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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