FDA 510(k)

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

K-번호: K203374 · 2021-02-05

결정일2021-02-05

제품 코드MUH

자문 위원회DE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

De Götzen S.R.L.를 신청인으로 등재한 기타 기록

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

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