FDA 510(k)

Pixx2430 디지털 진단 X선 수신 패널

K-번호: K190691 · 2019-04-04

결정일2019-04-04

제품 코드MQB

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Pixx2430 Digital Diagnostic X-Ray Receptor Panel is the device name listed in this FDA 510(k) record. The listed applicant is Pixxgen Corporation. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K190691. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Pixx2430 Digital Diagnostic X-Ray Receptor Panel?

Pixx2430 Digital Diagnostic X-Ray Receptor Panel is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Pixxgen Corporation. The 510(k) number is K190691.

When did Pixx2430 Digital Diagnostic X-Ray Receptor Panel receive FDA 510(k) clearance?

Pixx2430 Digital Diagnostic X-Ray Receptor Panel received FDA 510(k) clearance on 2019-04-04, under 510(k) number K190691.

Who is the listed applicant for Pixx2430 Digital Diagnostic X-Ray Receptor Panel?

The FDA 510(k) record lists Pixxgen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pixx2430 Digital Diagnostic X-Ray Receptor Panel?

The FDA product code for Pixx2430 Digital Diagnostic X-Ray Receptor Panel is MQB.

Pixxgen Corporation를 신청인으로 등재한 기타 기록

K211108Prudent 1717, Prudent 1417, Prudent 1212 K182533PIXX 1717; PIXX 1417; PIXX 1212; 디지털 진단 X선 수신 패널 K180976PIXX 1717; PIXX 1417; PIXX 1212; 디지털 진단 X선 수신 패널

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