FDA 510(k)

DX-D 이미징 패키지 with XD探测器

K-번호: K211790 · 2021-07-30

결정일2021-07-30

제품 코드MQB

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

결정대체적으로 동일

기기 요약

DX-D Imaging Package with XD Detectors is the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211790. 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 DX-D Imaging Package with XD Detectors?

DX-D Imaging Package with XD Detectors is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Agfa N.V.. The 510(k) number is K211790.

When did DX-D Imaging Package with XD Detectors receive FDA 510(k) clearance?

DX-D Imaging Package with XD Detectors received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211790.

Who is the listed applicant for DX-D Imaging Package with XD Detectors?

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

What is the FDA product code for DX-D Imaging Package with XD Detectors?

The FDA product code for DX-D Imaging Package with XD Detectors is MQB.

Agfa N.V.를 신청인으로 등재한 기타 기록

K213469VALORY K212145DR 800과 DSA, DR 800 K193262DR 600 토폴로시스와 함께 K191884DR 100s K183275DR 800 토모시네스스와 함께

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