FDA 510(k)

DR 600 토폴로시스와 함께

K-번호: K193262 · 2020-03-09

결정일2020-03-09

제품 코드IZF

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

결정대체적으로 동일

기기 요약

DR 600 with Tomosynthesis 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 2020-03-09 under 510(k) number K193262. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DR 600 with Tomosynthesis?

DR 600 with Tomosynthesis is a medical device that received FDA 510(k) clearance on 2020-03-09. The listed applicant is Agfa N.V.. The 510(k) number is K193262.

When did DR 600 with Tomosynthesis receive FDA 510(k) clearance?

DR 600 with Tomosynthesis received FDA 510(k) clearance on 2020-03-09, under 510(k) number K193262.

Who is the listed applicant for DR 600 with Tomosynthesis?

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 DR 600 with Tomosynthesis?

The FDA product code for DR 600 with Tomosynthesis is IZF.

Agfa N.V.를 신청인으로 등재한 기타 기록

K213469VALORY K212145DR 800과 DSA, DR 800 K211790DX-D 이미징 패키지 with XD探测器 K191884DR 100s K183275DR 800 토모시네스스와 함께

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