FDA 510(k)

클리어리드 X선 폐장막파

K-번호: K213566 · 2022-03-10

결정일2022-03-10

제품 코드QFM

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

결정대체적으로 동일

기기 요약

ClearRead Xray Pneumothorax is the device name listed in this FDA 510(k) record. The listed applicant is Riverain Technologies, Inc.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213566. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ClearRead Xray Pneumothorax?

ClearRead Xray Pneumothorax is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Riverain Technologies, Inc.. The 510(k) number is K213566.

When did ClearRead Xray Pneumothorax receive FDA 510(k) clearance?

ClearRead Xray Pneumothorax received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213566.

Who is the listed applicant for ClearRead Xray Pneumothorax?

The FDA 510(k) record lists Riverain Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearRead Xray Pneumothorax?

The FDA product code for ClearRead Xray Pneumothorax is QFM.

Riverain Technologies, Inc.를 신청인으로 등재한 기타 기록

K242188클리어리드 CT CAC K221612클리어리드 CT

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