FDA 510(k)

루시 포인트 오브 케어 마그넷트 레콘 애니메이션 디바이스

K-번호: K192002 · 2020-02-06

결정일2020-02-06

제품 코드LNH

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

결정대체적으로 동일

기기 요약

Lucy Point-of-Care Magnetic Resonance Imaging Device is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine Research, Inc.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K192002. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Lucy Point-of-Care Magnetic Resonance Imaging Device?

Lucy Point-of-Care Magnetic Resonance Imaging Device is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Hyperfine Research, Inc.. The 510(k) number is K192002.

When did Lucy Point-of-Care Magnetic Resonance Imaging Device receive FDA 510(k) clearance?

Lucy Point-of-Care Magnetic Resonance Imaging Device received FDA 510(k) clearance on 2020-02-06, under 510(k) number K192002.

Who is the listed applicant for Lucy Point-of-Care Magnetic Resonance Imaging Device?

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

What is the FDA product code for Lucy Point-of-Care Magnetic Resonance Imaging Device?

The FDA product code for Lucy Point-of-Care Magnetic Resonance Imaging Device is LNH.

Hyperfine Research, Inc.를 신청인으로 등재한 기타 기록

K202414브레인아이싱트 K201722고정밀 포인트-오브-케어 마그넷 공명 영상 검사기(POC MRI) 스캐너 시스템

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