FDA 510(k)

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

K-번호: K212456 · 2021-11-17

결정일2021-11-17

제품 코드LNH

자문 위원회RA

결정Substantially Equivalent

기기 요약

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine, Inc.. It received FDA 510(k) clearance on 2021-11-17 under 510(k) number K212456. 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 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is a medical device that received FDA 510(k) clearance on 2021-11-17. The listed applicant is Hyperfine, Inc.. The 510(k) number is K212456.

When did Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System receive FDA 510(k) clearance?

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System received FDA 510(k) clearance on 2021-11-17, under 510(k) number K212456.

Who is the listed applicant for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

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

What is the FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

The FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is LNH.

Hyperfine, Inc.를 신청인으로 등재한 기타 기록

K262622Swoop® Portable MR Imaging® System K253489Swoop® Portable MR Imaging® System K250236Swoop® Portable MR Imaging® System (V2)K251276Swoop® Portable MR Imaging® System K240944Swoop® Portable MR Imaging® System K232760Swoop® Portable MR Imaging System®

14개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.