FDA 510(k) clearance · back to tracker

Swoop Portable MR Imaging System

Hyperfine, Inc. cleared K223247 on 2022-12-06, decision: substantially equivalent

K-number

K223247

Sponsor

Hyperfine, Inc.

Device

Swoop Portable MR Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2022-12-06

Product code

LNH

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1000

Official FDA record

Open K223247on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.