510(k) clearance

Swoop® Portable MR Imaging® System

FDA 510(k) source

510(k) number

K262622

Applicant

Hyperfine, Inc.

Decision date

Aug 19, 2026

Date received

Jul 28, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

LNH

Device type

System, Nuclear Magnetic Resonance Imaging

Device class

Class II

Regulation

21 CFR 892.1000

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Guilforf, CT, US