FDA 510(k) clearance · back to tracker

Swoop® Portable MR Imaging® System

Hyperfine, Inc. cleared K240944 on 2024-07-16, decision: substantially equivalent

K-number

K240944

Sponsor

Hyperfine, Inc.

Device

Swoop® Portable MR Imaging® System

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-07-16

Product code

LNH

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1000

Official FDA record

Open K240944on accessdata.fda.gov →

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

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K240944 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

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