510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K262622Substantially Equivalent

Swoop® Portable MR Imaging® System

Hyperfine, Inc., Guilforf CT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K262622 is the FDA 510(k) clearance record for Swoop® Portable MR Imaging® System, a class II device, cleared for Hyperfine, Inc. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). As of , FDA records show no recalls naming K262622.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Hyperfine, Inc. 351 New Whitfield St., Guilforf CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LNH

Trailing 12 months
25 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20260