Swoop® Portable MR Imaging® System— 510(k) K262622
Substantially EquivalentHyperfine, Inc.
FDA 510(k) clearance K262622 for Swoop® Portable MR Imaging® System, Substantially Equivalent on 2026-08-19. Applicant: Hyperfine, Inc.. Device class: 2.
Summary
Hyperfine's Swoop Portable MR Imaging System is filed under product code LNH, nuclear magnetic resonance imaging systems. No model numbers are listed.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and the submission type is Special.
The record lists the applicant location as Guilforf, Connecticut. FDA found it substantially equivalent 22 calendar days after receipt (July 28 to August 19, 2026).
Clearance details
- Applicant
- Hyperfine, Inc.
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Guilforf, CT, US
Recent devices under product code LNH
view allMore clearances from Hyperfine, Inc.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.