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510(k) K221923

Swoop Portable MR Imaging System by Hyperfine, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2022
Date Received
July 1, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Hyperfine, Inc.

  • K253489 — Swoop® Portable MR Imaging® System (December 12, 2025)
  • K250236 — Swoop® Portable MR Imaging® System (V2) (May 30, 2025)
  • K251276 — Swoop® Portable MR Imaging® System (May 21, 2025)
  • K240944 — Swoop® Portable MR Imaging® System (July 16, 2024)
  • K232760 — Swoop® Portable MR Imaging System® (October 6, 2023)
  • K230208 — Swoop® Portable MR Imaging System™ (February 22, 2023)
  • K223268 — BrainInsight (December 16, 2022)
  • K223247 — Swoop Portable MR Imaging System (December 6, 2022)
  • K220815 — BrainInsight (July 19, 2022)
  • K221393 — Swoop Portable MR Imaging System (June 10, 2022)

Other clearances for product code LNH

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  • K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/Q (February 23, 2026)
  • K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (February 23, 2026)
  • K253780 — SIGNA™ Bolt (February 6, 2026)
  • K253779 — SIGNA™ Sprint Select (February 5, 2026)
  • K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System (January 26, 2026)
  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)