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510(k) K212456

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System by Hyperfine, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2021
Date Received
August 5, 2021
Clearance Type
Traditional
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.

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  • 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)
  • K221923 — Swoop Portable MR Imaging System (July 28, 2022)
  • K220815 — BrainInsight (July 19, 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)