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510(k) K230208

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2023
Date Received
January 25, 2023
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)
  • 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)
  • K221393 — Swoop Portable MR Imaging System (June 10, 2022)

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  • K252379 — AIR Recon DL (December 23, 2025)
  • K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETO (December 19, 2025)