Company profile

Hyperfine, Inc.

Hyperfine, Inc. has 12 AI-enabled medical devices on the FDA list. The first decision was on November 17, 2021 and the most recent on December 12, 2025 (Swoop® Portable MR Imaging® System). Its most common review panel is Radiology (12 devices).

12AI devices

2021First decision

2025Latest decision

1Specialties

Per year

20212022202320242025

Hyperfine, Inc. AI devices per year: 2021 1, 2022 5, 2023 2, 2024 1, 2025 3

By specialty

Radiology12

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Timeline

December 12, 2025 · 510(k) K253489Swoop® Portable MR Imaging® System · Radiology · LNH
May 30, 2025 · 510(k) K250236Swoop® Portable MR Imaging® System (V2) · Radiology · LNH
May 21, 2025 · 510(k) K251276Swoop® Portable MR Imaging® System · Radiology · LNH
July 16, 2024 · 510(k) K240944Swoop® Portable MR Imaging® System · Radiology · LNH
October 6, 2023 · 510(k) K232760Swoop® Portable MR Imaging System® · Radiology · LNH
February 22, 2023 · 510(k) K230208Swoop® Portable MR Imaging System · Radiology · LNH
December 16, 2022 · 510(k) K223268BrainInsight · Radiology · QIH
December 6, 2022 · 510(k) K223247Swoop Portable MR Imaging System · Radiology · LNH
July 28, 2022 · 510(k) K221923Swoop Portable MR Imaging System · Radiology · LNH
July 19, 2022 · 510(k) K220815BrainInsight · Radiology · QIH
June 10, 2022 · 510(k) K221393Swoop Portable MR Imaging System · Radiology · LNH
November 17, 2021 · 510(k) K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System · Radiology · LNH