Hyperfine, Inc.

12 AI-enabled medical devices from Hyperfine, Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2025-12-12K253489Swoop® Portable MR Imaging® SystemHyperfine, Inc.Radiology
2025-05-30K250236Swoop® Portable MR Imaging® System (V2)Hyperfine, Inc.Radiology
2025-05-21K251276Swoop® Portable MR Imaging® SystemHyperfine, Inc.Radiology
2024-07-16K240944Swoop® Portable MR Imaging® SystemHyperfine, Inc.Radiology
2023-10-06K232760Swoop® Portable MR Imaging System®Hyperfine, Inc.Radiology
2023-02-22K230208Swoop® Portable MR Imaging System™Hyperfine, Inc.Radiology
2022-12-16K223268BrainInsightHyperfine, Inc.Radiology
2022-12-06K223247Swoop Portable MR Imaging SystemHyperfine, Inc.Radiology
2022-07-28K221923Swoop Portable MR Imaging SystemHyperfine, Inc.Radiology
2022-07-19K220815BrainInsightHyperfine, Inc.Radiology
2022-06-10K221393Swoop Portable MR Imaging SystemHyperfine, Inc.Radiology
2021-11-17K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc.Radiology

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