FDA-cleared K212456
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-11-17
Vendor
Hyperfine, Inc.
12 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K221393
Swoop Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-06-10
FDA-cleared K220815
BrainInsight
Hyperfine, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-07-19
FDA-cleared K221923
Swoop Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-07-28
FDA-cleared K223247
Swoop Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2022-12-06
FDA-cleared K223268
BrainInsight
Hyperfine, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-12-16
FDA-cleared K230208
Swoop® Portable MR Imaging System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-02-22
FDA-cleared K232760
Swoop® Portable MR Imaging System®
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-10-06
FDA-cleared K240944
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-07-16
FDA-cleared K251276
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-21
FDA-cleared K250236
Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-05-30
FDA-cleared K253489
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-12