12 devices · 1 company · 2021 to 2025
Hyperfine, Inc.: AI-enabled devices on FDA's list
12 devices from Hyperfine, Inc., 2021 to 2025, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (11 of 12 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Hyperfine, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Swoop Portable MR Imaging SystemK253489 · 510(k) | Radiology | LNH | database entry | |
| Swoop Portable MR Imaging SystemK250236 · 510(k) | Radiology | LNH | database entry | |
| Swoop Portable MR Imaging SystemK251276 · 510(k) | Radiology | LNH | database entry | |
| Swoop Portable MR Imaging SystemK240944 · 510(k) | Radiology | LNH | database entry | |
| Swoop Portable MR Imaging SystemK232760 · 510(k) | Radiology | LNH | database entry | |
| Swoop Portable MR Imaging SystemK230208 · 510(k) | Radiology | LNH | database entry | |
| BrainInsightK223268 · 510(k) | Radiology | QIH | database entry | |
| Swoop Portable MR Imaging SystemK223247 · 510(k) | Radiology | LNH | database entry | |
| Swoop Portable MR Imaging SystemK221923 · 510(k) | Radiology | LNH | database entry | |
| BrainInsightK220815 · 510(k) | Radiology | QIH | database entry | |
| Swoop Portable MR Imaging SystemK221393 · 510(k) | Radiology | LNH | database entry | |
| Swoop Point-of-Care Magnetic Resonance ImagingK212456 · 510(k) | Radiology | LNH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.