Hyperfine, Inc
Guilford, CT, US
Hyperfine, Inc appears in FDA device records in Guilford, CT. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Hyperfine, Inc between 2021 and 2025. The busiest year on record is 2022, with 5. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 5 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253489 | Swoop® Portable MR Imaging® System | LNH | Substantially Equivalent | |
| K250236 | Swoop® Portable MR Imaging® System (V2) | LNH | Substantially Equivalent | |
| K251276 | Swoop® Portable MR Imaging® System | LNH | Substantially Equivalent | |
| K240944 | Swoop® Portable MR Imaging® System | LNH | Substantially Equivalent | |
| K232760 | Swoop® Portable MR Imaging System® | LNH | Substantially Equivalent | |
| K230208 | Swoop® Portable MR Imaging System™ | LNH | Substantially Equivalent | |
| K223268 | BrainInsight | QIH | Substantially Equivalent | |
| K223247 | Swoop Portable MR Imaging System | LNH | Substantially Equivalent | |
| K221923 | Swoop Portable MR Imaging System | LNH | Substantially Equivalent | |
| K220815 | BrainInsight | QIH | Substantially Equivalent | |
| K221393 | Swoop Portable MR Imaging System | LNH | Substantially Equivalent | |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | LNH | Substantially Equivalent | |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014310698 | 3014310698 | Hyperfine, Inc | 351 New Whitfield Street, Guilford, CT 06437 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain