| Primary Device ID | 00850043319160 |
| NIH Device Record Key | 4a545224-e3a8-4c49-acdf-a841d073ae61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Swoop Portable MR Imaging Scanner |
| Version Model Number | v2.2 |
| Catalog Number | 900-11050-02 |
| Company DUNS | 051795046 |
| Company Name | Hyperfine Operations, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850043319160 [Primary] |
| LNH | System, Nuclear Magnetic Resonance Imaging |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-12 |
| Device Publish Date | 2025-12-04 |
| 00850043319160 - Swoop Portable MR Imaging Scanner | 2025-12-12Portable MR Scanner (v2.2) |
| 00850043319160 - Swoop Portable MR Imaging Scanner | 2025-12-12 Portable MR Scanner (v2.2) |
| 00850043319184 - Swoop Transmit and Receive Radio Frequency Head Coil | 2025-12-12 The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is us |
| 00850043319047 - Hyperfine Foam Head Pad | 2025-03-13 Memory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure. |