510(k) K221923
- Device
- Swoop Portable MR Imaging System
- Applicant
- Hyperfine, Inc.
- 510(k) number
- K221923
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-28
- Date received
- 2022-07-01
- Regulation
- 892.1000
- Classification name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Christine Kupchick
- Address
- 351 New Whitfield St. Guilforf CT US 06437 06437
FDA Registration Numbers#
- 3009715136
- 3013679558
- 3006849754
- 3009963139
- 1319639
- 3008284470
- 3017375271
- 3015431711
- 3042177665
- 3025602463
- 3009882464
- 3005976071
- 3014635027
- 9611343
- 3032109181
- 3010009632
- 3003661577
- 3006073271
- 3010701021
- 3008986341
- 3009196578
- 3013343065
- 3010703925
- 3008355361
- 3007350713
- 3009714754
- 3004929307
- 3014809646
- 3018004899
- 9616047
- 3012075008
- 3007546534
- 3011015597
- 3011657336
- 2126677
- 3009504230
- 3008632256
- 3030982377
- 2432211
- 3012085143
- 3006015847
- 1054713
- 3016591365
- 3021593788
- 3010398867
- 3033333119
- 2520313
- 3019595609
- 3016727312
- 3023003446
- 3011767965
- 3007734888
- 3027325776
- 3012439308
- 1650907
- 2183553
- 3014343100
- 3015276088
- 3012761544
- 3027339477
- 3015223550
- 3036666444
- 3032109225
- 3006621332
- 3016851825
- 3035950510
- 3015425142
- 9617016
- 3007562060
- 3004531751
- 3009154005
- 3029521953
- 3031503890
- 3009077524
- 3011950073
- 3005326970
- 1826555
- 3012127758
- 3034286426
Source Documents#
Other 510(k) Records For Product Code LNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262902 | ECHELON Synergy | Fujifilm Corporation | 2026-10-09 |
| K260092 | Vista AI Scan | Vista AI, Inc. | 2026-10-07 |
| K261612 | SwiftSight-BodyComposition | Airs Medical, Inc. | 2026-10-01 |
| K261283 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-09-16 |
| K261758 | Embrace Vision Neonatal MRI System | Aspect Imaging, Ltd. | 2026-09-16 |
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-09-01 |
| K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | 2026-08-19 |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | 2026-08-17 |
| K253808 | AIR Recon DL | GE Medical Systems | 2026-08-13 |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | 2026-07-31 |
| K261331 | I-Genius (100019400) | Esaote, S.p.A. | 2026-07-31 |
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-04-06 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2026-03-27 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases