510(k) K232760
- Device
- Swoop® Portable MR Imaging System®
- Applicant
- Hyperfine, Inc.
- 510(k) number
- K232760
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-06
- Date received
- 2023-09-08
- 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
Related Records
Applicant Contact
- Contact
- Christine Kupchick
- Address
- 351 New Whitfield St. Guilforf CT US 06437 06437
FDA Registration Numbers
- 3006369484
- 3030982377
- 3019595609
- 3005810333
- 3004526608
- 3007734888
- 3036666444
- 3009882464
- 3014343100
- 1835830
- 3033536331
- 3027325776
- 3004929307
- 3005450718
- 3009714754
- 3006262888
- 3016591365
- 3042177665
- 2520313
- 3004977335
- 3011416394
- 3007545404
- 3005976071
- 3018094310
- 3021059265
- 2011171
- 3009196578
- 3002808157
- 3023385454
- 1319639
- 1932738
- 3006015847
- 9611343
- 3006073271
- 3012085143
- 3010398867
- 3008355361
- 3005049692
- 3013875850
- 3013679558
- 3009963139
- 1721113
- 3010703925
- 3027373189
- 1063285
- 3015276088
- 3033527281
- 3014680716
- 2134213
- 3014809646
- 3014232555
- 9614698
- 3015425142
- 3017383732
- 2126677
- 3027339477
- 3005877899
- 3009154005
- 3029521953
- 1221108
- 3008156140
- 3014635027
- 3012075008
- 3013695852
- 3005517190
- 9617016
- 3003661577
- 3010949642
- 1038814
- 3011767965
- 3017297314
- 3011106828
- 3019844073
- 3015329423
- 1526534
- 3016851825
- 3007350713
- 3008632256
- 3014111222
Source Documents
Other 510(k) Records For Product Code LNH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260113 | uMR Astra | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| K253862 | APERTO Lucent MRI System | Fujifilm Corporation | 2026-04-06 |
| K260746 | S-scan Open (100001800) | Esaote, S.p.A. | 2026-03-27 |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | 2026-03-27 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 |
| K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026-03-09 |
| K251901 | Magnifico Open (100009900) | Esaote, S.p.A. | 2026-03-05 |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades | Philips Medical Systems Nederland B.V. | 2026-02-23 |
| K253780 | SIGNA Bolt | Ge Medical Systems, LLC | 2026-02-06 |
| K253779 | SIGNA Sprint Select | Ge Medical Systems, LLC | 2026-02-05 |
| K253499 | Ascent3T Neonatal Magnetic Resonance Imaging System | Eyas Medical Imaging, Inc. | 2026-01-26 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | 2025-12-19 |