510(k) K252239
- Device
- InVision? 3T Recharge Operating Suite
- Applicant
- Imris Imaging, Inc.
- 510(k) number
- K252239
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-06
- Date received
- 2025-07-17
- Regulation
- 892.1000
- Classification name
- System, Nuclear Magnetic Resonance Imaging
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Disha Kabrawala
- Address
- 1230 Chaska Creek Way, Suite 100 Chaska MN US 55318 55318
FDA Registration Numbers#
- 3010009632
- 1650907
- 3002808157
- 3007546534
- 3010326005
- 3011950073
- 3018423337
- 1529041
- 3034286426
- 3015431711
- 3026391023
- 2432211
- 3003494057
- 9616047
- 3017297314
- 3012761544
- 3012127758
- 2183553
- 2520313
- 3011657336
- 2126677
- 3031503890
- 3008632256
- 3014809646
- 3011015597
- 3008284470
- 3027373189
- 3023003446
- 3006738448
- 2011171
- 3010703925
- 3026047529
- 1054713
- 3012085143
- 3029521953
- 3014343100
- 3036666444
- 3035950510
- 2029299
- 3017383732
- 3010701021
- 3004994584
- 3008986341
- 3003768277
- 3012075008
- 3019844073
- 1826555
- 3005450718
- 3006239787
- 3009154005
- 3012439308
- 3014111222
- 3007734888
- 3005049692
- 3004531751
- 2134213
- 1835830
- 3030982377
- 3008447096
- 3011416394
- 3021059265
- 1038814
- 3006015847
- 3019595609
- 3033333119
- 1055916
- 3015223550
- 3009755250
- 3011767965
- 1721113
- 3032109181
- 3016727312
- 2247992
- 3005877899
- 3018094310
- 3009504230
- 3014232555
- 1063285
- 3015232217
Source Documents#
Other 510(k) Records For Product Code LNH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| K253780 | SIGNA™ Bolt | Ge Medical Systems, LLC | 2026-02-06 |
| K253779 | SIGNA™ Sprint Select | Ge Medical Systems, LLC | 2026-02-05 |