510(k) K043271
- Device
- R2-MRI ANALYSIS SYSTEM
- Applicant
- INNER VISION BIOMETRICS PTY LTD
- 510(k) number
- K043271
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-01-21
- Date received
- 2004-11-26
- 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
- No
Applicant Contact#
- Contact
- JANET PREUSS
- Address
- 216 Stirling Hwy. Claremont, Perth AU 6010 6010
FDA Registration Numbers#
- 9611343
- 1055916
- 3026047529
- 3003661577
- 1721113
- 3026391023
- 3004531751
- 3014809646
- 3009882464
- 3004994584
- 1319639
- 3006262888
- 3005877899
- 1826555
- 1529041
- 3005810333
- 3016851825
- 3023385454
- 2520313
- 2126677
- 3015276088
- 3027325776
- 3003494057
- 3007734888
- 3012939903
- 1835830
- 3032109225
- 3007545404
- 3004859018
- 3004929307
- 3013679558
- 3008986341
- 3027373189
- 3012439308
- 3006621332
- 3003768277
- 2011171
- 3012169560
- 3018094310
- 3009714754
- 3017297314
- 2432211
- 3013695852
- 3015425142
- 3015232217
- 9617016
- 3006239787
- 3010703925
- 1058584
- 3005517190
- 3008496839
- 3014343100
- 3006738448
- 3016591365
- 3035950510
- 3014232555
- 3015329423
- 3013343065
- 3006073271
- 1221108
- 3011106828
- 3000126629
- 3009504230
- 3004526608
- 2247992
- 3012075008
- 3009755250
- 9614698
- 3014310698
- 3010701021
- 3014635027
- 3009154005
- 3009077524
- 3008447096
- 3021593788
- 3011416394
- 3014111222
- 3008284470
- 2183553
Source Documents#
Other 510(k) Records For Product Code LNH #
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|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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