510(k) K082964
- Device
- PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
- Applicant
- PRISM CLINICAL IMAGING, INC.
- 510(k) number
- K082964
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-09
- Date received
- 2008-10-03
- 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
- JAMES L REUSS
- Address
- 851 S. 70th St., Suite 103 West Allis WI US 53214 53214
FDA Registration Numbers#
- 3007562060
- 3004531751
- 3023003446
- 3017297314
- 3010398867
- 3015431711
- 1826555
- 3003768277
- 3004526608
- 3016727312
- 3014310698
- 3021593788
- 3006262888
- 3004994584
- 3042177665
- 3023385454
- 3008496839
- 1835830
- 3009963139
- 3013875850
- 3011015597
- 3033333119
- 3017375271
- 3021059265
- 3007734888
- 3015329423
- 3005450718
- 3036666444
- 3013343065
- 3006369484
- 3010326005
- 3019844073
- 3009755250
- 3005810333
- 2134213
- 3014343100
- 3018423337
- 3009196578
- 3026391023
- 1529041
- 3010949642
- 3010701021
- 3006073271
- 3009504230
- 3004754211
- 3003661577
- 3018004899
- 3031503890
- 3007545404
- 9616047
- 3034286426
- 2520313
- 3020162557
- 1055916
- 3011106828
- 3027339477
- 1721113
- 3009882464
- 3010009632
- 3006239787
- 1221108
- 3009714754
- 3008156140
- 3027373189
- 3015232217
- 3017383732
- 3005877899
- 3019595609
- 3014635027
- 3005517190
- 3011416394
- 3030982377
- 3029521953
- 3012085143
- 3018094310
- 9617277
- 2011171
- 3007546534
- 3006621332
Source Documents#
Other 510(k) Records For Product Code LNH #
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|---|---|---|---|
| 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 |
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 |
| K254277 | Embrace Neonatal MRI System | Aspect Imaging, Ltd. | 2026-03-13 |
Legacy Summary#
summary
FDA Review#
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