510(k) K914536
- Device
- MODELS 190GE-64/191GE-64/192GE-64/193GE-64
- Applicant
- MEDICAL ADVANCES, INC.
- 510(k) number
- K914536
- Product code
- LNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-11-27
- Date received
- 1991-10-11
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS TYNES
- Address
- 10431 W. Watertown Plank Rd. P.O. Box 26425 Milwaukee WI US 53226 53226
FDA Registration Numbers#
- 2029299
- 1723170
- 3008632256
- 2432211
- 1221108
- 3006262888
- 3023003446
- 3006738448
- 3015223550
- 3033527281
- 3006849754
- 3009882464
- 3004531751
- 9616047
- 3017383732
- 3016727312
- 9617277
- 3027339477
- 3019595609
- 3014232555
- 3013679558
- 3005517190
- 3015425142
- 3023385454
- 3013695852
- 3027325776
- 3012761544
- 9611343
- 3009755250
- 2520313
- 3002808157
- 3013343065
- 1650907
- 3021593788
- 3008355361
- 3010398867
- 3004526608
- 3012439308
- 3031503890
- 3004977335
- 3036666444
- 1054713
- 3008447096
- 3010703925
- 1721113
- 3011657336
- 3007545404
- 3007562060
- 3008284470
- 3006369484
- 9617016
- 3016591365
- 3008496839
- 8043485
- 3010009632
- 1058584
- 3009714754
- 3020162557
- 3032109225
- 3015276088
- 3011416394
- 3021059265
- 3033536331
- 2126677
- 3018004899
- 3009963139
- 3012085143
- 3014809646
- 3009715136
- 3005450718
- 3032109181
- 3016851825
- 3004754211
- 3015431711
- 3017297314
- 3012354318
- 3009504230
- 3026047529
- 1063285
Source Documents#
510(k) summary PDF not indicated by FDA
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| 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 |
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Legacy Summary#
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FDA Review#
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