510(k) K142341
- Device
- X-RAY TV SYSTEM SONIALVISION G4
- Applicant
- SHIMADZU CORP.
- 510(k) number
- K142341
- Product code
- JAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-06
- Date received
- 2014-08-21
- Regulation
- 892.1650
- Classification name
- System, X-ray, Fluoroscopic, Image-intensified
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOSHIO KADOWAKI
- Address
- 1 Nishinokyo-Kuwabaracho Nakaygo-Ku Kyoto JP 604-8511 604-8511
FDA Registration Numbers#
- 3010685285
- 3014273597
- 3005843418
- 3005810333
- 3014391847
- 3036666444
- 1125622
- 3014343100
- 1056553
- 3007289408
- 2133772
- 3011491794
- 3008044777
- 8030233
- 3003600763
- 3004977335
- 3011416394
- 8021091
- 1720753
- 3010202439
- 1047843
- 2936485
- 3018094310
- 3021059265
- 3009973505
- 8030112
- 3009196578
- 3006544299
- 1048735
- 1054241
- 9611343
- 3042175844
- 1000181430
- 1052701
- 9611388
- 3010398867
- 1018470
- 2031966
- 3009144915
- 9710018
- 3021559833
- 3013099020
- 3009963139
- 3010703925
- 3027373189
- 9610903
- 3015276088
- 3035950510
- 3007143236
- 3033527770
- 3003314115
- 9614698
- 3003927316
- 3001722928
- 9613347
- 1055236
- 2126677
- 3011713200
- 3027339477
- 3005877899
- 1061158
- 3003935342
- 1225677
- 8020997
- 3003775006
- 2020550
- 3003202425
- 3004026651
- 3014634069
- 3010162973
- 3016438694
- 3004911384
- 3004785967
- 3008632256
- 3011950073
- 3016619943
- 3021060474
- 3014925393
- 9616491
Source Documents#
Other 510(k) Records For Product Code JAA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251650 | Insight Enhanced™ DRF (EN-1002-01) | Imaging Engineering, LLC | 2025-09-16 |
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | 2025-01-06 |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | 2024-12-23 |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | 2024-06-26 |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | 2024-01-11 |
| K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2023-10-19 |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | 2023-09-12 |
| K220871 | Nautilus | Dornier Medtech America, Inc. | 2022-04-18 |
| K212890 | Nyquist.IQ | Omega Medical Imaging, LLC | 2021-12-13 |
| K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021-09-21 |
| K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | 2021-08-31 |
| K210469 | Insight Agile DRF | Imaging Engineering, LLC | 2021-07-27 |
| K203428 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2021-03-17 |
| K203010 | Platinum dRF Imaging System | Apelem-Dms Group | 2021-01-22 |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | 2020-12-29 |
Legacy Summary#
summary
FDA Review#
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