510(k) K092140
- Device
- GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
- Applicant
- GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
- 510(k) number
- K092140
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-08-21
- Date received
- 2009-07-15
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES TURNER
- Address
- 3000 N. Grandview Blvd. Waukesha WI US 53188 53188
FDA Registration Numbers#
- 3006597338
- 3009407891
- 3010220244
- 3008496839
- 3003832357
- 3019216
- 3010034260
- 9617592
- 2954783
- 3032008018
- 3007994837
- 3015525240
- 3016171942
- 3010082909
- 3005860720
- 2031044
- 3025786376
- 3011200896
- 9680671
- 2244725
- 3038718997
- 2134848
- 3002315840
- 1319660
- 3011106828
- 3012939903
- 3008640801
- 1000391004
- 3010041511
- 3034286426
- 3010381606
- 3012981490
- 3027501622
- 3017263724
- 1222780
- 3005334138
- 9610482
- 3011416394
- 2030624
- 1055236
- 3010102386
- 3012198618
- 1720929
- 9611125
- 3006110251
- 3005877899
- 3009756153
- 3014639846
- 3033858858
- 3014432311
- 3005810333
- 3034232408
- 3010398867
- 1528028
- 3004009431
- 3001763079
- 3003681187
- 3029744051
- 3037874486
- 3008321254
- 3029906632
- 8043933
- 3032109225
- 3026405201
- 3009565060
- 3009499478
- 3009715136
- 3012104670
- 3008132411
- 3021226419
- 3044744649
- 3007738736
- 3006680097
- 1126271
- 3011278898
- 2320762
- 3003589956
- 3008950127
- 3009247326
Source Documents#
Other 510(k) Records For Product Code IYO #
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|---|---|---|---|
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 |
| K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026-04-17 |
| K254021 | Accuro XV | Rivanna Medical, Inc. | 2026-04-09 |
| K253898 | QT Scanner 2000 Model A | QT Imaging Holdings, Inc. | 2026-03-04 |
| K253714 | IntraSight Plus | Philips Image Guided Therapy Corporation | 2026-02-24 |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) | Eieling Technology (Shenzhen) Limited | 2026-02-06 |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025-09-30 |
| K250381 | Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. | 2025-08-01 |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | 2025-07-11 |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | 2025-06-26 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 |
| K243937 | Accuro 3S | Rivanna Medical, Inc. | 2025-05-23 |
| K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025-04-23 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
| K241029 | SpineUs™ System | Verdure Imaging | 2024-10-07 |
Legacy Summary#
summary
FDA Review#
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