510(k) K072797
- Device
- GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
- Applicant
- GENERAL ELECTRIC CO.
- 510(k) number
- K072797
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-10-17
- Date received
- 2007-10-01
- 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
- ALLEN SCHUH
- Address
- 9900 Innovation Dr. Mail Code: Rp-2138 Wauwatosa WI US 53226 53226
FDA Registration Numbers#
- 1422634
- 3005785090
- 3005099803
- 3005403518
- 1000269286
- 3014555455
- 3008386005
- 3002183074
- 2031962
- 3027501622
- 3009499478
- 3014745562
- 9613067
- 3007695959
- 3006161756
- 2531475
- 3007194257
- 9616774
- 2244725
- 2518897
- 3012204368
- 1054241
- 3008496839
- 3031158
- 3010610157
- 3006581049
- 2939830
- 1222780
- 3010041511
- 2518586
- 3042585081
- 3011763071
- 3016854601
- 3042172882
- 9615439
- 3009756153
- 3015151147
- 3015972810
- 3012387143
- 3004574050
- 3008132411
- 2134812
- 3004705634
- 3042225166
- 3007562060
- 1012187
- 3023245
- 2030624
- 3012081348
- 3009407891
- 3016678045
- 3032367
- 3009196578
- 3003647374
- 3010952312
- 3013041594
- 3014432311
- 2531814
- 3005646850
- 3010258456
- 2134848
- 3011692238
- 3006110251
- 2025099
- 9611125
- 8020021
- 3017894900
- 1055236
- 3017057763
- 3002807715
- 3033527283
- 2029275
- 3011200896
- 3038718997
- 3033557977
- 3032109181
- 3015506965
- 3019216
- 2133810
- 3005636544
Source Documents#
Other 510(k) Records For Product Code IYO #
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|---|---|---|---|
| K260190 | ARTHUR | ROPCA ApS | 2026-06-18 |
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| 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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