510(k) K003672
- Device
- MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
- Applicant
- MEDGE PLATFORMS, INC.
- 510(k) number
- K003672
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-02-22
- Date received
- 2000-11-28
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GUSTAVO EDUARDO ABELLA
- Address
- 90 Park Ave. 17th Floor New York NY US 10016 10016
FDA Registration Numbers#
- 3003412859
- 8043933
- 3010398867
- 1826555
- 3026405201
- 3016171942
- 3005636544
- 3045030482
- 3010400367
- 3012811961
- 3013944123
- 3012204368
- 3027501622
- 3008950127
- 3015972810
- 3006540052
- 2221819
- 3003832357
- 9680794
- 3014639846
- 8020021
- 3025429169
- 1450908
- 8010047
- 3001763079
- 3021226419
- 3014432311
- 3002807715
- 3034286426
- 3008729547
- 2936921
- 3012198618
- 9710090
- 1047843
- 3004753388
- 3017487805
- 3016076141
- 9613067
- 3011416394
- 3014574557
- 3024838922
- 3011200896
- 3006382185
- 2433682
- 3042225166
- 2024168
- 3016493665
- 3013757696
- 3017968993
- 1126271
- 3037874486
- 3014279513
- 3014134519
- 3003681187
- 3012761544
- 3011686611
- 3009499478
- 1224842
- 3010258456
- 2032350
- 1000269286
- 3033858858
- 3004035727
- 3006581049
- 3017057763
- 3016096098
- 3042172882
- 2134812
- 3032109181
- 3005334138
- 3008363989
- 3011648943
- 2522950
- 2031044
- 3033508292
- 9680269
- 3003857828
- 3017233611
- 3009715136
- 3016842138
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | 2026-09-24 |
| K253452 | Accuro 3S | Rivanna Medical, Inc. | 2026-07-24 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases