510(k) K233977
- Device
- Velacur
- Applicant
- Sonic Incytes
- 510(k) number
- K233977
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-04
- Date received
- 2023-12-18
- 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
- N
Related Records
Applicant Contact
- Contact
- Tinuade Orimalade
- Address
- #309-1788 W. 5th Ave. Vancouver CA V6J1P2 V6J1P2
FDA Registration Numbers
- 3002808148
- 2939830
- 1450662
- 3031397684
- 1319721
- 3031564213
- 1054713
- 3010457937
- 3011278898
- 1937397
- 3006260740
- 3011599810
- 1216677
- 2918630
- 3032367
- 3011411309
- 3010663777
- 3008487708
- 3011050570
- 3010390468
- 1319660
- 3017968993
- 3008950127
- 3008321254
- 3011416394
- 3010952312
- 3005810333
- 3025786376
- 3016171942
- 3003594449
- 3017406171
- 1066270
- 8043933
- 3014279513
- 3033508292
- 3007603826
- 9611343
- 3007015148
- 3012387143
- 3013041594
- 3040391009
- 3038718997
- 9612283
- 9610816
- 1450908
- 3003857828
- 3003600763
- 3011686611
- 3008223664
- 3005210579
- 3012198618
- 3012104670
- 2531814
- 3009756153
- 1000314502
- 2029275
- 2244725
- 3029744051
- 2936921
- 3008253300
- 3033275035
- 3007994837
- 3034286426
- 3006680097
- 3016271578
- 3033858858
- 3014639846
- 3032109225
- 3016493665
- 3014680735
- 9680671
- 3031158
- 1834003
- 9613067
- 9611031
- 3026047529
- 1224842
- 9611033
- 3006581049
Source Documents
Other 510(k) Records For Product Code IYO
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|---|---|---|---|
| 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 |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Fcu Co., Ltd. | 2024-06-26 |