510(k) K922647
- Device
- COLOR DISKSTORE
- Applicant
- CAMTRONICS, LTD.
- 510(k) number
- K922647
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-08-11
- Date received
- 1992-06-03
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- SCOTT PEASE
- Address
- 900 Walnut Ridge Dr. P.O. Box 950 Hartland WI US 53029 53029
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
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| 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 |
| K233977 | Velacur | Sonic Incytes | 2024-09-04 |
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