510(k) K090773
- Device
- CFI ULTRASOUND PROBE DRAPE
- Applicant
- CONTOUR FABRICATORS, INC.
- 510(k) number
- K090773
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-09-18
- Date received
- 2009-03-23
- 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
- JOHN W SCHAEFER
- Address
- 14241 Fenton Rd. Fenton MI US 48430 48430
FDA Registration Numbers#
- 3013757696
- 3017697447
- 3012198618
- 2245304
- 3008595936
- 3008921662
- 3037874486
- 1047843
- 2182318
- 3011763071
- 2032350
- 3003774756
- 2521877
- 1000513161
- 3011692238
- 3007738736
- 3012081348
- 3010034260
- 9614698
- 3010193531
- 3003857828
- 3011688715
- 8041160
- 3009758186
- 3031564213
- 3009435759
- 3007994837
- 3031259044
- 3022472
- 2024168
- 9611033
- 3017406171
- 3011648943
- 3011137372
- 3044744649
- 3029937167
- 3006330030
- 1055236
- 3015973732
- 9710602
- 3029906632
- 3033858858
- 1319660
- 2434141
- 3002808148
- 9613067
- 1937397
- 3002183074
- 3033557977
- 3006110251
- 3014755924
- 3012747207
- 1054241
- 9610632
- 3010102386
- 3026405201
- 1834003
- 3011200896
- 3004035727
- 3006540052
- 3017944270
- 3016493665
- 3033527241
- 9615439
- 3010390468
- 2011171
- 3017955833
- 3038718997
- 2531814
- 3019216
- 2025099
- 2518897
- 9610482
- 2031962
- 3003589956
- 3045030482
- 3002807315
- 1721676
- 1061124
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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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