510(k) K203719
- Device
- IntraSight Mobile
- Applicant
- Volcano Corporation
- 510(k) number
- K203719
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-19
- Date received
- 2020-12-21
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Linda Schulz
- Address
- 3721 Valley Centre Dr., Suite 500 San Diego CA US 92130 92130
FDA Registration Numbers#
- 2184149
- 3008515880
- 3015542130
- 3026405201
- 3017955833
- 3006680097
- 3006597338
- 1826555
- 3010381606
- 3010390468
- 3004009431
- 3015276088
- 3006110251
- 3005646850
- 3016678045
- 3031259044
- 3031397684
- 3033527241
- 3017233611
- 3042172882
- 9680794
- 3022472
- 3016436764
- 3019784575
- 3012428212
- 3033710058
- 3038718997
- 3005636544
- 9615439
- 3014574557
- 1000601180
- 3015151147
- 3002807715
- 1061124
- 2031962
- 9610816
- 3011106828
- 9710602
- 9614698
- 3015551113
- 2532090
- 3008950127
- 3029906632
- 3009565060
- 8043817
- 3016493665
- 3029937167
- 3007994837
- 9680269
- 3008355361
- 1720929
- 3012494290
- 2030624
- 3003971136
- 1047843
- 3037874486
- 3009212453
- 3009156722
- 3010457937
- 2320762
- 3003681187
- 2133641
- 3003832357
- 2134265
- 3010034260
- 1650907
- 3017406171
- 1226587
- 3005406110
- 3018884581
- 3011692238
- 2124215
- 3017894900
- 3021226419
- 3013840437
- 2221819
- 3031569584
- 3014134519
- 3001722928
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#
summary
FDA Review#
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