510(k) K082229
- Device
- S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
- Applicant
- VOLCANO CORPORATION
- 510(k) number
- K082229
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-08
- Date received
- 2008-08-07
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAMTA VATS
- Address
- 2870 Kilgore Rd.. Rancho Cordova, CA US 95670 95670
FDA Registration Numbers#
- 3013436538
- 3006786907
- 3011763071
- 3003832357
- 3017697447
- 3003594449
- 3012747207
- 3013764800
- 3016696283
- 1720929
- 3008355361
- 3008506949
- 3012081348
- 3033275035
- 1000602763
- 1224842
- 1222780
- 9611033
- 3012387143
- 3008595936
- 2133641
- 2936921
- 9615439
- 3017263724
- 3011106828
- 3021970996
- 3016842138
- 3005785090
- 3014574557
- 3029937167
- 3014639846
- 2184149
- 3015506965
- 2531814
- 3014555455
- 3011396687
- 9611343
- 3005334138
- 3010398867
- 3004009431
- 3019216
- 3015997711
- 3017487805
- 3033743848
- 2024024
- 3038718997
- 3010703925
- 3012127758
- 3006581049
- 1043214
- 3004035727
- 9710602
- 3017654247
- 1527493
- 3009600098
- 3014432311
- 3008640801
- 3009565060
- 3007015148
- 1319660
- 9615849
- 3011416394
- 3012494290
- 2011171
- 8010047
- 3043534483
- 1422634
- 9614587
- 3010193531
- 3017968993
- 8041160
- 3019784575
- 1220477
- 9610482
- 2244725
- 1000269286
- 3027501622
- 2134243
- 3034232408
- 3009435759
Source Documents#
Other 510(k) Records For Product Code IYO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Eieling Technology (Shenzhen) Limited | 2024-11-19 |
Legacy Summary#
summary
FDA Review#
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