510(k) K203273
- Device
- FibroScan® Family Of Products (Models: 502 Touch, 530 Compact, 430 Mini+, And 630)
- Applicant
- Echosens
- 510(k) number
- K203273
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-25
- Date received
- 2020-11-06
- 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
- Karine Bonenfant
- Address
- 6 Rue Ferrus Paris FR 75014 75014
FDA Registration Numbers#
- 3032109181
- 9680794
- 2244725
- 3032807464
- 9617277
- 3017487805
- 3010400367
- 3006161756
- 3015525240
- 3016253057
- 3019784575
- 3002183074
- 3010952312
- 9616774
- 3033557977
- 3017697447
- 3009565060
- 2182318
- 1220477
- 2184149
- 1527493
- 3002807715
- 3009293490
- 9613249
- 3007994837
- 3015551113
- 2133810
- 3015972810
- 3015276088
- 1450662
- 3014555455
- 3005877899
- 3008321254
- 3002315840
- 3014134519
- 2030624
- 3006979678
- 9680269
- 3016854601
- 3009077524
- 3013436538
- 3029937167
- 3013844297
- 3011416394
- 3001763079
- 3007695959
- 3025429169
- 3004574050
- 3002808148
- 3010827261
- 3003832357
- 3013515803
- 3039935725
- 3011278898
- 3003774756
- 3004035727
- 3014432311
- 3004485675
- 1720929
- 3040391009
- 2434141
- 3010398867
- 3015506965
- 1721686
- 3030733800
- 3003647374
- 9614587
- 3012428212
- 3035373446
- 9610632
- 9610595
- 1012187
- 3006597338
- 3011137372
- 3006330030
- 3008595936
- 3016696283
- 3042225166
- 9680579
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#
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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