# Echosens

- Location (FDA's records): Paris, FR
- FDA decisions: 11 (2013–2023): 11 510(k) clearances
- Product codes: IYO (11)
- 510(k) review time since 2016: median 53 days, against 64 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 16 (12 its own); citations of its devices by later devices: 22 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Supersonic Imagine: 3 (https://510kreport.com/company/supersonic-imagine)
- Delphinus Medical Technologies: 1 (https://510kreport.com/company/delphinus-medical-technologies)

## Firms that cite its devices most
- Wuxi Hisky Medical Technologies Co., Ltd.: 2 (https://510kreport.com/company/wuxi-hisky-medical-technologies)
- Supersonic Imagine: 2 (https://510kreport.com/company/supersonic-imagine)
- E-Scopics: 2 (https://510kreport.com/company/e-scopics)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Eieling Technology Limited: 1 (https://510kreport.com/company/eieling-technology)
- Esaote, S.p.A.: 1 (https://510kreport.com/company/esaote)
- Sonic Incytes: 1 (https://510kreport.com/company/sonic-incytes)

## Its most-cited devices
- K160524: FibroScan 530 Compact (2016), cited by 6
- K123806: Fibroscan (2013), cited by 3
- K203273: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) (2021), cited by 3
- K181547: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (2018), cited by 3
- K212035: FibroScan 230 (2021), cited by 2
- K150239: FibroScan (2015), cited by 2

## Recent decisions
- K223902: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) (Mar 2, 2023)
- K212035: FibroScan 230 (Jul 30, 2021)
- K203273: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) (Mar 25, 2021)
- K200655: FibroScan® 630 (Jul 16, 2020)
- K181547: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (Jul 9, 2018)
- K173034: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) (Nov 14, 2017)
- K172142: FibroScan 430 Mini+ (Sep 13, 2017)
- K160524: FibroScan 530 Compact (Mar 18, 2016)

Source page: https://510kreport.com/company/echosens