Data / Medical devices / France / Echosens
Echosens: FDA-registered device maker in Paris, France, 8 510(k) clearances
Echosens is registered with the FDA (registration 3010258456) in Paris, France. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 30, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010258456
- Address
- 6 rue Ferrus, Paris, France, 75014
- Owner or operator
- Echosens (10043955)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 11, 2013
- Registered through
- 2026
- Brand names listed
- Agile 3+ Calculator, Agile 4 Calculator, Fast Calculator, FibroScan, FibroScan 230, FibroScan 430 Mini+, FibroScan 502 Touch, FibroScan 630 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 30, 2021 | K212035 | FibroScan 230 | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
| July 16, 2020 | K200655 | FibroScan® 630 | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
| July 9, 2018 | K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
| September 13, 2017 | K172142 | FibroScan 430 Mini+ | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
| March 18, 2016 | K160524 | FibroScan 530 Compact | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
| September 1, 2015 | K150239 | FibroScan | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
| June 3, 2015 | K150949 | FibroScan | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
| April 5, 2013 | K123806 | FIBROSCAN | IYO | Substantially Equivalent | Echosens | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Medical Device Data System
Updated July 30, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.