Echosens
Echosens has 0 FDA recalls, 2 inspections, 11 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Feb 2, 2017 · NAI
- Latest 510(k)
- Mar 2, 2023
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 11 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 2, 2017 | Creteil, France | Devices | No Action Indicated (NAI) | 3012038665 |
| Feb 1, 2017 | Paris, France | Devices | Voluntary Action Indicated (VAI) | 3010258456 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| 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 |
| K150239 | FibroScan | Sep 1, 2015 |
| K150949 | FibroScan | Jun 3, 2015 |
| K123806 | FIBROSCAN | Apr 5, 2013 |