K203273 is an FDA 510(k) clearance for the FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630). This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Echosens (Paris, FR). The FDA issued a Cleared decision on March 25, 2021, 139 days after receiving the submission on November 6, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K203273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2020 |
| Decision Date | March 25, 2021 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |