Medical Device Manufacturer · US , Dedham , MA

Echosens - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2013

11

Total

11

Cleared

0

Denied

FDA 510(k) cleared devices by Echosens Radiology ✕

11 devices

1-11 of 11

Cleared Mar 02, 2023

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

Radiology · 64d

Cleared Jul 30, 2021

Radiology · 30d

Cleared Mar 25, 2021

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and...

Radiology · 139d

Cleared Jul 16, 2020

FibroScan® 630

Radiology · 126d

Cleared Jul 09, 2018

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

Radiology · 27d

Cleared Nov 14, 2017

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

Radiology · 47d

Cleared Sep 13, 2017

FibroScan 430 Mini+

Radiology · 58d

Cleared Mar 18, 2016

FibroScan 530 Compact

Radiology · 22d

Cleared Sep 01, 2015

Radiology · 211d

Cleared Jun 03, 2015

Radiology · 56d

Cleared Apr 05, 2013

Radiology · 116d