Medical Device Manufacturer · US , Dedham , MA

Echosens - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2013

Recent clearances: FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630), FibroScan 230, FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

Total

Cleared

Denied

Echosens has 11 FDA 510(k) cleared radiology devices. Based in Dedham, US.

Last cleared in 2023. Active since 2013.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Boston Medtech Advisors, Inc. as regulatory consultant.

Echosens is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Echosens

11 devices

1-11 of 11

Cleared Mar 02, 2023

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

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

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

K181547 · IYO

Radiology · 27d

Cleared Nov 14, 2017

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

FibroScan 530 Compact

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 14, 2026

Echosens - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Echosens

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