Medical Device Manufacturer · US , Pleasant Hill , CA

Terarecon,Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1998

Total

Cleared

Denied

Terarecon,Inc. has 14 FDA 510(k) cleared radiology devices. Based in Pleasant Hill, US.

Latest FDA clearance: Oct 2025. Active since 1998.

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

FDA 510(k) Regulatory Record - Terarecon,Inc.

14 devices

1-14 of 14

Cleared Oct 23, 2025

TeraRecon Cardiovascular.Calcification.CT

K250288 · QIH

Radiology · 265d

Cleared Jan 23, 2025

TeraRecon Aorta.CT (1.1.0)

K243158 · QIH

Radiology · 115d

Cleared Nov 05, 2024

TeraRecon Cardiac.Chambers.MR (1.0.0)

iNtuition-Structural Heart Module

K191585 · LLZ

Radiology · 28d

Cleared Sep 24, 2018

iNtuition-T1 Mapping and T2/T2* Mapping

K180916 · LLZ

Radiology · 168d

Cleared Dec 24, 2013

INTUITION - TDA, TVA, PARAMETRIC MAPPING

IIVS INTEGRATED IMAGE VIEWING STATION

Terarecon,Inc. - FDA 510(k) Cleared Devices

Filters