Infraredx, Inc.

Infraredx, Inc. holds 11 FDA 510(k) medical device clearances, first cleared 2006, most recent 2025, with 1 FDA device recall on record.

FDA recalls by Infraredx, Inc.

Z-0940-2017 — TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal viewsClass II·Terminated·2016-12-15

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Infraredx, Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for Infraredx, Inc.

FDA recalls by Infraredx, Inc.

Recent clearances by Infraredx, Inc.