Device Recall Infraredx

  • Model / Serial
    Serial Numbers: MC9-15013, MC9-15006, MC9-15005, MC9-15008, MC9-15012, MC9-15007 and 12718M00009 (spare laser assembly)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including MI and Internationally to South Korea
  • Product Description
    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 views
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Infraredx, Inc., 34 3rd Ave, Burlington MA 01803-4414
  • Manufacturer Parent Company (2017)
  • Source
    USFDA