Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device x-ray angiographic imaging based coronary vascular simulation software device
Regulation Description Angiographic x-ray system.
Definition X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.
Product CodeQHA
Regulation Number 892.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTERYFLOW TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
PIE MEDICAL IMAGING BV
  SUBSTANTIALLY EQUIVALENT 1
QFR SOLUTIONS BV
  SUBSTANTIALLY EQUIVALENT 1
SPECTRAWAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-