• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device endoscope, accessories, image post-processing for color enhancement
Regulation Description Endoscope and accessories.
Definition Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Physical State The system consists of flexible and/or rigid scope(s), light source(s), video processor and display.
Technical Method Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light.
Target Area Limited to endoscopic systems for observation of the gastro-urological tract.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePEA
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.1500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-