• 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 display, diagnostic radiology
Regulation Description Medical image management and processing system.
Definition The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Physical State Hardware and embedded software
Technical Method Hardware and embedded sofware for displaying radiological images.
Target Area Whole body
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodePGY
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons