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U.S. Department of Health and Human Services

Product Classification

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Device solid state x-ray imager (flat panel/digital imager)
Regulation Description Stationary x-ray system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeMQB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; Final
Third Party Review
Accredited Persons

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