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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, beam limiting, x-ray, diagnostic
Regulation Description Diagnostic x-ray beam-limiting device.
Product CodeKPW
Regulation Number 892.1610
Device Class 2


Premarket Reviews
ManufacturerDecision
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Disassembly 1
Detachment of device or device component 1
Total Device Problems 2

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