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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device digital image, storage and communications, non-diagnostic, laboratory information system
Regulation Description Calculator/data processing module for clinical use.
Definition Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.
Product CodeNVV
Regulation Number 862.2100
Device Class 1

Device Problems
Loss of Data 1
Programming issue 1
Data Issue 1
Total Device Problems 3

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