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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, quality-assurance, radiologic
Regulation Description Radiologic quality assurance instrument.
Product CodeLHO
Regulation Number 892.1940
Device Class 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Landauer II Mar-21-2024
2 Mevion Medical Systems, Inc. II Jul-22-2020
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