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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, x-ray, intraoral
Regulation Description Intraoral source x-ray system.
Product CodeEAP
Regulation Number 872.1810
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 12 12
2025 1 1
2026 259 259

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 192 192
Communication or Transmission Problem 41 41
Failure to Transmit Record 38 38
Patient Data Problem 13 13
Intermittent Communication Failure 13 13
Image Display Error/Artifact 12 12
Failure to Read Input Signal 3 3
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 274 274

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