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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device optoacoustic imaging system
Definition The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis
Product CodeQNK
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 1 0 0 0 0

MDR Year MDR Reports MDR Events
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Mass 1 1

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