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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oct imaging system with ai/ml software for adjunctive detection of breast cancer
Definition Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).
Product CodeSHH
Device Class 3

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

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