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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluorescence imaging for breast cancer detection
Definition The combination product consists of an optical imaging agent for injection, and a fluorescence imaging device. The product is intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The imaging device is used with the imaging drug for fluorescence imaging of the lumpectomy cavity.
Product CodeSAW
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 3 2 0

Recalls
Manufacturer Recall Class Date Posted
1 Lumicell, Inc. II Sep-04-2025
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