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U.S. Department of Health and Human Services

Product Classification
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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).
Physical State Medical imaging system with AI/ML software
Technical Method AI/ML software analyzes Optical Coherence Tomography (OCT) images of breast tissue and displays areas suspicious for breast cancer for review by the surgeon
Target Area Breast tissue
Review Panel General & Plastic Surgery
Product CodeSHH
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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