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U.S. Department of Health and Human Services

Product Classification
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Device computer-assisted diagnostic software for lesions suspicious for cancer
Regulation Description Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
Definition Assist users in characterizing lesions identified on acquired medical images
Physical State Software
Technical Method The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user.
Target Area Lesions
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodePOK
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.2060
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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