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U.S. Department of Health and Human Services

Product Classification

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Device chest x-ray computer aided detection
Regulation Description Medical image management and processing system.
Definition To assist radiologists in the review of chest radiographic images and highlight potential nodules that the radiologist should review.
Physical State Software device.
Technical Method Detection algorithm searches for and identifies potential nodules on images of the chest acquired using x-ray.
Target Area Chest
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeOMJ
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.2050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible