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U.S. Department of Health and Human Services

Product Classification
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Device radiology software for referral of findings related to fibrotic lung disease.
Definition Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
Physical State Software application and/or firmware, system components and accessories
Technical Method Processing radiographic data to assist in the subtyping of ILDs.
Target Area Human-derived CT imaging products
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQWO
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.2085
Device Class 2
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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