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U.S. Department of Health and Human Services

Product Classification

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Device image acquisition and/or optimization guided by artificial intelligence
Definition A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
Physical State The subject software would utilize images acquired using an imaging system. The software can be installed on an existing imaging system, or can be operated on a computer that is connected to the imaging system.
Technical Method The device's algorithm would be based on the analysis of images and/or diagnostic data. The underlying algorithms used for providing guidance to the users may be based on deep learning methods, trained on images obtained by trained operators.
Target Area Human body
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQJU
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 892.2100
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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