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U.S. Department of Health and Human Services

Product Classification
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Device post-ablation tissue response prediction software
Definition A Post-ablation tissue response prediction software is an image processing device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment.
Physical State Software device
Technical Method Medical images are analyzed for prediction of ablation zone post treatment.
Target Area The device operates on radiological images of the human body.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQZL
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.2052
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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