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Post-Ablation Tissue Response Prediction Software

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2052
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QZL is linked to regulation 21CFR892.2052, which does not seem to exist yet. It may be pending at the moment.

Post-Ablation Tissue Response Prediction Software

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2052
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QZL is linked to regulation 21CFR892.2052, which does not seem to exist yet. It may be pending at the moment.