Post-Ablation Tissue Response Prediction Software
The post-ablation tissue response prediction software (product code QZL) is a Class 2 Radiology image processing device (regulation 892.2052) intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure, using information extracted from medical images and other clinical data to predict the ablation zone post-treatment. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QZL
- Device Class
- FDA class 2
- Regulation Number
- 892.2052
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.