Atlas FDA

QZL

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Post-Ablation Tissue Response Prediction Software
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2052
Medical specialty
Radiology
FDA 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.
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RecordFirmDate
BioTraceIO Precision (2.0) (K243084)Techsomed Medical Technologies , Ltd.2024-12-27
BioTraceIO Lite (DEN230020)Techsomed Medical Technologies , Ltd.2023-12-22

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Every clearance here is in the API, with alerts when new ones post.