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QZLClass II

Post-Ablation Tissue Response Prediction Software

21 CFR 892.2052 / Radiology
FDA source (opens on fda.gov)

QZL is the FDA product code for Post-Ablation Tissue Response Prediction Software, a class II device type, regulated under 21 CFR 892.2052. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QZL
Device name
Post-Ablation Tissue Response Prediction Software
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.
Regulation
21 CFR 892.2052
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QZL

By decision year
2 clearances under product code QZL with a decision year between 2023 and 2024, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QZL by decision year
YearClearances
20231
20241

Applicants with the most clearances

Product code QZL
Applicants holding the most 510(k) clearances under product code QZL
ApplicantClearances
Techsomed Medical Technologies, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code