Post-Ablation Tissue Response Prediction Software

QZL · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2052

Classification

FDA Product Code: QZL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.2052
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown