Cleared Special

VisAble.IO

K240773 · Techsomed · Radiology
Apr 2024
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K240773 is an FDA 510(k) clearance for the VisAble.IO, a Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (Class II — Special Controls, product code QTZ), submitted by Techsomed (Rehovot, IL). The FDA issued a Cleared decision on April 15, 2024, 25 days after receiving the submission on March 21, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K240773 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2024
Decision Date April 15, 2024
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QTZ — Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy.