Cleared Traditional

Ablation-fit

K222938 · R.A.W. S.R.L · Radiology
Sep 2023
Decision
351d
Days
Class 2
Risk

About This 510(k) Submission

K222938 is an FDA 510(k) clearance for the Ablation-fit, a Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (Class II — Special Controls, product code QTZ), submitted by R.A.W. S.R.L (Milan, IT). The FDA issued a Cleared decision on September 12, 2023, 351 days after receiving the submission on September 26, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K222938 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2022
Decision Date September 12, 2023
Days to Decision 351 days
Submission Type Traditional
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.