Cleared Traditional

K222938 - Ablation-fit (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222938 · R.A.W. S.R.L · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
351d
Days
Class 2
Risk

K222938 is an FDA 510(k) clearance for the Ablation-fit. Classified as Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (product code QTZ), Class II - Special Controls.

Submitted by R.A.W. S.R.L (Milan, IT). The FDA issued a Cleared decision on September 12, 2023 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all R.A.W. S.R.L devices

Submission Details

510(k) Number K222938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 107d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

Devices cleared under the same product code (QTZ) and FDA review panel - the closest regulatory comparables to K222938.
BioTraceIO Vision (V1.7)
K251931 · Techsomed Medical Technologies · Sep 2025
myAblation Guide (VB80A)
K240796 · Siemens Healthcare GmbH · Aug 2024
VisAble.IO
K240773 · Techsomed · Apr 2024
Artemis, Artemis TPO, Artemis MX
K222222 · Eigen · Oct 2023
VisAble.IO
K223639 · Techsomed · Aug 2023
MIM-Ablation
K220256 · Mim Software, Inc. · Oct 2022