Cleared Traditional

K223639 - VisAble.IO (FDA 510(k) Clearance)

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

K223639 · Techsomed · Radiology device
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Aug 2023
Decision
266d
Days
Class 2
Risk

K223639 is an FDA 510(k) clearance for the VisAble.IO. Classified as Radiological Image Processing Software For Ablation Therapy Planning And Evaluation (product code QTZ), Class II - Special Controls.

Submitted by Techsomed (Rehovot, IL). The FDA issued a Cleared decision on August 28, 2023 after a review of 266 days - an extended review cycle.

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. Standard predicate reliance. 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 Techsomed devices

Submission Details

510(k) Number K223639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2022
Decision Date August 28, 2023
Days to Decision 266 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
159d slower than avg
Panel avg: 107d · This submission: 266d
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 Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

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