Cleared Special

K240773 - VisAble.IO (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240773 · Techsomed · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
25d
Days
Class 2
Risk

K240773 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 April 15, 2024 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Techsomed devices

Submission Details

510(k) Number K240773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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

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