Cleared Special

K243084 - BioTraceIO Precision (2.0) (FDA 510(k) Clearance)

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

K243084 · Techsomed Medical Technologies , Ltd. · Radiology device
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Dec 2024
Decision
88d
Days
Class 2
Risk

K243084 is an FDA 510(k) clearance for the BioTraceIO Precision (2.0). Classified as Post-ablation Tissue Response Prediction Software (product code QZL), Class II - Special Controls.

Submitted by Techsomed Medical Technologies , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on December 27, 2024 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2052 - 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 Medical Technologies , Ltd. devices

Submission Details

510(k) Number K243084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date December 27, 2024
Days to Decision 88 days
Submission Type Special
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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QZL Post-ablation Tissue Response Prediction Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2052
Definition A Post-ablation Tissue Response Prediction Software Is An Image Processing Device Intended To Aid Physicians With Adjunctive Information In Their Clinical Assessment Of The Ablation Zone Following A Tissue Ablation Procedure. This Device Uses Information Extracted From Medical Images Along With Other Clinical Data To Predict The Ablation Zone Post Treatment.
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.