510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K243084Substantially Equivalent

BioTraceIO Precision (2.0)

Techsomed Medical Technologies, Ltd., Rehovot, IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243084 is the FDA 510(k) clearance record for BioTraceIO Precision (2.0), a class II device, cleared for Techsomed Medical Technologies , Ltd. on under FDA product code QZL (Post-Ablation Tissue Response Prediction Software). FDA's definition for product code QZL reads: "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...". FDA records list 3 510(k) clearances for Techsomed Medical Technologies , Ltd., from to . As of , FDA records show no recalls naming K243084.

Clearance record

Decision date
Received
(88 days to decision)
Product code
QZL Post-Ablation Tissue Response Prediction Software
Regulation
21 CFR 892.2052
Device class
Class II
Review panel
Radiology
Applicant
Techsomed Medical Technologies , Ltd. Meir Weisgal 2, Rehovot, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QZL

Trailing 12 months

FDA records hold no clearances under product code QZL in the trailing twelve months.

FDA records show no clearances under product code QZL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260