Cleared Traditional

Mendaera Guidance System

K250524 · Mendaera, Inc. · Radiology

Jul 2025

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K250524 is an FDA 510(k) clearance for the Mendaera Guidance System, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Mendaera, Inc. (San Mateo, US). The FDA issued a Cleared decision on July 2, 2025, 131 days after receiving the submission on February 21, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K250524 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2025
Decision Date	July 02, 2025
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF