Cleared Traditional

TechLive

K243703 · DeepHealth, Inc. · Radiology
Jun 2025
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K243703 is an FDA 510(k) clearance for the TechLive, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by DeepHealth, Inc. (Somerville, US). The FDA issued a Cleared decision on June 5, 2025, 188 days after receiving the submission on November 29, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K243703 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2024
Decision Date June 05, 2025
Days to Decision 188 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050