Cleared Traditional

RADMAX Digital Imaging Software

K182537 · DRGEM Corporation · Radiology
Mar 2019
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K182537 is an FDA 510(k) clearance for the RADMAX Digital Imaging Software, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by DRGEM Corporation (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on March 8, 2019, 175 days after receiving the submission on September 14, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K182537 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2018
Decision Date March 08, 2019
Days to Decision 175 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