Cleared Special

DIAMOND-5A/6A/8A

K202156 · DRGEM Corporation · Radiology
Sep 2020
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K202156 is an FDA 510(k) clearance for the DIAMOND-5A/6A/8A, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by DRGEM Corporation (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on September 10, 2020, 45 days after receiving the submission on July 27, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K202156 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2020
Decision Date September 10, 2020
Days to Decision 45 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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