Cleared Special

DIAMOND-5A/6A/8A

K192453 · DRGEM Corporation · Radiology
Oct 2019
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K192453 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 October 1, 2019, 22 days after receiving the submission on September 9, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K192453 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2019
Decision Date October 01, 2019
Days to Decision 22 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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