Cleared Traditional

SAMSUNG RAYPAX DISPLAY WORKSTATION

K992306 · Samsung Sds Co., Ltd. · Radiology
Sep 1999
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K992306 is an FDA 510(k) clearance for the SAMSUNG RAYPAX DISPLAY WORKSTATION, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on September 22, 1999, 75 days after receiving the submission on July 9, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K992306 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 1999
Decision Date September 22, 1999
Days to Decision 75 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