Cleared Traditional

SAMSUNG RAYPAX FILM DIGITIZER

K992112 · Samsung Sds Co., Ltd. · Radiology
Sep 1999
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K992112 is an FDA 510(k) clearance for the SAMSUNG RAYPAX FILM DIGITIZER, 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 9, 1999, 79 days after receiving the submission on June 22, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K992112 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1999
Decision Date September 09, 1999
Days to Decision 79 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