Cleared Traditional

SAMSUNG RAYPAX LONG TERM ARCHIVE

K992131 · Samsung Sds Co., Ltd. · Radiology

Sep 1999

Decision

82d

Days

Class 1

Risk

About This 510(k) Submission

K992131 is an FDA 510(k) clearance for the SAMSUNG RAYPAX LONG TERM ARCHIVE, a Device, Digital Image Storage, Radiological (Class I — General Controls, product code LMB), submitted by Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on September 13, 1999, 82 days after receiving the submission on June 23, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2010.

Submission Details

510(k) Number	K992131 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 1999
Decision Date	September 13, 1999
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	LMB — Device, Digital Image Storage, Radiological
Device Class	Class I — General Controls
CFR Regulation	21 CFR 892.2010
Definition	Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.