Cleared Traditional

PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)

K980243 · Parameter Developments, Inc. · Radiology

Apr 1998

Decision

70d

Days

Class 1

Risk

About This 510(k) Submission

K980243 is an FDA 510(k) clearance for the PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS), a Device, Digital Image Storage, Radiological (Class I — General Controls, product code LMB), submitted by Parameter Developments, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 3, 1998, 70 days after receiving the submission on January 23, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2010.

Submission Details

510(k) Number	K980243 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 1998
Decision Date	April 03, 1998
Days to Decision	70 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.