Cleared Traditional

ID. STORE (RELEASE 2.0)

K973413 · I.S.G. Technologies, Inc. · Radiology

Nov 1997

Decision

77d

Days

Class 1

Risk

About This 510(k) Submission

K973413 is an FDA 510(k) clearance for the ID. STORE (RELEASE 2.0), a Device, Digital Image Storage, Radiological (Class I — General Controls, product code LMB), submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on November 25, 1997, 77 days after receiving the submission on September 9, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2010.

Submission Details

510(k) Number	K973413 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 1997
Decision Date	November 25, 1997
Days to Decision	77 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.