Cleared Traditional

K973413 - ID. STORE (RELEASE 2.0)

K973413 is an FDA 510(k) clearance for ID. STORE (RELEASE 2.0), manufactured by I.S.G. Technologies, Inc.. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K973413 · I.S.G. Technologies, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
77d
Days
Class 1
Risk

K973413 is an FDA 510(k) clearance for the ID. STORE (RELEASE 2.0). Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on November 25, 1997 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.S.G. Technologies, Inc. devices

FDA 510(k) Submission Details - K973413

510(k) Number K973413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMB Device, Digital Image Storage, Radiological

All 19
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K973413.
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K973463 · O Tech, Inc. · Dec 1997
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
K972380 · Eastman Kodak Company · Sep 1997
TDK MEDICAL GRADE CD-R
K971848 · Tdk Electronics Corporation of America · Aug 1997
WISE IMAGE MANAGEMENT SYSTEM
K971451 · O Tech, Inc. · Jun 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936 · Biosound, Inc. · Mar 1997
UNIVISION ECHOCARDIOLOGY SYSTEM
K964803 · Network Concepts, Inc. · Feb 1997