Cleared Traditional

K974679 - THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM

K974679 is an FDA 510(k) clearance for THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM, manufactured by Medcon , Ltd.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K974679 · Medcon , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
98d
Days
Class 2
Risk

K974679 is an FDA 510(k) clearance for the THE TCS-MEDCON'S TELECARDIOLOGY SYSTEM. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Medcon , Ltd. (Efrat, IL). The FDA issued a Cleared decision on March 23, 1998 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcon , Ltd. devices

FDA 510(k) Submission Details - K974679

510(k) Number K974679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1997
Decision Date March 23, 1998
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZI System, X-ray, Angiographic

All 142
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K974679.
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
K984545 · Philips Medical Systems North America, Inc. · Feb 1999
PHILIPS INTEGRIS 3D RA OPTION
K983877 · Philips Medical Systems North America, Inc. · Dec 1998
CAAS II LVA BIPLANE OPTION
K982203 · Pie Medical Equipment B.V. · Jul 1998
ADVANTX LCN, ADVANTX LCLP
K974367 · GE Medical Systems · Feb 1998
LEG'MAP OPTION
K973270 · Ge Medical Systems, Inc. · Nov 1997
PHILIPS INTEGRIS V5000 AND BV5000
K973482 · Philips Medical Systems North America, Inc. · Nov 1997