Cleared Traditional

K854203 - TEC 2720 MAMEX DC MAG

K854203 is an FDA 510(k) clearance for TEC 2720 MAMEX DC MAG, manufactured by Tecnomed, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K854203 · Tecnomed, Inc. · Radiology device
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Mar 1986
Decision
141d
Days
Class 2
Risk

K854203 is an FDA 510(k) clearance for the TEC 2720 MAMEX DC MAG. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Tecnomed, Inc. (Bay Shore, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 Tecnomed, Inc. devices

FDA 510(k) Submission Details - K854203

510(k) Number K854203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1985
Decision Date March 06, 1986
Days to Decision 141 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 107d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 81
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K854203.
ALPHA II DIAGNOSTIC X-RAY
K864958 · Ausonics Pty , Ltd. · Jan 1987
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM
K861692 · Fischer Imaging Corp. · Dec 1986
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710 · Ausonics Pty , Ltd. · Oct 1986
ISO-MAMMO
K860129 · Philips Medical Systems (Cleveland), Inc. · Mar 1986
MINXRAY 500M MAMMOGRAPHIC SYSTEM
K854510 · Minxray, Inc. · Jan 1986
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173 · Ausonics Pty , Ltd. · Apr 1985