Cleared Traditional

TEC 2720 MAMEX DC MAG (K854203) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 18
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K854203.
MAMMOMAT C
K890784 · Siemens Medical Solutions USA, Inc. · May 1989
BREAST LESION LOCALIZATION NEEDLE
K881697 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · General Electric Co. · May 1988
ISO-MAMMO
K860129 · Philips Medical Systems (Cleveland), Inc. · Mar 1986