Cleared Traditional

K903651 - AMI MAMMOSPOT

K903651 is an FDA 510(k) clearance for AMI MAMMOSPOT, manufactured by American Mammographics, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K903651 · American Mammographics, Inc. · Radiology device
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Nov 1990
Decision
97d
Days
Class 2
Risk

K903651 is an FDA 510(k) clearance for the AMI MAMMOSPOT. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by American Mammographics, Inc. (Chattanooga, US). The FDA issued a Cleared decision on November 15, 1990 after a review of 97 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 American Mammographics, Inc. devices

FDA 510(k) Submission Details - K903651

510(k) Number K903651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1990
Decision Date November 15, 1990
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
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 101
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K903651.
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