Cleared Traditional

K871048 - MICRO MAMMO I MAMMOGRAPHY UNIT (FDA 510(k) Clearance)

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

K871048 · Amerasia Import-Export, Inc. · Radiology device
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Sep 1987
Decision
168d
Days
Class 2
Risk

K871048 is an FDA 510(k) clearance for the MICRO MAMMO I MAMMOGRAPHY UNIT. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Amerasia Import-Export, Inc. (Reno, US). The FDA issued a Cleared decision on September 1, 1987 after a review of 168 days - an extended review cycle.

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 Amerasia Import-Export, Inc. devices

Submission Details

510(k) Number K871048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date September 01, 1987
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
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.