Cleared Traditional

IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM (K992467) - FDA 510(k) Clearance

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

K992467 · Dba Systems, Inc. · Radiology device
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Feb 2000
Decision
202d
Days
Class 2
Risk

K992467 is an FDA 510(k) clearance for the IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM. Classified as Digitizer, Image, Radiological (product code LMA), Class II - Special Controls.

Submitted by Dba Systems, Inc. (Washington, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 202 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2030 - 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 Dba Systems, Inc. devices

Submission Details

510(k) Number K992467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1999
Decision Date February 10, 2000
Days to Decision 202 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 107d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMA Digitizer, Image, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2030
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 - LMA Digitizer, Image, Radiological

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