Not Cleared Post-NSE

DEN020001 - BREASTVIEW VISUAL MAPPING SYSTEM (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN020001 · Assurance Medical · Obstetrics & Gynecology device
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Jan 2003
Decision
248d
Days
Class 2
Risk

DEN020001 is an FDA 510(k) submission (not cleared) for the BREASTVIEW VISUAL MAPPING SYSTEM. Classified as System, Documentation, Breast Lesion (product code NKA), Class II - Special Controls.

Submitted by Assurance Medical (Washington, US). The FDA issued a Not Cleared (DENG) decision on January 31, 2003 after a review of 248 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2990 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Obstetrics & Gynecology review framework.

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Submission Details

510(k) Number DEN020001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 28, 2002
Decision Date January 31, 2003
Days to Decision 248 days
Submission Type Post-NSE
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 160d · This submission: 248d
Pathway characteristics

Device Classification

Product Code NKA System, Documentation, Breast Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2990
Definition A Breast Lesion Documentation Device Is A Device For Recording And Documenting Palpable Breast Lesions Detected During A Clinical Breast Exam.
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 Obstetrics & Gynecology devices follow this clearance model.