Cleared Traditional

K062141 - MAMMOPAD RADIOLUCENT CUSHION (FDA 510(k) Clearance)

Class I Radiology device.

K062141 · Biolucent, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
48d
Days
Class 1
Risk

K062141 is an FDA 510(k) clearance for the MAMMOPAD RADIOLUCENT CUSHION. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Biolucent, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on September 13, 2006 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biolucent, Inc. devices

Submission Details

510(k) Number K062141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2006
Decision Date September 13, 2006
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.