Cleared Traditional

K071787 - BEMITT, MODEL 0001

K071787 is an FDA 510(k) clearance for BEMITT, manufactured by Dja Distributors, LLC. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K071787 · Dja Distributors, LLC · Radiology device
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Oct 2007
Decision
116d
Days
Class 2
Risk

K071787 is an FDA 510(k) clearance for the BEMITT, MODEL 0001. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Dja Distributors, LLC (Las Vegas, US). The FDA issued a Cleared decision on October 26, 2007 after a review of 116 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 Dja Distributors, LLC devices

FDA 510(k) Submission Details - K071787

510(k) Number K071787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date October 26, 2007
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 95
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K071787.
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PLANMED SOPHIE NUANCE CLASSIC
K042671 · Planmed OY · Nov 2004
MAMMOTEST
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LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · Hologic, Inc. · Apr 2004