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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZH System, X-ray, Mammographic

All 165
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K071787.
EMBRACE
K101373 · Izi Medical Products, Inc. · Sep 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · Hologic, Inc. · Apr 2010
BELLA
K073262 · Beekley Corp. · Mar 2008
DIGITAL STEREOLOC II
K071542 · Lorad, A Hologic Co. · Jul 2007
LIV BREAST SELF EXAMINATION AID
K070344 · Liv International USA, Inc. · Mar 2007
BIOPSY DIGIT-AM
K062039 · Giotto USA, LLC · Sep 2006
K071787 · BEMITT, MODEL 0001
Download PDF FDA Summary Dja Distributors, LLC