Cleared Traditional

K170540 - DM-Density

K170540 is the FDA 510(k) clearance for DM-Density by Densitas, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K170540 · Densitas, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
365d
Days
Class 2
Risk

K170540 is an FDA 510(k) clearance for the DM-Density. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Densitas, Inc. (Halifax, CA). The FDA issued a Cleared decision on February 23, 2018 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Densitas, Inc. devices

Submission Details

510(k) Number K170540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2017
Decision Date February 23, 2018
Days to Decision 365 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 107d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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

Emergogroup, Inc.
Ken Pilgrim

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 - LLZ System, Image Processing, Radiological

All 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K170540.
icobrain
K180326 · Icometrix · Mar 2018
ProBx Software
K173312 · Harmonus, Inc. · Mar 2018
CereMetrix Silver
K173145 · Ceremetrix Corp · Feb 2018
Ez3D-i /E3
K173863 · Ewoosoft Co., Ltd. · Feb 2018
Velocity
K173636 · Varian Medical Systems, Inc. · Feb 2018
SuRgical Planner (SRP)
K170793 · Surgical Theater, LLC · Feb 2018