Cleared Abbreviated

K060035 - MDXNET

K060035 is an FDA 510(k) clearance for MDXNET, manufactured by Cybermdx, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K060035 · Cybermdx, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
63d
Days
Class 2
Risk

K060035 is an FDA 510(k) clearance for the MDXNET. 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 Cybermdx, Inc. (Providence, US). The FDA issued a Cleared decision on March 9, 2006 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Incremental AI imaging tool. Standards-verified equivalence. 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.

FDA 510(k) Submission Details - K060035

510(k) Number K060035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2006
Decision Date March 09, 2006
Days to Decision 63 days
Submission Type Abbreviated
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
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

LLZ Device Classification - Class 2, Special Controls

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 Peers - LLZ System, Image Processing, Radiological

All 2284
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K060035.
M-VU VIEWER STATION
K060451 · Vucomp, Inc. · Mar 2006
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
K060267 · Implant Logic Systems, Ltd. · Mar 2006
IQPACS
K060263 · S.C. Info World S.R.L. · Mar 2006
VITREA2 VERSION 3.8.1
K060378 · Vital Images, Inc. · Mar 2006
AZE VIRTUALPLACE
K060453 · Aze, Ltd. · Mar 2006
CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF
K053039 · Clinton Electronics Corp. · Mar 2006
K060035 · MDXNET
Download PDF FDA Summary Cybermdx, Inc.