Cleared Special

K120709 - THE DOME GX4MP COLOR NONITOR

K120709 is an FDA 510(k) clearance for THE DOME GX4MP COLOR NONITOR, manufactured by Nds Surgical Imaging. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 29-day FDA review.

K120709 · Nds Surgical Imaging · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
29d
Days
Class 2
Risk

K120709 is an FDA 510(k) clearance for the THE DOME GX4MP COLOR NONITOR. 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 Nds Surgical Imaging (San Jose, US). The FDA issued a Cleared decision on April 6, 2012 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 - K120709

510(k) Number K120709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date April 06, 2012
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 2241
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K120709.
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
K120315 · Siemens Medical Solutions USA, Inc. · Apr 2012
MULTI-MODALITY IMAGE FUSION
K120187 · Igt, LLC Dba Eigen · Apr 2012
SYNAPSE 3D BASE TOOLS
K120361 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2012
GE ECHOPAC
K120221 · Ge Healthcare · Mar 2012
VISIA ONCOLOGY
K120484 · Mevis Medical Solutions AG · Mar 2012
ORTHOSIZE
K120115 · Orthosize, LLC · Mar 2012