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)
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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.

View all Nds Surgical Imaging devices

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
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 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K120709.
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