Cleared Special

K133609 - THE DOME S6C

K133609 is an FDA 510(k) clearance for THE DOME S6C, 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 95-day FDA review.

K133609 · Nds Surgical Imaging · Radiology device
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Feb 2014
Decision
95d
Days
Class 2
Risk

K133609 is an FDA 510(k) clearance for the THE DOME S6C. 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 February 28, 2014 after a review of 95 days - within the typical 510(k) review window.

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. Moderate 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 Nds Surgical Imaging devices

FDA 510(k) Submission Details - K133609

510(k) Number K133609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date February 28, 2014
Days to Decision 95 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
12d faster than avg
Panel avg: 107d · This submission: 95d
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
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