Cleared Special

K130395 - STEREOS WORKSTATION

K130395 is an FDA 510(k) clearance for STEREOS WORKSTATION, manufactured by Eos Imaging, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 24-day FDA review.

K130395 · Eos Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
24d
Days
Class 2
Risk

K130395 is an FDA 510(k) clearance for the STEREOS WORKSTATION. 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 Eos Imaging, Inc. (Washington, US). The FDA issued a Cleared decision on March 11, 2013 after a review of 24 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 - K130395

510(k) Number K130395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2013
Decision Date March 11, 2013
Days to Decision 24 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
83d faster than avg
Panel avg: 107d · This submission: 24d
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 2233
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K130395.
SUITEHEART
K130228 · Neosoft, LLC · Mar 2013
MIRADA RTX
K130393 · Mirada Medical, Ltd. · Mar 2013
RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31
K123186 · Calgary Scientific, Inc. · Mar 2013
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
K123426 · Orpheus Medical , Ltd. · Mar 2013
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
K122578 · Vital Images, Inc. · Feb 2013
ARIX RAD ACQUISITION CONSOLE
K123650 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Feb 2013