Cleared Traditional

K123426 - MEDICVOD

K123426 is an FDA 510(k) clearance for MEDICVOD, manufactured by Orpheus Medical , Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K123426 · Orpheus Medical , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
114d
Days
Class 2
Risk

K123426 is an FDA 510(k) clearance for the MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS. 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 Orpheus Medical , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on March 1, 2013 after a review of 114 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

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 Orpheus Medical , Ltd. devices

FDA 510(k) Submission Details - K123426

510(k) Number K123426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2012
Decision Date March 01, 2013
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K123426.
INNOVA EPVISION 2.0, INNOVA EPVISION 2.0
K130069 · Ge Healthcare · Apr 2013
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
K130336 · Eizo Nanao Corporation · Mar 2013
NOBELCLINICIAN
K123976 · Nobel Biocare AB · Mar 2013
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
K122578 · Vital Images, Inc. · Feb 2013
4MP COLOR LCD MONITOR, RADIFORCE RX440
K130070 · Eizo Nanao Corporation · Feb 2013
CORONIS FUSION 6MP
K130103 · Barco N.V. · Feb 2013