Cleared Traditional

K072875 - NIO 5MP DISPLAY, MODEL E5620

K072875 is an FDA 510(k) clearance for NIO 5MP DISPLAY, manufactured by Barcoview, Medical Imaging Systems. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K072875 · Barcoview, Medical Imaging Systems · Radiology device
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Jan 2008
Decision
105d
Days
Class 2
Risk

K072875 is an FDA 510(k) clearance for the NIO 5MP DISPLAY, MODEL E5620. 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 Barcoview, Medical Imaging Systems (Kortrijk, BE). The FDA issued a Cleared decision on January 22, 2008 after a review of 105 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.

FDA 510(k) Submission Details - K072875

510(k) Number K072875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date January 22, 2008
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
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 2270
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K072875 · NIO 5MP DISPLAY, MODEL E5620
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