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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Barcoview, Medical Imaging Systems devices

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
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 1346
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K072875.
I-DIXEL
K073704 · J. Morita USA, Inc. · Feb 2008
VITREA 4DCT
K072821 · Vital Images, Inc. · Feb 2008
15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2)
K071794 · Totoku Electric Co., Ltd. · Feb 2008
XIDF-100A/B1 IMAGE PROCESSOR
K073259 · Toshiba America Medical Systems, In.C · Dec 2007
COLOR LCD MONITOR, FLEXSCAN MX300W
K073340 · Eizo Nanao Corporation · Dec 2007
INTEGRADWEB PACS SYSTEM
K072986 · Ge Healthcare · Nov 2007