Cleared Traditional

K062621 - NIO 5MP-21 AND MDNG-5121 CB

K062621 is an FDA 510(k) clearance for NIO 5MP-21 AND MDNG-5121 CB, manufactured by Barcoview. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K062621 · Barcoview · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
195d
Days
Class 2
Risk

K062621 is an FDA 510(k) clearance for the NIO 5MP-21 AND MDNG-5121 CB. 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 (Kortrijk, BE). The FDA issued a Cleared decision on March 19, 2007 after a review of 195 days - an extended review cycle.

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 - K062621

510(k) Number K062621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date March 19, 2007
Days to Decision 195 days
Submission Type Traditional
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
88d slower than avg
Panel avg: 107d · This submission: 195d
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 2241
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