Cleared Traditional

K052478 - MFCD 1219, MFCD 1219 TS

K052478 is an FDA 510(k) clearance for MFCD 1219, manufactured by Barcoview. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K052478 · Barcoview · Radiology device
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Sep 2005
Decision
19d
Days
Class 2
Risk

K052478 is an FDA 510(k) clearance for the MFCD 1219, MFCD 1219 TS. 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 September 28, 2005 after a review of 19 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. 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 devices

FDA 510(k) Submission Details - K052478

510(k) Number K052478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date September 28, 2005
Days to Decision 19 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 faster than avg
Panel avg: 107d · This submission: 19d
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 1265
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K052478.
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SYNGO IMAGING VERSION V20A
K052461 · Siemens AG Medical Solutions · Sep 2005
NIO 2MP-20 AND E-2620 S
K052276 · Barcoview · Sep 2005