Cleared Traditional

K052352 - COLOR CORONIS 2MP-21 AND MFCD 2321

K052352 is an FDA 510(k) clearance for COLOR CORONIS 2MP-21 AND MFCD 2321, manufactured by Barcoview. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K052352 · Barcoview · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
32d
Days
Class 2
Risk

K052352 is an FDA 510(k) clearance for the COLOR CORONIS 2MP-21 AND MFCD 2321. 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 30, 2005 after a review of 32 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 - K052352

510(k) Number K052352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date September 30, 2005
Days to Decision 32 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
75d faster than avg
Panel avg: 107d · This submission: 32d
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 K052352.
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
K052775 · Siemens AG Medical Solutions · Oct 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · Siemens Medical Solutions USA, Inc. · Oct 2005
WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
K052312 · Wide Corporation · Oct 2005
E-2320 PA S
K052529 · Barcoview · Sep 2005
MFCD 1219, MFCD 1219 TS
K052478 · Barcoview · Sep 2005
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
K052199 · Totoku Electric Co., Ltd. · Sep 2005