Cleared Traditional

K073007 - CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL

K073007 is an FDA 510(k) clearance for CORONIS FUSION 6MP DL, 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 113-day FDA review.

K073007 · Barcoview, Medical Imaging Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
113d
Days
Class 2
Risk

K073007 is an FDA 510(k) clearance for the CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL. 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 February 14, 2008 after a review of 113 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 - K073007

510(k) Number K073007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2007
Decision Date February 14, 2008
Days to Decision 113 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
6d slower than avg
Panel avg: 107d · This submission: 113d
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 K073007.
SYNGO IMAGING CCF VA10A
K073418 · Siemens AG Medical Solutions · Feb 2008
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