Cleared Traditional

K070606 - VISIO+CD VIEWER# KPSCDVE01

K070606 is an FDA 510(k) clearance for VISIO+CD VIEWER# KPSCDVE01, manufactured by Keosys Sas. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K070606 · Keosys Sas · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
50d
Days
Class 2
Risk

K070606 is an FDA 510(k) clearance for the VISIO+CD VIEWER# KPSCDVE01. 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 Keosys Sas (Saint-Herblain, FR). The FDA issued a Cleared decision on April 24, 2007 after a review of 50 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.

FDA 510(k) Submission Details - K070606

510(k) Number K070606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2007
Decision Date April 24, 2007
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
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 2229
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K070606.
NIO COLOR 3MP AND MDNC 3120
K070726 · Barcoview, Medical Imaging Systems · May 2007
SAPHENEIA CLARITY
K063391 · Sapheneia Commercial Products AB · Apr 2007
DICOMPACS, MODEL 5
K070618 · Oehm Und Rehbein GmbH · Apr 2007
PATIENTGALLERY IMAGING SOFTWARE
K070954 · Raster Builders, Inc. · Apr 2007
DGSCOPE, RELEASE 1.0
K070397 · Segami Corporation · Apr 2007
MIRAGE CEDARS OPTION
K070683 · Segami Corporation · Apr 2007