Cleared Traditional

K051586 - VIEWSEND MEDICAL SYSTEM

K051586 is an FDA 510(k) clearance for VIEWSEND MEDICAL SYSTEM, manufactured by Kenei Co., Ltd.. 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.

K051586 · Kenei Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
50d
Days
Class 2
Risk

K051586 is an FDA 510(k) clearance for the VIEWSEND MEDICAL SYSTEM. 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 Kenei Co., Ltd. (Mclean, US). The FDA issued a Cleared decision on August 4, 2005 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 - K051586

510(k) Number K051586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2005
Decision Date August 04, 2005
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 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K051586.
ULTRAPACS
K051813 · Ultrarad Corporation · Aug 2005
ENSITE VERISMO SOFTWARE
K051840 · St Jude Medical · Aug 2005
NIO 2MP-21
K051902 · Barcoview · Aug 2005
AS-OBGYN INFORMATION SYSTEM
K051639 · As Software, Inc. · Aug 2005
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
K051649 · Camtronics Medical Systems · Aug 2005
STARPACS DENTAL
K051715 · Infinitt Co., Ltd. · Aug 2005
K051586 · VIEWSEND MEDICAL SYSTEM
Download PDF FDA Summary Kenei Co., Ltd.