Cleared Traditional

K992666 - VIDEO PLUS SYSTEM, SERIES 95000

K992666 is an FDA 510(k) clearance for VIDEO PLUS SYSTEM, manufactured by Camtronics, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K992666 · Camtronics, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
65d
Days
Class 2
Risk

K992666 is an FDA 510(k) clearance for the VIDEO PLUS SYSTEM, SERIES 95000. 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 Camtronics, Ltd. (Hartland, US). The FDA issued a Cleared decision on October 13, 1999 after a review of 65 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 - K992666

510(k) Number K992666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date October 13, 1999
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 2257
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K992666.
AX WORKSTATION DR-VIEWER SOFTWARE OPTION
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PLUG 'N VIEW 3D, VERSION 1.0
K992654 · Voxar Limited · Nov 1999
SNT IMAGE ANALYSIS SYSTEM
K992354 · Surgical Navigation Technologies, Inc. · Oct 1999
CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000
K992575 · Infimed, Inc. · Oct 1999
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP
K990241 · Accuimage Diagnostics Corp. · Sep 1999
K992666 · VIDEO PLUS SYSTEM, SERIES 95000
Download PDF FDA Summary Camtronics, Ltd.