Cleared Traditional

K941979 - VIDEO PLUS WITH ANALYTICAL WORKSTATION (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941979 · Camtronics, Ltd. · Radiology device
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Aug 1994
Decision
114d
Days
Class 2
Risk

K941979 is an FDA 510(k) clearance for the VIDEO PLUS WITH ANALYTICAL WORKSTATION. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Camtronics, Ltd. (Hartland, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Camtronics, Ltd. devices

Submission Details

510(k) Number K941979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date August 17, 1994
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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.

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