Cleared Traditional

K913674 - RECORD AND VERIFY MEVATRON ADAPTER

K913674 is an FDA 510(k) clearance for RECORD AND VERIFY MEVATRON ADAPTER, manufactured by Computerized Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K913674 · Computerized Medical Systems, Inc. · Radiology device
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Nov 1991
Decision
95d
Days
Class 2
Risk

K913674 is an FDA 510(k) clearance for the RECORD AND VERIFY MEVATRON ADAPTER. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Computerized Medical Systems, Inc. (Maryland Heights, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Computerized Medical Systems, Inc. devices

FDA 510(k) Submission Details - K913674

510(k) Number K913674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date November 22, 1991
Days to Decision 95 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
12d faster than avg
Panel avg: 107d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 332
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K913674.
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