Cleared Traditional

K940172 - CARDIOVASCULAR MEASUREMENT SYSTEM-CMS (FDA 510(k) Clearance)

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

K940172 · Medis Medical Imaging Systems, Inc. · Radiology device
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Sep 1994
Decision
261d
Days
Class 2
Risk

K940172 is an FDA 510(k) clearance for the CARDIOVASCULAR MEASUREMENT SYSTEM-CMS. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Medis Medical Imaging Systems, Inc. (Ridgefield, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 261 days - an extended review cycle.

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 Medis Medical Imaging Systems, Inc. devices

Submission Details

510(k) Number K940172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1994
Decision Date September 29, 1994
Days to Decision 261 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 107d · This submission: 261d
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.

Regulatory Peers - IZI System, X-ray, Angiographic

All 196
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