Cleared Traditional

CEREBROVASCULAR DIAGNOSTIC SYSTEM (K914862) - FDA 510(k) Clearance

Also marketed or referenced as:
CDS

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

K914862 · Medasonics, Inc. · Radiology device
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Dec 1992
Decision
401d
Days
Class 2
Risk

K914862 is an FDA 510(k) clearance for the CEREBROVASCULAR DIAGNOSTIC SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Medasonics, Inc. (Fremont, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Medasonics, Inc. devices

Submission Details

510(k) Number K914862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date December 03, 1992
Days to Decision 401 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
294d slower than avg
Panel avg: 107d · This submission: 401d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K914862.
HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION
K934041 · Hewlett-Packard Co. · Sep 1994
VENUS DIAGNOSTIC ULTRASOUND SYSTEM
K933202 · GE Medical Systems · Jun 1994
SSH-140A FETAL DOPPLER SYSTEM
K931293 · Toshiba America Medical Systems, In.C · Feb 1994
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984
DOPPLER IMAGING OPTION
K840140 · Hewlett-Packard Co. · Aug 1984