Cleared Traditional

K800768 - VASCULAB BI-DIRECTIONAL DOPPLER, #D10 (FDA 510(k) Clearance)

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

K800768 · Medasonics, Inc. · Radiology device
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Jul 1980
Decision
92d
Days
Class 2
Risk

K800768 is an FDA 510(k) clearance for the VASCULAB BI-DIRECTIONAL DOPPLER, #D10. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Medasonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - 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 Medasonics, Inc. devices

Submission Details

510(k) Number K800768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date July 08, 1980
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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.