Cleared Traditional

K992378 - DIAGNOSTIC ULTRASOUND, MODEL 1.0

K992378 is an FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND, manufactured by Volumetrics Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K992378 · Volumetrics Medical Imaging, Inc. · Radiology device
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Sep 1999
Decision
75d
Days
Class 2
Risk

K992378 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND, MODEL 1.0. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Volumetrics Medical Imaging, Inc. (Durham, US). The FDA issued a Cleared decision on September 29, 1999 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Volumetrics Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K992378

510(k) Number K992378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1999
Decision Date September 29, 1999
Days to Decision 75 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 107d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 635
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