Cleared Traditional

K890998 - QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.

K890998 is an FDA 510(k) clearance for QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DO..., manufactured by Quantum Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K890998 · Quantum Medical Systems, Inc. · Radiology device
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May 1989
Decision
88d
Days
Class 2
Risk

K890998 is an FDA 510(k) clearance for the QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.. 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 Quantum Medical Systems, Inc. (Issaquah, US). The FDA issued a Cleared decision on May 2, 1989 after a review of 88 days - a notably fast clearance cycle.

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: 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 Quantum Medical Systems, Inc. devices

FDA 510(k) Submission Details - K890998

510(k) Number K890998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1989
Decision Date May 02, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 1144
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K890998.
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CAVROLAB
K882585 · Life-Tech Intl., Inc. · Mar 1989
ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER
K882737 · Acuson Corp. · Sep 1988
5 MHZ DOPPLER OUTRIGGER
K872817 · Philips Ultrasound, Inc. · Feb 1988