Cleared Traditional

K863577 - DOPPLER UNIT

K863577 is an FDA 510(k) clearance for DOPPLER UNIT, manufactured by Toshiba Medical Systems. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K863577 · Toshiba Medical Systems · Radiology device
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Feb 1987
Decision
166d
Days
Class 2
Risk

K863577 is an FDA 510(k) clearance for the DOPPLER UNIT, SDS-100A. 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 Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 166 days - an extended review 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: 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 Toshiba Medical Systems devices

FDA 510(k) Submission Details - K863577

510(k) Number K863577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date February 25, 1987
Days to Decision 166 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 107d · This submission: 166d
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 794
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K863577.
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
TECA MF-20 MICROVASCULAR DOPPLER
K850071 · Teca, Inc. · Apr 1985
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985
AUTO DII MULTI FREQUENCY
K844293 · Technicare Corp. · Feb 1985