Cleared Traditional

K842407 - PULSED DOPPLER OPTION, CONTINU-WAVE

K842407 is an FDA 510(k) clearance for PULSED DOPPLER OPTION, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K842407 · General Electric Co. · Radiology device
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Feb 1985
Decision
239d
Days
Class 2
Risk

K842407 is an FDA 510(k) clearance for the PULSED DOPPLER OPTION, CONTINU-WAVE. 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 General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on February 13, 1985 after a review of 239 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 General Electric Co. devices

FDA 510(k) Submission Details - K842407

510(k) Number K842407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date February 13, 1985
Days to Decision 239 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
132d slower than avg
Panel avg: 107d · This submission: 239d
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 1101
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K842407.
TRANSPECT TRANSCRANIAL DOPPLER
K872292 · Medasonics, Inc. · Aug 1987
DOPPLER UNIT, SDS-100A
K863577 · Toshiba Medical Systems · Feb 1987
TECA MF-20 MICROVASCULAR DOPPLER
K850071 · Teca, Inc. · Apr 1985
AUTO DII MULTI FREQUENCY
K844293 · Technicare Corp. · Feb 1985
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984
DOPPLER IMAGING OPTION
K840140 · Hewlett-Packard Co. · Aug 1984