Cleared Traditional

K840140 - DOPPLER IMAGING OPTION

K840140 is the FDA 510(k) clearance for DOPPLER IMAGING OPTION by Hewlett-Packard Co.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K840140 · Hewlett-Packard Co. · Radiology device
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Aug 1984
Decision
232d
Days
Class 2
Risk

K840140 is an FDA 510(k) clearance for the DOPPLER IMAGING OPTION. 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 Hewlett-Packard Co. (Walker, US). The FDA issued a Cleared decision on August 23, 1984 after a review of 232 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K840140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date August 23, 1984
Days to Decision 232 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
125d slower than avg
Panel avg: 107d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 793
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K840140.
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · General Electric Co. · Feb 1985
AUTO DII MULTI FREQUENCY
K844293 · Technicare Corp. · Feb 1985
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · Philips Medical Systems (Cleveland), Inc. · Aug 1984
ACCESS SCANHEADSS
K840953 · Advanced Technology Laboratories, Inc. · Jun 1984
LS1000 ELECTRONIC FOCUS
K810118 · Philips Medical Systems (Cleveland), Inc. · Feb 1981
DIASONICS SMALL PARTS SCANNER
K802979 · Diasonics, Inc. · Jan 1981