Cleared Traditional

K861109 - CW DOPPLER STATIC TRANSDUCERS

K861109 is an FDA 510(k) clearance for CW DOPPLER STATIC TRANSDUCERS, manufactured by Advanced Technology Laboratories, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K861109 · Advanced Technology Laboratories, Inc. · Radiology device
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Jul 1986
Decision
105d
Days
Class 2
Risk

K861109 is an FDA 510(k) clearance for the CW DOPPLER STATIC TRANSDUCERS. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Bothell, US). The FDA issued a Cleared decision on July 8, 1986 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Advanced Technology Laboratories, Inc. devices

FDA 510(k) Submission Details - K861109

510(k) Number K861109 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 25, 1986
Decision Date July 08, 1986
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 345
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K861109.
PS SYSTEM WITH SD-200 DOPPLER
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SDL-300
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STORZ, ALPHA II BIOMETRIC RULER
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