Cleared Traditional

K840408 - LINEAR ARRAY TRANSDUCER OR SCANHEAD

K840408 is an FDA 510(k) clearance for LINEAR ARRAY TRANSDUCER OR SCANHEAD, manufactured by Adr Ultrasound. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K840408 · Adr Ultrasound · Radiology device
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Apr 1984
Decision
85d
Days
Class 2
Risk

K840408 is an FDA 510(k) clearance for the LINEAR ARRAY TRANSDUCER OR SCANHEAD. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Adr Ultrasound (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Adr Ultrasound devices

FDA 510(k) Submission Details - K840408

510(k) Number K840408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1984
Decision Date April 25, 1984
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 706
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K840408.
CIVCO/SUPER SCAN
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SDL-30
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ULTRA IMAGER 2000
K834282 · Honeywell, Inc. · Apr 1984
LINEAR SCANNER 640
K840667 · Ge Medical Systems Information Technologies · Apr 1984
DSL-150
K840611 · Shimadzu Corp. · Apr 1984