Cleared Traditional

K810749 - 5 MHZ TRANSDUCER

K810749 is the FDA 510(k) clearance for 5 MHZ TRANSDUCER by General Electric Co.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K810749 · General Electric Co. · Radiology device
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Apr 1981
Decision
28d
Days
Class 2
Risk

K810749 is an FDA 510(k) clearance for the 5 MHZ TRANSDUCER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 28 days - a notably fast clearance cycle.

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: 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 General Electric Co. devices

Submission Details

510(k) Number K810749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1981
Decision Date April 17, 1981
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 188
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K810749.
3.5 MHZ BIOPSY TRANSDUCER
K812929 · General Electric Co. · Nov 1981
BIOPSY TRANSDUCER
K811843 · Siemens Gammasonics, Inc. · Aug 1981
7.5 MHZ WP TRANSDUCER
K810748 · General Electric Co. · Jun 1981
MARK V DUPLEX ULTRASONIC SCAN SYS.
K802438 · Advanced Technology Laboratories, Inc. · Jan 1981
IN-LINE SCAN HEAD MODIFICATION MARK III
K801971 · Advanced Technology Laboratories, Inc. · Oct 1980
IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA
K801973 · Advanced Technology Laboratories, Inc. · Oct 1980