Cleared Traditional

K810748 - 7.5 MHZ WP TRANSDUCER

K810748 is the FDA 510(k) clearance for 7.5 MHZ WP TRANSDUCER by General Electric Co.. It is a Class 2 Radiology device (product code ITX) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K810748 · General Electric Co. · Radiology device
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Jun 1981
Decision
91d
Days
Class 2
Risk

K810748 is an FDA 510(k) clearance for the 7.5 MHZ WP 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 June 19, 1981 after a review of 91 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 General Electric Co. devices

Submission Details

510(k) Number K810748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1981
Decision Date June 19, 1981
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
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 K810748.
MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
K852132 · Hewlett-Packard Co. · Aug 1985
3.5 MHZ BIOPSY TRANSDUCER
K812929 · General Electric Co. · Nov 1981
BIOPSY TRANSDUCER
K811843 · Siemens Gammasonics, Inc. · Aug 1981
5 MHZ TRANSDUCER
K810749 · General Electric Co. · Apr 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