Cleared Traditional

K862844 - 7.5 MHZ LINEAR PROBE, CAT. NO. H4221H

K862844 is an FDA 510(k) clearance for 7.5 MHZ LINEAR PROBE, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K862844 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
119d
Days
Class 2
Risk

K862844 is an FDA 510(k) clearance for the 7.5 MHZ LINEAR PROBE, CAT. NO. H4221H. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on November 25, 1986 after a review of 119 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

FDA 510(k) Submission Details - K862844

510(k) Number K862844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date November 25, 1986
Days to Decision 119 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
12d slower than avg
Panel avg: 107d · This submission: 119d
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 329
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K862844.
280SL IMAGING SYSTEM SMALL PARTS PROBES
K864135 · Ge Medical Systems Information Technologies · Jan 1987
260SL IMAGING SYSTEM SMALL PARTS PROBES
K864136 · Ge Medical Systems Information Technologies · Jan 1987
ULTRASOUND TRANSDUCER ASSEMBLY
K862211 · Johnson & Johnson Professionals, Inc. · Jan 1987
BI-PLANE TRANSRECTAL PROBE NUMBER H4221T
K862911 · General Electric Co. · Oct 1986
5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM
K860009 · Johnson & Johnson Professionals, Inc. · Aug 1986
ULTRASONIC IMAGING SYSTEM (MODIFIED)
K860568 · Interspec, Inc. · Aug 1986