Cleared Traditional

BI-PLANE TRANSRECTAL PROBE NUMBER H4221T (K862911) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862911 · General Electric Co. · Radiology device
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Oct 1986
Decision
91d
Days
Class 2
Risk

K862911 is an FDA 510(k) clearance for the BI-PLANE TRANSRECTAL PROBE NUMBER H4221T. 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 October 31, 1986 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 K862911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1986
Decision Date October 31, 1986
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 63
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K862911.
RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE
K863700 · General Electric Co. · Feb 1987
ULTRASOUND TRANSDUCER ASSEMBLY
K862211 · Johnson & Johnson Professionals, Inc. · Jan 1987
7.5 MHZ LINEAR PROBE, CAT. NO. H4221H
K862844 · General Electric Co. · Nov 1986
5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM
K860009 · Johnson & Johnson Professionals, Inc. · Aug 1986
PS SYSTEM WITH SD-200 DOPPLER
K861358 · Johnson & Johnson Professionals, Inc. · Jul 1986
7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER)
K861228 · General Electric Co. · Jul 1986