Cleared Traditional

K862911 - BI-PLANE TRANSRECTAL PROBE NUMBER H4221T

K862911 is an FDA 510(k) clearance for BI-PLANE TRANSRECTAL PROBE NUMBER H4221T, 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 91-day FDA review.

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

FDA 510(k) Submission Details - K862911

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.

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 K862911.
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