Cleared Traditional

K864222 - SERIES 620 RECTAL PROBE COVER

K864222 is an FDA 510(k) clearance for SERIES 620 RECTAL PROBE COVER, 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 127-day FDA review.

K864222 · General Electric Co. · Radiology device
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Mar 1987
Decision
127d
Days
Class 2
Risk

K864222 is an FDA 510(k) clearance for the SERIES 620 RECTAL PROBE COVER. 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 March 4, 1987 after a review of 127 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 - K864222

510(k) Number K864222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 04, 1987
Days to Decision 127 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
20d slower than avg
Panel avg: 107d · This submission: 127d
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
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