Cleared Traditional

K863700 - RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE

K863700 is an FDA 510(k) clearance for RT2800(115V)/H4008C AND RT2800(220/240V..., 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 140-day FDA review.

K863700 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
140d
Days
Class 2
Risk

K863700 is an FDA 510(k) clearance for the RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE. 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 February 10, 1987 after a review of 140 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 - K863700

510(k) Number K863700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date February 10, 1987
Days to Decision 140 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
33d slower than avg
Panel avg: 107d · This submission: 140d
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 K863700.
KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM
K862686 · Kontron Instruments, Inc. · Feb 1987
DIAGNOSTIC ULTRASONIC TRANSDUCER
K863364 · Toshiba Medical Systems · Feb 1987
INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER
K855247 · Codman & Shurtleff, Inc. · Feb 1987
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