Cleared Traditional

K801454 - DATASON RTL

K801454 is an FDA 510(k) clearance for DATASON RTL, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K801454 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
84d
Days
Class 2
Risk

K801454 is an FDA 510(k) clearance for the DATASON RTL. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Co. devices

FDA 510(k) Submission Details - K801454

510(k) Number K801454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date September 16, 1980
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 651
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K801454.
MINIVISOR TERMINAL
K802263 · Organon Teknika Corp. · Oct 1980
AQUASONIC 100 ULTRASOUND TRANS. GEL,
K802146 · Parker Laboratories, Inc. · Oct 1980
SONIA-SO NOGRAPH-NUMERICAL ANALYSIS
K801844 · Cgr Medical Corp. · Oct 1980
MARK V DUPLEX ULTRASONIC SCANNING SYSTEM
K801598 · Advanced Technology Laboratories, Inc. · Aug 1980
MARK III ULTRASONIC SCANNING SYSTEM
K801406 · Advanced Technology Laboratories, Inc. · Jul 1980
EDP 1200 ULTRASONIC B-SCANNER
K801056 · Technicare Corp. · Jun 1980