Cleared Traditional

K883019 - SATURNE 42 AND 43

K883019 is the FDA 510(k) clearance for SATURNE 42 AND 43 by General Electric Co.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K883019 · General Electric Co. · Radiology device
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Nov 1988
Decision
114d
Days
Class 2
Risk

K883019 is an FDA 510(k) clearance for the SATURNE 42 AND 43. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on November 10, 1988 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 K883019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1988
Decision Date November 10, 1988
Days to Decision 114 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
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 316
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K883019.
VERICORD S3
K894123 · Philips Medical Systems, Inc. · Aug 1989
SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE
K892845 · Philips Medical Systems, Inc. · Jul 1989
SATURNE 41
K892860 · General Electric Co. · Jun 1989
SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25
K883264 · Philips Medical Systems, Inc. · Oct 1988
MODIFIED SL-SERIES LINEAR ACCELERATORS
K883067 · Philips Medical Systems, Inc. · Sep 1988
SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
K882231 · Philips Medical Systems, Inc. · Sep 1988