Cleared Traditional

K892860 - SATURNE 41

K892860 is the FDA 510(k) clearance for SATURNE 41 by General Electric Co.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K892860 · General Electric Co. · Radiology device
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Jun 1989
Decision
66d
Days
Class 2
Risk

K892860 is an FDA 510(k) clearance for the SATURNE 41. 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 June 23, 1989 after a review of 66 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K892860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date June 23, 1989
Days to Decision 66 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
41d faster than avg
Panel avg: 107d · This submission: 66d
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 K892860.
SRS-200 RADIOSURGERY SYSTEM
K891292 · Philips Medical Systems North America, Inc. · Sep 1989
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 42 AND 43
K883019 · General Electric Co. · Nov 1988
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