Cleared Traditional

K896353 - GE TARGET SERIES 2

K896353 is an FDA 510(k) clearance for GE TARGET SERIES 2, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K896353 · GE Medical Systems · Radiology device
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Dec 1989
Decision
46d
Days
Class 2
Risk

K896353 is an FDA 510(k) clearance for the GE TARGET SERIES 2. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5840 - 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 GE Medical Systems devices

FDA 510(k) Submission Details - K896353

510(k) Number K896353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date December 22, 1989
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPQ Device Classification - Class 2, Special Controls

Product Code KPQ System, Simulation, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5840
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 - KPQ System, Simulation, Radiation Therapy

All 31
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K896353.
MODULEX RTP SYSTEM
K913017 · Computerized Medical Systems, Inc. · Oct 1991
XIMATRON/CT OPTION
K910647 · Fischer Imaging Corp. · Sep 1991
AUTOCOMP
K911340 · Victoreen, Inc. · Aug 1991
SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
K891293 · Philips Medical Systems North America, Inc. · Apr 1989
XIMAVIEW(TM)
K884323 · Varian Assoc., Inc. · Apr 1989
BEAMSCAN
K853671 · Victoreen, Inc. · Jan 1986