Cleared Traditional

K910647 - XIMATRON/CT OPTION

K910647 is an FDA 510(k) clearance for XIMATRON/CT OPTION, manufactured by Fischer Imaging Corp.. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K910647 · Fischer Imaging Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
218d
Days
Class 2
Risk

K910647 is an FDA 510(k) clearance for the XIMATRON/CT OPTION. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Fischer Imaging Corp. (Denver, US). The FDA issued a Cleared decision on September 19, 1991 after a review of 218 days - an extended review 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: 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 Fischer Imaging Corp. devices

FDA 510(k) Submission Details - K910647

510(k) Number K910647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1991
Decision Date September 19, 1991
Days to Decision 218 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
111d slower than avg
Panel avg: 107d · This submission: 218d
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 41
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K910647.
CMS RECORD AND VERIFY
K921108 · Computerized Medical Systems, Inc. · Nov 1992
ACQSIM SIMULATOR/LOCALIZER
K923851 · Philips Medical Systems (Cleveland), Inc. · Oct 1992
MODULEX RTP SYSTEM
K913017 · Computerized Medical Systems, Inc. · Oct 1991
AUTOCOMP
K911340 · Victoreen, Inc. · Aug 1991
GE TARGET SERIES 2
K896353 · GE Medical Systems · Dec 1989
SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
K891293 · Philips Medical Systems North America, Inc. · Apr 1989