Cleared Traditional

K945838 - CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY

K945838 is an FDA 510(k) clearance for CTPORT CT SIMULATION SYSTEM FOR RADIOTH..., manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code KPQ cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K945838 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
330d
Days
Class 2
Risk

K945838 is an FDA 510(k) clearance for the CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY. Classified as System, Simulation, Radiation Therapy (product code KPQ), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on October 25, 1995 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Toshiba America Medical Systems, In.C devices

FDA 510(k) Submission Details - K945838

510(k) Number K945838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1994
Decision Date October 25, 1995
Days to Decision 330 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 107d · This submission: 330d
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 40
Devices cleared under the same product code (KPQ) and FDA review panel - the closest regulatory comparables to K945838.
SIMVIEW 3000 CT OPTION
K953233 · Siemens Medical Solutions USA, Inc. · Nov 1996
MODEL 555 010 XY CONVERSION(55010)
K960737 · Systems Supply Services, Inc. · May 1996
ADVANTAGE SIM
K951830 · General Electric Co. · Nov 1995
SIMVIEW(TM) 3000
K946053 · Siemens Medical Solutions USA, Inc. · Mar 1995
CMS RECORD AND VERIFY
K921108 · Computerized Medical Systems, Inc. · Nov 1992
ACQSIM SIMULATOR/LOCALIZER
K923851 · Philips Medical Systems (Cleveland), Inc. · Oct 1992