# K953233: Simview 3000 CT Option

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 29, 1996 after 508 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853349 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912466: Oldelft Simulix-MC, Oldelft Corp. of America (1991) Summary page 2.
- K853349: Varian Ximatron C-Series Radiotherapy Treatment ST, Varian Assoc., Inc. (1985) Summary page 2.
- (no number) SIMULIX-MC-CT-EXTENSION, Oldelft Corporation of America: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K820274: Digoxin Radioimmunoassay, American Diagnostic Corp. (1982). Our OCR of the scanned summary read K820274, FDA’s number for Digoxin Radioimmunoassay (American Diagnostic Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “XIMATRON /CT, Varian Associates; Treatment Planning Simulator”. Kept off the family tree.

## Recalls of this device
- Oct 10, 2014 · Class II · Z-0235-2015: Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collisio
- Dec 11, 2013 · Class II · Z-0786-2014: In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.
- Nov 6, 2008 · Not classified · Z-0646-2009: Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.
- Mar 10, 2008 · Not classified · Z-2196-2008: The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling in

## Indications for use
The SIMPLI C.T. Option for the SIMVIEW™ 3000 radiation therapy is used for the following: 1. To obtain CT images in the same position as the treatment. 2. To provide CT images to determine the contour of the patient. 3. To provide CT images to determine the size and location of internal structures. 4. To provide CT images to be used by the dosimetrist to determine the location of isocenter. 5. To provide tissue density information via Hounsfield numbers, which allows for more accurate calculations of the dose by accounting for variations in tissue densities. The intended use is the same as the predicate devices.

Source page: https://510kreport.com/device/K953233
Methodology: https://510kreport.com/methodology