510(k) · Cleared
Recalled · Class II · 2014Simview 3000 CT Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · KPQ System, Simulation, Radiation Therapy
Cleared on Nov 29, 1996 as substantially equivalent to K912466 (Oldelft Corp. of America, 1991) and 1 other predicate after a 508-day review. Its family tree reaches back 1 generation to 1985. It has been recalled 4 times.
- Decided
- Nov 29, 1996
- Review
- 508 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K853349 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK853349 Varian Ximatron C-Series Radiotherapy Treatment STVarian Assoc., Inc. · 1985 · Recalled
- This deviceK953233 Simview 3000 CT OptionSiemens Medical Solutions USA, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853349 | Varian Ximatron C-Series Radiotherapy Treatment ST | Varian Assoc., Inc. | 1985 | 1 |
| 0 (this device) | K953233 | Simview 3000 CT Option | Siemens Medical Solutions USA, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K912466 | Oldelft Simulix-MCSummary page 2…n System - 21 CFR § 892.5840 Class II, Product Code: RA 90 KPQ Predicate Devices: « SIMULIX-MC-CT-EXTENSION Oldelft Corporation of America Treatment Planning Simulator, K912466 * XIMATRON /CT, Varian Associates Treatment Planning Simulator, K 853349, 82K0274 Description of Device: The SIMPLI C.T. Option… | 1991 |
| * | K853349 | Varian Ximatron C-Series Radiotherapy Treatment STSummary page 2…Devices: « SIMULIX-MC-CT-EXTENSION Oldelft Corporation of America Treatment Planning Simulator, K912466 * XIMATRON /CT, Varian Associates Treatment Planning Simulator, K 853349, 82K0274 Description of Device: The SIMPLI C.T. Option for the SIMVIEW™ 3800 provides therapeutic quality CT images at simulati… | 1985 |
| Kept off the family tree | K820274 | FDA’s K820274 is Digoxin Radioimmunoassay 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. | 1982 |
| * | — | SIMULIX-MC-CT-EXTENSION, Oldelft Corporation of America Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2014 | Class II | Z-0235-2015 | Device Design | 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 collision detection functionality. It is… |
| Dec 11, 2013 | Class II | Z-0786-2014 | Device Design | 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 | Device Design | 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 | Software design | 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 inadvertent motion and serious injury… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All KPQ devicesKPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KPQ
Too few KPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPQ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPQ
1in 2020
MAUDE reports naming product code KPQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 6 | 17 |
| 2008 | 1 | — | 3 | 12 |
| 2009 | 1 | — | 1 | 7 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 1 | 11 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953233 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953233: Simview 3000 CT Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953233
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026