510(k) · Cleared
ClearedVarian Ximatron Scan Vision CT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · KPR System, X-Ray, Stationary
Cleared on Jun 12, 1998 as substantially equivalent to K910647 (Fischer Imaging Corp., 1991) after an 81-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Jun 12, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910647 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK910647 Ximatron/CT OptionFischer Imaging Corp. · 1991
- This deviceK981056 Varian Ximatron Scan Vision CTVarian Medical Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK033339 Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K033339Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910647 | Ximatron/CT Option | Fischer Imaging Corp. | 1991 | — |
| 0 (this device) | K981056 | Varian Ximatron Scan Vision CT | Varian Medical Systems, Inc. | 1998 | — |
| +1 | K033339 | Acuity with Conebeam Computed Tomography | Varian Medical Systems, Inc. | 2003 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 KPR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K910647 | Ximatron/CT OptionSummary page 1….com Varian Ximatron ScanVision with Version 5.0 Software iflcation N : Radiation Therapy Simulation System Varian Ximatron CT Option cleared to market per 510(k) No. K910647 Prodyct Description: The Varian Ximatron ScanVision is an attachment to the Varian Radiation therapy simulator Ximatron, 8canV… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033339 | Acuity with Conebeam Computed Tomography | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K033339 (Varian Medical Systems, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The Varian Ximatron ScanVision CT device is an attachment to the Varian Radiation therapy simulator Ximatron. It is to be used to obtain CT images of the patient in the intended treatment position, for the purposes of radiation therapy treatment planning.
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/K981056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981056: Varian Ximatron Scan Vision CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981056
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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