510(k) · Cleared
ClearedVarian Radiation Therapy Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · KPQ System, Simulation, Radiation Therapy
Cleared on Aug 15, 1997 as substantially equivalent to K901932 (Varian Assoc., Inc., 1991) after an 88-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.
- Decided
- Aug 15, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901932 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK901932 Varian Electronic Portal Imaging SystemVarian Assoc., Inc. · 1991
- This deviceK971839 Varian Radiation Therapy Imaging SystemVarian Medical Systems, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK091209 Portalvision Advanced ImagingVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK200940 BeamSiteDoseoptics, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK212606 BeamSiteDoseoptics, LLC · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901932 | Varian Electronic Portal Imaging System | Varian Assoc., Inc. | 1991 | — |
| 0 (this device) | K971839 | Varian Radiation Therapy Imaging System | Varian Medical Systems, Inc. | 1997 | — |
| +1 | K091209 | Portalvision Advanced Imaging | Varian Medical Systems, Inc. | 2009 | 1 |
| +2 | K200940 | BeamSite | Doseoptics, LLC | 2020 | — |
| +3 | K212606 | BeamSite | Doseoptics, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K901932 | Varian Electronic Portal Imaging SystemSummary page 1…4-5036 FAX: (415) 424-4830 Prepared: May 15, 1997 2. Device Name: Radiation Therapy Imaging System (RTIS) 3. Predicate Device: Electronic Portal Imaging System 510(k) 901932B Cleared on May 3, 1991 4. Description: RTIS is a component of imaging systems for use with radiotherapy devices such as’linear… | 1991 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091209 | Portalvision Advanced Imaging | 2009 | 2 |
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?
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?
RTIS is an imaging accessory indicated for use with radiotherapy devices such as linear accelerators and simulators. It provides rediographic/fluoroscopic images for simulations, and portal images for high energy treatment machines.
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/K971839 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971839: Varian Radiation Therapy Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971839
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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