510(k) · Cleared
Recalled · 2011Portalvision Advanced Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Jun 23, 2009 as substantially equivalent to K003636 (Varian Medical Systems, Inc., 2001) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2009
- Review
- 60 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901932 (1991). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK901932 Varian Electronic Portal Imaging SystemVarian Assoc., Inc. · 1991
- 1 generation backK971839 Varian Radiation Therapy Imaging SystemVarian Medical Systems, Inc. · 1997
- This deviceK091209 Portalvision Advanced ImagingVarian Medical Systems, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK200940 BeamSiteDoseoptics, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK212606 BeamSiteDoseoptics, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901932 | Varian Electronic Portal Imaging System | Varian Assoc., Inc. | 1991 | — |
| −1 | K971839 | Varian Radiation Therapy Imaging System | Varian Medical Systems, Inc. | 1997 | — |
| 0 (this device) | K091209 | Portalvision Advanced Imaging | Varian Medical Systems, Inc. | 2009 | — |
| +1 | K200940 | BeamSite | Doseoptics, LLC | 2020 | — |
| +2 | K212606 | BeamSite | Doseoptics, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003636 | PortalvisionSummary page 1…CER-§892:5050,~. Product Code: 90IYE ' 3. Predicate Device to claim substantial equivalence: Varian PortalVision -K003636 and Varian Radiotherapy Imaging System (RTIS) - K971839 4. Description of the Device: The PortalVision Advan… | 2001 |
| * | K971839 | Varian Radiation Therapy Imaging SystemSummary page 1…90IYE ' 3. Predicate Device to claim substantial equivalence: Varian PortalVision -K003636 and Varian Radiotherapy Imaging System (RTIS) - K971839 4. Description of the Device: The PortalVision Advanced Imaging (PVAI) device combines two previously cleare… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200940 | BeamSite | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2011 | Not classified | Z-0516-2012 | Software design | An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200940 (Doseoptics, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K003636.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The PortalVision Advanced Imaging device is used to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091209: Portalvision Advanced Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091209
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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