510(k) · Cleared
Recalled · 2011Barcode Conical Collimator Verification (BCCV)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Oncology Systems · IYE Accelerator, Linear, Medical
Cleared on Jan 12, 2011 as substantially equivalent to K081036 (Varian Medical Systems, Inc., 2008) after a 54-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 12, 2011
- Review
- 54 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001643 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005 · Recalled
- 1 generation backK081036 4D Integrated Treatment Console with Patient Accessory Verification…Varian Medical Systems, Inc. · 2008 · Recalled
- This deviceK103394 Barcode Conical Collimator Verification (BCCV)Varian Medical Systems, Oncology Systems · 2011
- Descendant · cites it directly · 0 of its ownK142268 Varian Verification System (VVS)Varian Medical Systems, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142268Varian Verification System (VVS)Varian Medical Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001643 | Varis 1.4G | Varian Medical Systems, Inc. | 2000 | 8 |
| −2 | K050479 | 4D Integrated Treatment Console | Varian Medical Systems | 2005 | 2 |
| −1 | K081036 | 4D Integrated Treatment Console with Patient Accessory Verification System… | Varian Medical Systems, Inc. | 2008 | 3 |
| 0 (this device) | K103394 | Barcode Conical Collimator Verification (BCCV) | Varian Medical Systems, Oncology Systems | 2011 | — |
| +1 | K142268 | Varian Verification System (VVS) | Varian Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K081036 | 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs)Summary page 1…: lYE Common/Usual Name: Barcode Conical Collimator Verification (BCCV) Predicate Devices: 4D Integrated Treatment Console with PAyS, K081036 Device Description: The Barcode Conical Collimator Verification (BCCV) device provides… | 2008 |
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 |
|---|---|---|---|
| K142268 | Varian Verification System (VVS) | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2011 | Not classified | Z-0716-2012 | Device Design | When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K142268 (Varian Medical Systems, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K081036.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Barcode Conical Collimator Verification device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103394: Barcode Conical Collimator Verification (BCCV).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103394
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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