510(k) · Cleared
ClearedRadiocameras System Head/Neck Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Navigation Technologies, Inc. · IYE Accelerator, Linear, Medical
Cleared on Mar 22, 2000 after a 90-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Mar 22, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK994355 Radiocameras System Head/Neck ApplicationSurgical Navigation Technologies, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK071360 Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK142560 Varian Head FrameVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK180586 Varian Head FrameVarian Medical Systems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK042875 NavigatorNomos Corp. · 2005
Most influential descendants
Showing 4 of 4 · See all- K071360Optical Guidance PlatformVarian Medical Systems, Inc. · 2007 · cites it directly2descendants
- K142560Varian Head FrameVarian Medical Systems, Inc. · 2014 · 2 generations on1descendant
- K180586Varian Head FrameVarian Medical Systems, Inc. · 2018 · 3 generations on0descendants
- K042875NavigatorNomos Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994355 | Radiocameras System Head/Neck Application | Surgical Navigation Technologies, Inc. | 2000 | — |
| +1 | K071360 | Optical Guidance Platform | Varian Medical Systems, Inc. | 2007 | 5 |
| +2 | K142560 | Varian Head Frame | Varian Medical Systems, Inc. | 2014 | 1 |
| +3 | K180586 | Varian Head Frame | Varian Medical Systems, Inc. | 2018 | — |
| +1 | K042875 | Navigator | Nomos Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K071360 (Varian Medical Systems, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a photon linear accelerator to perform Stereotactic Radiosurgery or Radiotherapy on head and neck theraputic targets that lie outside the cranium. It provides precise positioning of the treatment target at the Linear Accelerator's isocenter.
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/K994355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994355: Radiocameras System Head/Neck Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994355
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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