510(k) · Cleared
Recalled · Class II · 2023Octavius I, Octavius II, Octavius Iii, Octavius 4D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ptw-Freiburg Physikalisch-Technische-Werkstaetten · IYE Accelerator, Linear, Medical
Cleared on Oct 20, 2017 as substantially equivalent to K131466 (Sun Nuclear Corporation, 2013) after a 612-day review. Its family tree reaches back 2 generations to 1994. It has been recalled 2 times.
- Decided
- Oct 20, 2017
- Review
- 612 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935928 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK935928 Rit 113 Film Analysis SystemRadiological Imaging Technology, Inc. · 1994
- 1 generation backK131466 MAPCHECK2, ArccheckSun Nuclear Corporation · 2013
- This deviceK160405 Octavius I, Octavius II, Octavius Iii, Octavius 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935928 | Rit 113 Film Analysis System | Radiological Imaging Technology, Inc. | 1994 | — |
| −1 | K131466 | MAPCHECK2, Arccheck | Sun Nuclear Corporation | 2013 | — |
| 0 (this device) | K160405 | Octavius I, Octavius II, Octavius Iii, Octavius 4D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2017 | — |
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 |
|---|---|---|---|
| * | K131466 | MAPCHECK2, ArccheckSummary page 4…harged-particle radiation therapy system, Product Code: IYE 9. Predicate Device: Sun Nuclear’s “MapCHECK2” and “ArcCHECK” (K131466) 10. Device Description: The OCTAVIUS System is comprised of a two-dimensional ion c… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2023 | Class II | Z-2577-2023 | Under Investigation by firm | Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result… |
| Aug 27, 2021 | Class II | Z-0479-2022 | Software design | When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 19.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K131466.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 OCTAVIUS System is intended to collect beam data for patient plan verification of a treatment planning system (TPS) and under the aspect of machine QA for the following purposes:
- IMRT patient plan verification
- periodic QA procedures, e.g. constancy checks
- beam data analysis according to international therapy dosimetry protocols
- measurements after repair or replacement of major treatment unit components
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160405: Octavius I, Octavius II, Octavius Iii, Octavius 4D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160405
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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