# K160405: Octavius I, Octavius II, Octavius Iii, Octavius 4D

- Pathway: 510(k) (Traditional)
- Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten
- Decided: Oct 20, 2017 after 612 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935928 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131466: MAPCHECK2, Arccheck, Sun Nuclear Corporation (2013) Summary page 4.

## Recalls of this device
- Jun 7, 2023 · Class II · Z-2577-2023: 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.
- Aug 27, 2021 · Class II · Z-0479-2022: 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

## Indications for use
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

Source page: https://510kreport.com/device/K160405
Methodology: https://510kreport.com/methodology