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Octavius I, Octavius II, Octavius III, Octavius 4D

by Ptw-Freiburg Physikalisch-Technische-Werkstaetten

510(k) K160405

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160405 Date20 Oct 2017ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2577-2023 FDA Class II initiated 7 Jun 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. Therefore, the measurement result will be incorrect by using such a calibration file.

    • Terminated Z-0479-2022 FDA Class II initiated 27 Aug 2021

    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 affects patient plan verification results

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Ptw-Freiburg Physikalisch-Technische-Werkstaetten

  • Beamscan MR

    Class II

  • Veriqa Open recall

    Class II