OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D— 510(k) K160405
Substantially EquivalentPtw-Freiburg Physikalisch-Technische-Werkstaetten
FDA 510(k) clearance K160405 for OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D, Substantially Equivalent on 2017-10-20. Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten. Device class: 2.
Clearance details
- Applicant
- Ptw-Freiburg Physikalisch-Technische-Werkstaetten
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, DE
Recent devices under product code IYE
view allMore clearances from Ptw-Freiburg Physikalisch-Technische-Werkstaetten
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K160405
K-number listed on FDA's recall record- Z-2577-2023 — BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)
- Z-0479-2022 — Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160405.
Data sourced from openFDA. This site is unofficial and independent of the FDA.