OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
K-Number: K160405 · 2017-10-20
Decision Date2017-10-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D is a medical device manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten. It received FDA 510(k) clearance on 2017-10-20 under approval number K160405. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D?
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D is a medical device that received FDA 510(k) clearance on 2017-10-20. It is manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten. The 510(k) number is K160405.
When was OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D approved by the FDA?
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D received FDA 510(k) clearance on 2017-10-20, under approval number K160405.
What company makes OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D?
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D is manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten.
What is the FDA product code for OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D?
The FDA product code for OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D is IYE.
Other Devices by Ptw-Freiburg Physikalisch-Technische-Werkstaetten
Related Devices (Code: IYE)
K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc.
K161400ImagingRing SystemMedphoton GmbH
K162468ClearCheckRadformation
K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV
K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC
K162265CushionCast Moldable CushionsIzi Medical Products, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.