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

FDA 510(k) K160405 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten

Substantially Equivalent

510(k) numberK160405

Submission

Device name
Octavius I, Octavius II, Octavius III, Octavius 4D
Applicant
Ptw-Freiburg Physikalisch-Technische-Werkstaetten
Freiburg, DE
Received
February 16, 2016
Decision date
October 20, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Octavius I, Octavius II, Octavius III, Octavius 4D cleared by the FDA?

Octavius I, Octavius II, Octavius III, Octavius 4D (K160405) received a 510(k) decision of Substantially Equivalent on October 20, 2017, 612 days after the submission was received.

What is the product code of K160405?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.