Beamscan

FDA 510(k) K161807 · Ptw-Freiburg Physikalisch Technische-Werksraetten

Substantially Equivalent

510(k) numberK161807

Submission

Device name
Beamscan
Applicant
Ptw-Freiburg Physikalisch Technische-Werksraetten
Freiburg, DE
Received
July 1, 2016
Decision date
May 19, 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 Beamscan cleared by the FDA?

Beamscan (K161807) received a 510(k) decision of Substantially Equivalent on May 19, 2017, 322 days after the submission was received.

What is the product code of K161807?

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