Frameless Radiosurgery Components

FDA 510(k) K053500 · Brainlab AG

Substantially Equivalent

510(k) numberK053500

Submission

Device name
Frameless Radiosurgery Components
Applicant
Brainlab AG
Heimstetten, DE
Received
December 16, 2005
Decision date
February 3, 2006
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 Frameless Radiosurgery Components cleared by the FDA?

Frameless Radiosurgery Components (K053500) received a 510(k) decision of Substantially Equivalent on February 3, 2006, 49 days after the submission was received.

What is the product code of K053500?

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