Brainscan Radiosurgery Module

FDA 510(k) K920879 · Brainlab

Substantially Equivalent

510(k) numberK920879

Submission

Device name
Brainscan Radiosurgery Module
Applicant
Brainlab
West Germany, DE
Received
February 26, 1992
Decision date
December 29, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Brainscan Radiosurgery Module cleared by the FDA?

Brainscan Radiosurgery Module (K920879) received a 510(k) decision of Substantially Equivalent on December 29, 1992, 307 days after the submission was received.

What is the product code of K920879?

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