510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920879Substantially Equivalent

Brainscan Radiosurgery Module

Brainlab, Inc., West Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920879 is the FDA 510(k) clearance record for BRAINSCAN RADIOSURGERY MODULE, a class II device, cleared for Brainlab on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 146 510(k) clearances for Brainlab, from to . As of , FDA records show one recall naming K920879.

Clearance record

Decision date
Received
(307 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Brainlab Wittelsbacherstr. 8, West Germany, DE
510(k) summary
Statement
Third party review
No

Clearances, product code IYE

Trailing 12 months
16 clearances under product code IYE in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260