510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K915819Substantially Equivalent

Brainscan Workstation

Brainlab Medizinische Computersysteme GmbH, West Germany, GR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915819 is the FDA 510(k) clearance record for BRAINSCAN WORKSTATION, a class II device, cleared for Brainlab Medizinische Computersysteme GmbH on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list one 510(k) clearance for Brainlab Medizinische Computersysteme GmbH. As of , FDA records show no recalls naming K915819.

Clearance record

Decision date
Received
(133 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Brainlab Medizinische Computersysteme GmbH Wittelsbacherstr 8, West Germany, GR
510(k) summary
Statement
Third party review
No

Clearances, product code HAW

Trailing 12 months
4 clearances under product code HAW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HAW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20261
October 20260