Leksell Gamma Knife Perfexion— 510(k) K151159

Clearance details

Applicant

Elekta Instrument AB

Product code

Code IWB

Device class

Class 2

Regulation

21 CFR 892.5750

Advisory panel

Radiology

Date received

2015-05-01

Decision date

2015-10-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stockholm, SE

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151159.