LEKSELL GAMMA KNIFE PERFEXION— 510(k) K120811

Clearance details

Applicant

Elekta Instrument AB

Product code

Code IWB

Device class

Class 2

Regulation

21 CFR 892.5750

Advisory panel

Radiology

Date received

2012-03-16

Decision date

2012-05-24

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 K120811.