Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
K-Number: K173789 · 2018-03-30
ApplicantElekta Instrument AB
Decision Date2018-03-30
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon is a medical device manufactured by Elekta Instrument AB. It received FDA 510(k) clearance on 2018-03-30 under approval number K173789. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon?
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Elekta Instrument AB. The 510(k) number is K173789.
When was Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon approved by the FDA?
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon received FDA 510(k) clearance on 2018-03-30, under approval number K173789.
What company makes Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon?
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon is manufactured by Elekta Instrument AB.
What is the FDA product code for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon?
The FDA product code for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon is IWB.
Other Devices by Elekta Instrument AB
Related Devices (Code: IWB)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.