Cranial 4Pi Immobilization
K-Number: K243142 · 2025-06-23
ApplicantBrainlab AG
Decision Date2025-06-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Cranial 4Pi Immobilization is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2025-06-23 under approval number K243142. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cranial 4Pi Immobilization?
Cranial 4Pi Immobilization is a medical device that received FDA 510(k) clearance on 2025-06-23. It is manufactured by Brainlab AG. The 510(k) number is K243142.
When was Cranial 4Pi Immobilization approved by the FDA?
Cranial 4Pi Immobilization received FDA 510(k) clearance on 2025-06-23, under approval number K243142.
What company makes Cranial 4Pi Immobilization?
Cranial 4Pi Immobilization is manufactured by Brainlab AG.
What is the FDA product code for Cranial 4Pi Immobilization?
The FDA product code for Cranial 4Pi Immobilization is IYE.
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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.