Cleared Traditional

Cranial 4Pi Immobilization

K243142 · Brainlab AG · Radiology
Jun 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K243142 is an FDA 510(k) clearance for the Cranial 4Pi Immobilization, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on June 23, 2025, 266 days after receiving the submission on September 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K243142 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date June 23, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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