Cleared Traditional

K243698 - Alignment System Cranial

Also marketed or referenced as:
Cirq Alignment Software Cranial Biopsy Cirq Alignment Software Cranial sEEG VarioGuide Alignment Software Cranial Cirq Alignment Software Cranial LITT

K243698 is the FDA 510(k) clearance for Alignment System Cranial by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K243698 · Brainlab AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
60d
Days
Class 2
Risk

K243698 is an FDA 510(k) clearance for the Alignment System Cranial, with Alignment Software Cranial with LITT. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on January 28, 2025 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brainlab AG devices

Submission Details

510(k) Number K243698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2024
Decision Date January 28, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K243698.
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025
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K242575 · Brain Navi Biotechnology Co., Ltd. · May 2025
Navient Image Guide Navigation System (955-NC-NC), Cranial
K241327 · Claronav · Feb 2025
ClearPoint System (Software Version 3.0)
K243657 · ClearPoint Neuro, Inc. · Jan 2025
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K241333 · KOH YOUNG TECHNOLOGY, Inc. · Jan 2025
FLASH EVD System (10-0002)
K242480 · 7D Surgical ULC · Dec 2024