Cleared Traditional

K212420 - Brainlab Elements

K212420 is the FDA 510(k) clearance for Brainlab Elements by Brainlab AG. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K212420 · Brainlab AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
134d
Days
Class 2
Risk

K212420 is an FDA 510(k) clearance for the Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertrack.... Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on December 16, 2021 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Brainlab AG devices

Submission Details

510(k) Number K212420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2021
Decision Date December 16, 2021
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1091
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K212420.
CONVIVO In Vivo Pathology Suite
K211156 · Carl Zeiss Meditec, AG · Dec 2021
Claritas iPET
K213140 · Claritas Healthtech Pte, Ltd. · Dec 2021
Libby IAAA v1.0
K210931 · Dyad Medical, Inc. · Dec 2021
BIT-Motion
K211039 · Dde Mri Solutions, Ltd. · Dec 2021
Will3D
K211114 · Hdx Will Corp. · Dec 2021
EXA
K203743 · Konica Minolta Healthcare Americas, Inc. · Dec 2021