FDA.reportPublic FDA data

Fibertracking

Primary DI
04056481145897
Brand
Fibertracking
Company
Brainlab SE
Model
3.0
Published
2025-06-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243633000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243633000Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)Brainlab AG2025-06-13QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481145897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481145897040564811458974056481145897

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic system application softwareAn application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481145804Brainlab Origin OR1.02026-08-21
04056481006525Em Disposable Stylet18097180972018-02-08
04056481141141Disposable Pre-calibrated Suction Charr. 1252185-012021-03-08
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146429Automatic Regsitration2.72026-02-20
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145613Vascular Navigation PAD2.02025-09-11
04056481146672Mixed Reality Spine Navigation1.12025-07-31
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481146320Alignment Software Spine2.12025-06-16
04056481145828Microscope Navigation1.72025-06-11
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm564162025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mm564172025-02-24
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm564182025-02-24
04056481146047Cirq Robotic Tracking Array 10.056302A2025-02-24
04056481146337Alignment Software Cranial with LITT2.12025-02-24
04056481145514Z-touch Laser Registration Pointer18370-10A2025-02-13

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Primary DI, Brand, Company table
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00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00754016387111ANDIImeka Solutions IncQIH2023-09-01
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
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00817886020356JointsMEDSTRAT, INC.LLZ2021-06-01
00817886020349JointsMEDSTRAT, INC.LLZ2021-04-05
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00817886020325JointsMEDSTRAT, INC.LLZ2021-01-29