FDA.reportPublic FDA data

Automatic Registration

Primary DI
04056481145101
Brand
Automatic Registration
Company
Brainlab SE
Model
2.6
Device description
The Automatic Registration - is a software module, that when used with a compatible computer workstation and compatible registration accessories provides a “registration” for subsequent navigation applications.
Published
2023-09-22
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
HAWNeurological Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223288000
K223864000
K234047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223288000Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIBrainlab AG2023-07-21HAW
K223864000Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AG2023-09-09HAW
K234047000Automatic RegistrationBrainlab AG2024-03-20OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481145101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481145101040564811451014056481145101

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

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
04056481147099Buzz O.R. Compute179222026-07-09
04056481122751Sterilization Tray Standards Cranial Accessories523152020-10-21
04056481122867Sterilization Tray Frameless Biopsy System523042020-10-21
04056481122874Sterilization Tray Varioguide523032020-10-21
04056481095406STERILIZATION TRAY SPINE BASIC/ANT/UNIV52306A52306A2020-04-02
04056481122812STERILIZATION TRAY HIP REPLACEMENT52309523092020-04-02
04056481122904Sterilization Tray Trauma / Knee Arthroscopy523002020-01-31
04056481122805Sterilization Tray Hip Resurfacing52310523102019-09-27
04056481004835Em Sterilization Tray Basic Instruments18099-08A18099-08A2016-09-15
04056481002718Headband Reference Star - Connector41877-1041877-102016-09-15
04056481003715Mscope Adapter Hs/Moeller Hi-R 700/100041767-8541767-852016-09-15
04056481141363CRANIAL 4PI CT TABLE OVERLAY434302022-05-31
04056481006884ELEMENTS LEAD LOCALIZATION1.026338-022016-11-18
04056481131920Registr. Matrix Imri Ge Headholder19202C19202C2016-09-17
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481144609ExacTrac Dynamic 2.02025-02-19
04056481144654Viewer 5.45.42024-11-05
04056481004101Target Positioner Leksell40700-20A40700-20A2016-09-15
04056481006525Em Disposable Stylet18097180972018-02-08
04056481138769Elements Trajectory Planning2.026250-02C2017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000914035Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914042Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914059Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914066Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914073Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000914080Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
00763000953805Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-17
18257200140367NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140374NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140381NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140398NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140404NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140411NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140428NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140435NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140442NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140459NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140466NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140473NAVIGATED INSTRUMENTS,PHOENIX SFSOrthofix US LLCOLO2026-07-17
18257200140527FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140534FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140558FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140565FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140572FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140596FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140602FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140619FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140626FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140633FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17
18257200140657FIREBIRD NXG POCT,NAVIGATED INSTRUMENTSOrthofix US LLCOLO2026-07-17