FDA.reportPublic FDA data

ExacTrac Dynamic

Primary DI
04056481144609
Brand
ExacTrac Dynamic
Company
Brainlab SE
Model
2.0
Published
2025-02-19
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
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240431000
K254010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240431000ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG2024-07-24IYE
K254010000ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE2026-01-14IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481144609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481144609040564811446094056481144609

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. 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
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
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
04056481141981HIP77.02020-06-08
04056481140809Curve 1.2 Dual Navigation Station19901B2023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.IYE2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.IYE2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.IYE2026-04-22
08720168160140DSPS-Prominent® baseplate MACROMEDICS B.V.IYE2026-04-21
08720168162557DSPS-Prominent® Cradle-IMACROMEDICS B.V.IYE2026-04-21
08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
EPTWS0700300PQASoftPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTW600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15