FDA.reportPublic FDA data

Leksell Stereotactic System

Primary DI
07340201502556
Brand
Leksell Stereotactic System
Company
Elekta Solutions AB
Model
1040329
Catalog number
1040329
Device description
MR-Adapter Siemens TxRx CP HC
Published
2025-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152558000Leksell Stereotactic System, Injection/ Aspiration Needle KitElekta Instrument AB2016-03-02HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340201502556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340201502556073402015025567340201502556

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353272181
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340201502976Leksell Vantage Stereotactic System11191152026-06-10
07340201501887Leksell Vantage Stereotactic System10400642025-03-31
07340201503737VISUAL GUIDANCE157397215739722026-04-28
07340201500118MonacoMonaco 6.32026-03-20
07340201503461EMLA (Elekta EVO)15716442026-02-16
07340201503898Leksell GammaPlan15777562026-02-04
07340201502136Leksell GammaPlan15677142024-02-14
07340201503782AQUAAQUA 3.32025-12-10
07340201501368Leksell Vantage Stereotactic System104002610400272024-06-18
07340201501795Leksell Vantage Stereotactic System104011010401102024-06-17
07340201501535Leksell Vantage Stereotactic System104004510400452024-06-17
07340201502433Leksell Stereotactic System10403222025-10-17
07340201502266Leksell Stereotactic System104036010403152025-09-17
07340201502426Leksell Stereotactic System104049010403232025-09-17
07340201502457Leksell Stereotactic System10404991040319 2025-09-17
07340201502471Leksell Stereotactic System104035610403132025-09-17
07340201502495Leksell Stereotactic System104036410403172025-09-17
07340201502587Leksell Stereotactic System104035810403142025-09-17
07340201502273Leksell Stereotactic System104036010403152025-09-17
07340201503317Leksell Stereotactic System104049010403232025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695107Instrument Adaptor (8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695121SEEG AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695145Catheter AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695169Thumb Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695183Set Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695206Pin Screw of Instrument AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695220Catheter Adaptor_3.5mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695244Instrument Adaptor (1.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695268Instrument Adaptor (2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695282Instrument Adaptor (2.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695305Instrument Adaptor (2.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695329Instrument Adaptor (2.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695343Instrument Adator (3.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695367Instrument Adaptor (3.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695381Instrument Adaptor (4.6 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25