FDA.reportPublic FDA data

Leksell Stereotactic System

Primary DI
07340201503331
Brand
Leksell Stereotactic System
Company
Elekta Solutions AB
Model
1040179
Catalog number
1040179
Device description
MR Phantom
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
07340201503331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340201503331073402015033317340201503331

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
07340201500057ProKnow DS2.02024-03-21
07340201500040AATMAAATMA2022-03-09
07340201503683Leksell Vantage Stereotactic System113643111364312026-08-18
07340201503713Leksell Vantage Stereotactic System113654511365452026-08-18
07340201503720Leksell Vantage Stereotactic System113656111365612026-08-18
07340201503744Leksell Vantage Stereotactic System113651211365122026-08-18
07340201503768Leksell Vantage Stereotactic System113652811365282026-08-18
07340201503942Leksell Vantage Stereotactic System157809715780972026-08-18
07340201503959Leksell Vantage Stereotactic System157809415780942026-08-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974813832681NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832735NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832742NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832766NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832773NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832780NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832797NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832810NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832827NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832834NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832841NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00199150071968Stealth AXiS Leica KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071975Stealth AXiS Kinevo 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00199150071982Stealth AXiS Pentero 900 KitMEDTRONIC NAVIGATION, INC.HAW2026-09-25
00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
00199150054404ZEISS TIVATO 700MEDTRONIC NAVIGATION, INC.HAW2026-09-21
00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503713Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18