FDA.reportPublic FDA data

Leksell Gamma Knife Icon

Primary DI
07340048311786
Brand
Leksell Gamma Knife Icon
Company
Elekta Instrument AB
Model
1075251
Device description
LEKSELL VANTAGE ADAPTER LGK
Published
2021-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWBSystem, radiation therapy, radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWBSystem, Radiation Therapy, RadionuclideRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340048311779Direct MarkingGS10
07340048311786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340048311779073400483117797340048311779
07340048311786073400483117867340048311786

GMDN Terms#

Term, Definition table
TermDefinition
Teletherapy radionuclide system, conventionalA stationary assembly of computer-based devices designed to deliver a therapeutic radiation dose to an anatomical region from a single external radiation beam produced by a radionuclide source, typically to treat malignant tumours; it does not provide image-guided radiation therapy (IGRT) functionality during treatment delivery. A typical system is: 1) the treatment head (a shielded source vault containing a single radioactive source); 2) a rotating or fixed gantry with the treatment head; 3) a collimator mechanism attached to the gantry to align the treatment beam; 4) a moveable patient table; and 5) an operator's console with controls. It is commonly known as a cobalt therapy machine.

Contacts#

Phone, Email table
PhoneEmail
+1(855)693-5358info.america@elekta.com

Regulatory Flags#

DUNS number
507772663
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340048304474Leksell Stereotactic System9128772016-10-21
07340048304535Leksell Stereotactic System9171202016-09-24
07340048304542Leksell Stereotactic System9171192016-09-24
07340048304559Leksell Stereotactic System9171182016-09-24
07340048311175Leksell Stereotactic System153003615300362017-02-07
07340048311182Leksell Stereotactic System153003815300382017-02-07
07340048311199Leksell Stereotactic System153003915300392017-02-07
07340048311205Leksell Stereotactic System153004015300402017-02-07
07340048311212Leksell Stereotactic System153004115300412017-02-07
07340048311403Leksell Stereotactic System100647210064722018-09-21
07340048311793Leksell Stereotactic System Neurosurgical Instruments10756472021-05-31
07340048300087Leksell Stereotactic System10038382016-09-24
07340048300094Leksell Stereotactic System10003492016-09-24
07340048300100Leksell Stereotactic SystemA1200-042016-09-24
07340048300124Leksell Stereotactic System9079992016-09-23
07340048300131Leksell Stereotactic System8111052016-09-23
07340048300148Leksell Stereotactic System10065812016-09-23
07340048300155Leksell Stereotactic System10065842016-09-23
07340048300162Leksell Stereotactic SystemA0227-042016-09-30
07340048300209Leksell Stereotactic System10008102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014221910Galaxy RTiAkesis Inc.IWB2026-05-11
06973682570151CybeRayOur United CorporationIWB2026-04-24
07340201503898Leksell GammaPlanElekta Solutions ABIWB2026-02-04
06974783050023SMD-XGD/AR GalaxyOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-30
06974783050009SMD Galaxy RTxOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-26
07340201502136Leksell GammaPlanElekta Solutions ABIWB2024-02-14
07340201501139Leksell Gamma Knife EspritElekta Solutions ABIWB2023-03-27
07340048311700Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311731Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311755Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311762Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311779Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07540180000238Clarity®Elekta Solutions ABIWB2020-06-19
07340048311878Leksell GammaPlanElekta Instrument ABIWB2020-06-13
07540180000221Clarity®Elekta Solutions ABIWB2020-05-22
05060608880522ISORAD Detector, 1-4MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880539ISORAD Detector, 1-4MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880546ISORAD Detector, 6-12MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880553ISORAD Detector, 6-12MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880560ISORAD Detector, 6-12MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
05060608880577ISORAD Detector, 15-25MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880584ISORAD Detector, 15-25MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880591ISORAD Detector, 15-25MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
07340048306447Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2019-04-17
07540180000214Clarity®Elekta Solutions ABIWB2019-03-27
10850002615361GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615378GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615385GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615392GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615408GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22