FDA.report

Leksell Gamma Knife Perfexion

Primary DI
07340048306171
Brand
Leksell Gamma Knife Perfexion
Company
Elekta Instrument AB
Model
1001182
Device description
QA TOOL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IWBSystem, radiation therapy, radionuclide

Product Code Classifications

CodeDeviceSpecialtyClass
IWBSystem, Radiation Therapy, RadionuclideRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07340048306171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07340048306171073400483061717340048306171

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)693-5358info.america@elekta.com

Regulatory Flags

DUNS number
507772663
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07340048311892Leksell Vantage Stereotactic System15515812020-06-16
07340048311793Leksell Stereotactic System Neurosurgical Instruments10756472021-05-31
07340048312011Leksell Vantage Stereotactic System10985282021-03-30
07340048311700Leksell Gamma Knife Perfexion/Icon10752422021-03-28
07340048311731Leksell Gamma Knife Perfexion/Icon10752332021-03-28
07340048311755Leksell Gamma Knife Perfexion/Icon10752462021-03-28
07340048311762Leksell Gamma Knife Perfexion/Icon10801312021-03-28
07340048311779Leksell Gamma Knife Icon10752512021-03-28
07340048311953Leksell Vantage Stereotactic System10985322021-03-28
07340048311977Leksell Vantage Stereotactic System10985342021-03-28
07340048311991Leksell Vantage Stereotactic System10985302021-03-28
07340048305112Leksell Gamma Knife Perfexion/Icon10026372020-10-09
07340048311373Leksell Vantage Stereotactic System107244710724472019-09-10
07340048304566Leksell Gamma Knife Icon15289482016-09-23
07340048304610Leksell Gamma Knife Icon15267782016-09-23
07340048304634Leksell Gamma Knife Icon15267772016-09-23
07340048304917Leksell Gamma Knife Icon153974410307582018-09-16
07340048304924Leksell Gamma Knife Icon15244112016-09-24
07340048311434Leksell Vantage Stereotactic System107292810729282019-09-10
07340048311458Leksell Vantage Stereotactic System107292210729222019-09-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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 Instrument ABIWB2021-03-28
07340048311731Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2021-03-28
07340048311755Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2021-03-28
07340048311762Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2021-03-28
07340048311779Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07340048306447Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2019-04-17
07540180000214Clarity®Elekta LtdIWB2019-03-27
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
10850002615415GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615422GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615439GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615446GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615453GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615088GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21
10850002615095GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21
10850002615101GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21
10850002615118GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21
10850002615125GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21
10850002615132GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21
10850002615149GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21
10850002615156GammaPod™ Breast Immobilization and Localization SXCISION MEDICAL SYSTEMS, LLCIWB2019-03-21