FDA.reportPublic FDA data

Leksell Gamma Knife Perfexion

Primary DI
07340048303019
Brand
Leksell Gamma Knife Perfexion
Company
Elekta Solutions AB
Model
715000
Device description
LEKSELL GAMMA KNIFE PERFEXION
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
07340048303019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340048303019073400483030197340048303019

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
353272181
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07340201502440Leksell Stereotactic System104032110403212025-09-17
07340201502921Leksell Stereotactic System10404991040319 2025-09-17

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
07340048311786Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
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