FDA.reportPublic FDA data

EMLA (Elekta EVO)

Primary DI
07340201503461
Brand
EMLA (Elekta EVO)
Company
Elekta Solutions AB
Model
1571644
Device description
Elekta EVO
Published
2026-02-16
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
IYEAccelerator, linear, medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340201503461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340201503461073402015034617340201503461

GMDN Terms#

Term, Definition table
TermDefinition
Linear accelerator systemAn assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.

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
07340201503898Leksell GammaPlan15777562026-02-04
07340201502136Leksell GammaPlan15677142024-02-14
07340201501139Leksell Gamma Knife Esprit11102002023-03-27
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
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
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
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00850065937250eMotusEMPNIA INC.IYE2026-09-21