FDA.reportPublic FDA data

Clarity®

Primary DI
07540180000221
Brand
Clarity®
Company
Elekta Solutions AB
Model
9310-00044
Device description
Clarity® Software
Published
2020-05-22
Public version status
Update
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
IYEAccelerator, linear, medical
KPQSystem, simulation, radiation therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWBSystem, Radiation Therapy, RadionuclideRadiology2
IYEAccelerator, Linear, MedicalRadiology2
KPQSystem, Simulation, Radiation TherapyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540180000221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540180000221075401800002217540180000221

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound patient positioning systemAn assembly of devices used to locate, with ultrasound, internal soft-tissue anatomy that moves relative to external or bony landmarks, to enable subsequent adjustment of the patient for precise external beam radiation treatment of the target tissue. It typically includes an ultrasound imaging system, computerized workstation(s), optical tracking devices, and dedicated software.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
353272181
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22