Clarity®

Basic Information

• Brand Name: Clarity®
• Primary DI: 07540180000214
• Version / Model: 9100-00062
• Company Name: Elekta Solutions AB
• Labeler DUNS: 353272181
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-27
• Public Version: 4
• Public Version Date: 2024-01-01
• Public Version Status: Update
• Public Device Record Key: fc5f89e7-dfad-4f39-8b74-c34c32b9b6e0
• Distribution End Date: 2023-12-31

Device Description

Clarity® TPUS Autoscan Position Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWB	System, radiation therapy, radionuclide	Radiology	892.5750	2
IYE	Accelerator, linear, medical	Radiology	892.5050	2
KPQ	System, simulation, radiation therapy	Radiology	892.5840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45446	Ultrasound patient positioning system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540180000214	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 60 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius