Clarity®

GUDID 07540180000221

Clarity® Software

Elekta Solutions AB

Ultrasound patient positioning system

• Primary Device ID: 07540180000221
• NIH Device Record Key: 0714bf0f-d1f0-4b58-87b9-6a9d622147ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarity®
• Version Model Number: 9310-00044
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com
• Phone: +1(855)693-5358
• Email: clarity.support@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540180000221 [Primary]

FDA Product Code

• KPQ: System, simulation, radiation therapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-30
• Device Publish Date: 2020-05-22

Devices Manufactured by Elekta Solutions AB

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• 07340201502129 - Leksell Vantage Stereotactic System: 2024-12-09 LEKSELL VANTAGE CARRIER
• 07340201501511 - Leksell Vantage Stereotactic System: 2024-09-09 LEKSELL VANTAGE ARC SYSTEM
• 07340201501887 - Leksell Vantage Stereotactic System: 2024-08-22 LEKSELL VANTAGE ARC SYSTEM
• 07340201501337 - Leksell Vantage Stereotactic System: 2024-08-14 FirmFix™ 5
• 07340201501290 - Leksell Vantage Stereotactic System: 2024-08-13 FirmFix™ 3
• 07340201501313 - Leksell Vantage Stereotactic System: 2024-08-13 FirmFix™ 4