Clarity®

GUDID 07540180000221

Clarity® Software

Elekta Solutions AB

Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system Ultrasound patient positioning system 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

• 07340201500057 - ProKnow DS: 2024-03-29
• 07340201502136 - Leksell GammaPlan: 2024-02-22 Leksell GammaPlan
• 07540180000221 - Clarity®: 2023-06-30Clarity® Software
• 07540180000221 - Clarity®: 2023-06-30 Clarity® Software
• 07340201500064 - Monaco: 2023-04-12
• 07340201500071 - MOSAIQ: 2023-04-12
• 07340201501139 - Leksell Gamma Knife Esprit: 2023-04-04 Elekta Esprit
• 07340201500033 - Monaco: 2022-07-19
• 07340201500040 - AATMA: 2022-03-17