iViewGT™

GUDID 05060191071055

iViewGT

ELEKTA LIMITED

Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager

• Primary Device ID: 05060191071055
• NIH Device Record Key: f877d508-651b-4fbb-89d1-87b2878a7d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iViewGT™
• Version Model Number: 1526752
• Company DUNS: 525557559
• Company Name: ELEKTA LIMITED
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060191071055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012289

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by ELEKTA LIMITED

• 05060191071468 - Elekta Unity: 2021-12-08 CT OVERLAY
• 05060191071482 - Elekta Unity: 2021-12-08 Indexing Bar
• 05060191071499 - Elekta Unity: 2021-12-08 Indexing Bars
• 05060191071598 - Elekta Unity: 2021-12-08 Elekta Unity
• 05060191071345 - Integrity™: 2020-01-20 Integrity
• 05060191071420 - Elekta Unity: 2019-05-08 INDEXING BAR
• 05060191071437 - Elekta Unity: 2019-05-08 INDEXING BARS
• 05060191071321 - Elekta Unity: 2019-02-25 Elekta Unity