XVI

GUDID 05060191071116

XVI Cassette M15

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: 05060191071116
• NIH Device Record Key: a33043c5-0c71-4897-b708-a85c147eb5eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVI
• Version Model Number: 1526911
• 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	05060191071116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131965

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

On-Brand Devices [XVI]

• 05060191071208: XVI Cassette F0
• 05060191071192: XVI Cassette M10
• 05060191071185: XVI Cassette L20
• 05060191071178: XVI Cassette M20
• 05060191071161: XVI Cassette S20
• 05060191071154: XVI Cassette L2
• 05060191071147: XVI Cassette M2
• 05060191071130: XVI Cassette L10
• 05060191071123: XVI Cassette F1
• 05060191071116: XVI Cassette M15
• 05060191071109: XVI Cassette S10
• 05060191071093: XVI Cassette 15x15
• 05060191071048: XVI