XVI

GUDID 05060191071048

XVI

ELEKTA LIMITED

Radiation therapy digital imager

• Primary Device ID: 05060191071048
• NIH Device Record Key: 8146e92a-2a6f-42a6-92ea-891b58eeb7ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XVI
• Version Model Number: 1526749
• 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	05060191071048 [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