Lvivo Seamless

GUDID 07290019352020

DIA IMAGING ANALYSIS LTD

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• Primary Device ID: 07290019352020
• NIH Device Record Key: d5312210-5ac4-4510-9d17-f2120a1a532c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lvivo Seamless
• Version Model Number: Lvivo_Seamless
• Company DUNS: 533365149
• Company Name: DIA IMAGING ANALYSIS LTD
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019352020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202546

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-08
• Device Publish Date: 2022-08-31

Devices Manufactured by DIA IMAGING ANALYSIS LTD

• 07290019352006 - Lvivo Software Application Platform: 2022-09-08
• 07290019352013 - Lvivo Mobile: 2022-09-08
• 07290019352020 - Lvivo Seamless: 2022-09-08
• 07290019352020 - Lvivo Seamless: 2022-09-08
• 07290019352037 - Lvivo Standalone UI: 2022-09-08