EVOLVE

GUDID G775EVOLVE0

Picture archiving and communication system (PACS) software that retrieves, archives, distributes, and displays images and data from all common modalities.

Smaart Medical Systems, Inc.

Radiological PACS software

• Primary Device ID: G775EVOLVE0
• NIH Device Record Key: b70a2dd8-ed55-43e5-a3f4-4618d3de7a3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLVE
• Version Model Number: 4.1.2
• Company DUNS: 143044274
• Company Name: Smaart Medical Systems, Inc.
• 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

Customer Support Contacts

• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net
• Phone: 972-934-4600
• Email: kim.terry@smaart.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G775EVOLVE0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211863

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2025-06-23
• Device Publish Date: 2025-06-13

On-Brand Devices [EVOLVE]

• G775EVOLVE0: Picture archiving and communication system (PACS) software that retrieves, archives, distributes
• G775EVOLVE4130: Picture archiving and communication system (PACS) software that retrieves, archives, distributes