EchoGo

GUDID 05060634690027

ULTROMICS LIMITED

Radiology DICOM image processing application software

• Primary Device ID: 05060634690027
• NIH Device Record Key: 747d36f5-7f8c-4ea4-b089-dfa3fcdf2265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoGo
• Version Model Number: Core 2.0
• Company DUNS: 222850684
• Company Name: ULTROMICS 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060634690027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213275

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: 2022-01-27
• Device Publish Date: 2022-01-19

On-Brand Devices [EchoGo]

• 05060634690003: Core
• 05060634690010: Pro
• 05060634690027: Core 2.0
• 05060634690041: Heart Failure 1.0
• 05060634690065: Amyloidosis 1.0
• 05060634690058: Heart Failure 2.0