UltraBROKER

GUDID 00860001148572

DICOM Modality Worklist

ULTRARAD CORPORATION

Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 00860001148572
• NIH Device Record Key: 135227cb-72ef-478d-9f06-73dd4f07c219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraBROKER
• Version Model Number: 3.0.2.362
• Company DUNS: 139399021
• Company Name: ULTRARAD CORPORATION
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com
• Phone: 800-527-3779
• Email: sales@ultraradcorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001148572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051813

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-23
• Device Publish Date: 2019-02-13

Devices Manufactured by ULTRARAD CORPORATION

• 00860002319803 - UltraGATEWAY: 2021-04-08 DICOM Router
• 00860001148503 - UltraVISION: 2019-05-23 Clinical image viewer
• 00860001148510 - UltraDISTRIBUTOR: 2019-05-23 Allows sites a methodology to securely deliver electronic results and images to their referring physicians
• 00860001148527 - UltraGATEWAY: 2019-05-23 DICOM Router
• 00860001148534 - UltraARCHIVE: 2019-05-23 DICOM Storage
• 00860001148541 - UltraMEDIA: 2019-05-23 DICOM file import tool
• 00860001148558 - UltraPREFETCH: 2019-05-23 UltraPREFETCH automatically retrieves studies and sends to any DICOM client, on a rule based criteria.
• 00860001148565 - UltraWEB: 2019-05-23 DICOM Viewer