StatPACS

GUDID 00860257001102

StatPACS is a software based PACS product, intended to be used by radiologists, technologists and clinicians to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPACS software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis.

NUCLEUSHEALTH, LLC

Diagnostic imaging telemedicine system

• Primary Device ID: 00860257001102
• NIH Device Record Key: 24333cda-15e9-4342-8b42-c1ddd10861b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatPACS
• Version Model Number: 1000
• Company DUNS: 962160813
• Company Name: NUCLEUSHEALTH, LLC
• 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

Customer Support Contacts

• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com
• Phone: 858-546-3800
• Email: info@statrad.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860257001102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092134

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: 2024-08-05
• Device Publish Date: 2024-07-26