DEXIS™ Software PLU349

GUDID EKAV101034110

US & International

DEXIS LLC

Radiology information system application software

• Primary Device ID: EKAV101034110
• NIH Device Record Key: ed28a2c6-f26e-4af1-862d-3f5a09a97ca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS™ Software
• Version Model Number: 9
• Catalog Number: PLU349
• Company DUNS: 019717844
• Company Name: DEXIS 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: 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: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com
• Phone: +18888833947
• Email: support@dexis.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101034110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090431

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-14

On-Brand Devices [DEXIS™ Software]

• EKAV101135330: Software
• EKAV101034120: Enterprise
• EKAV101034110: US & International
• EKAV101034090: Animal
• EKAV101034080: Forensic
• EKAV101244750: Software