Navigo™ Workstation FPRMC0016A

GUDID 07290016936001

UC-CARE LTD

Rectal ultrasound navigational image processor

• Primary Device ID: 07290016936001
• NIH Device Record Key: ac264912-e4f7-4d6a-b4d7-fad176d2f614
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigo™ Workstation
• Version Model Number: FPRMC0016A
• Catalog Number: FPRMC0016A
• Company DUNS: 649551124
• Company Name: UC-CARE LTD
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016936001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100784

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: 2017-11-15

Devices Manufactured by UC-CARE LTD

• 07290016936001 - Navigo™ Workstation: 2018-07-06
• 07290016936001 - Navigo™ Workstation: 2018-07-06
• 07290016936018 - Computer (Industrial): 2018-07-06
• 07290016936025 - Probe sensor assembly for BK 8808 (square): 2018-07-06
• 07290016936032 - Probe sensor assembly for BK 8818 and 8808e (squar: 2018-07-06
• 07290016936049 - Probe sensor assembly for Hitachi V53W (square): 2018-07-06
• 07290016936056 - Probe sensor assembly for GE E8CS (square): 2018-07-06
• 07290016936063 - Probe sensor assembly for BK 8667 (square): 2018-07-06
• 07290016936070 - Probe sensor assembly for MindRay: 2018-07-06