EchoNavigator 001011

GUDID 00884838080737

Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software

• Primary Device ID: 00884838080737
• NIH Device Record Key: d7adee38-a39c-48b2-9468-490f9e7d0e56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoNavigator
• Version Model Number: EchoNavigator R3
• Catalog Number: 001011
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838080737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121781

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: 7
• Public Version Date: 2020-01-13
• Device Publish Date: 2017-09-13

On-Brand Devices [EchoNavigator]

• 00884838080737: Software medical device. Assists the interventionalist and surgeon with image guidance during tr
• 00884838059283: Software medical device. Assists the interventionalist and surgeon with image guidance during tr
• 00884838106437: Software medical device. Assists the interventionalist and surgeon with image guidance during tr