Allura 3D-CA 001009

GUDID 00884838059245

Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run.

Philips Medical Systems Nederland B.V.

Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software Angiographic x-ray system application software

• Primary Device ID: 00884838059245
• NIH Device Record Key: d608ca57-210f-4e14-9a15-242abfd2f281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allura 3D-CA
• Version Model Number: Allura 3D-CA R3
• Catalog Number: 001009
• 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	00884838059245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042334

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: 6
• Public Version Date: 2019-10-24
• Device Publish Date: 2016-09-24

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