AltaTrack equipment

GUDID 00884838099340

The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available. The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

Philips Medical Systems Nederland B.V.

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 00884838099340
• NIH Device Record Key: 5ebde41b-18e5-45ce-aae7-4cb1745186d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AltaTrack equipment
• Version Model Number: 4322 070 2535
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838099340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201081

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2021-01-29
• Device Publish Date: 2021-01-21

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838121263 - Philips IntelliSite Pathology Solution: 2025-03-04 Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system.
• 00884838127609 - DUNLEE SENTINELLE: 2025-01-20 ADD-ON ACCESSORIES BREAST SEN MR SET contains - 2 Fiducial Marker Grid Block Assembly and 1 BREAST GRID (USER STERILIZED)
• 00884838119277 - Philips Sentinelle: 2024-12-25 dS 1.5T Interface Box
• 00884838119284 - Philips Sentinelle: 2024-12-25 dS 3.0T Interface Box
• 00884838119291 - Philips Sentinelle: 2024-12-25 dS 1.5T 8CH Medial
• 00884838119307 - Philips Sentinelle: 2024-12-25 dS 3.0T 8CH Medial
• 00884838119314 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Left
• 00884838119321 - Philips Sentinelle: 2024-12-25 dS 3.0T 4CH Lateral Left