Image Management 839060

GUDID 00884838107557

Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.

Philips Medical Systems Nederland B.V.

Radiological PACS software

• Primary Device ID: 00884838107557
• NIH Device Record Key: fd8e6e8b-fa57-439e-b08f-f8964fd108f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image Management
• Version Model Number: 15.X
• Catalog Number: 839060
• 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: 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	00884838107557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240822

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2024-11-25
• Device Publish Date: 2024-11-15

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 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
• 00884838119338 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Right