IntelliSpace PACS 837507

GUDID 00884838074781

IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Philips Healthcare Informatics, Inc.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838074781
• NIH Device Record Key: 03eba5e3-302a-4b69-ae05-cffa2c11301c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace PACS
• Version Model Number: 4.x
• Catalog Number: 837507
• Company DUNS: 095471327
• Company Name: Philips Healthcare Informatics, Inc.
• 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

Customer Support Contacts

• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838074781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111804

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: 4
• Public Version Date: 2019-02-05
• Device Publish Date: 2016-09-24

Devices Manufactured by Philips Healthcare Informatics, Inc.

• 00884838091740 - IntelliSpace Radiology: 2019-03-11 IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not l
• 00884838074781 - IntelliSpace PACS: 2019-02-05IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
• 00884838074781 - IntelliSpace PACS: 2019-02-05 IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physi
• 00884838091849 - IntelliSpace Clinical Applications: 2018-10-31 Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC ha