IntelliSpace Radiology 836344

GUDID 00884838091740

IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography.

Philips Healthcare Informatics, Inc.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838091740
• NIH Device Record Key: 5dcd3f11-b217-4a9a-a0bd-f6afb45d0461
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntelliSpace Radiology
• Version Model Number: 4.x
• Catalog Number: 836344
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838091740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182926

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: 2019-03-11
• Device Publish Date: 2019-03-01

Devices Manufactured by Philips Healthcare Informatics, Inc.

• 00884838091740 - IntelliSpace Radiology: 2019-03-11IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography.
• 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: 2019-02-05 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