Xcelera

GUDID 00884838070646

Philips Xcelera software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital medical images.

Philips Medical Systems Nederland B.V.

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation

• Primary Device ID: 00884838070646
• NIH Device Record Key: ad9563f1-feb5-4a5a-8833-d174dd0d3750
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcelera
• Version Model Number: 4.1
• 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

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838070646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061995

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: 2019-01-17
• Device Publish Date: 2016-12-31

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838122123 - MR-RT: 2024-06-28 MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation
• 00884838112292 - Zenition: 2024-06-05 Zenition 90 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities wh
• 00884838122000 - IntelliSpace Cardiovascular: 2024-05-08 IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians
• 00884838118270 - Philips: 2024-05-02 dS Breast Coil 7ch 1.5T
• 00884838094932 - Zenition 30: 2024-05-01 The Zenition 30 with flat detector is a mobile X-ray imaging and viewing system. It is designed for medical use in healthcare fa
• 00884838123809 - IntelliSpace Radiology: 2024-04-12 IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicia
• 00884838111110 - LumiGuide: 2024-04-01 Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the p
• 00884838111127 - LumiGuide: 2024-04-01 Angiographic guidewire with FORS technology, intended to direct a catheter during navigation in endovascular procedures of the p