Spectral CT

GUDID 00884838101111

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838101111
• NIH Device Record Key: 34ccbadc-bd05-4fde-94c5-5a19f35d1142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectral CT
• Version Model Number: 728333
• 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: false
• 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	00884838101111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203020

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2021-03-19
• Device Publish Date: 2021-03-11

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 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
• 10884838111148 - LumiGuide: 2024-04-01 The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide W
• 00884838117785 - Dunlee: 2024-02-08 1.5T 8CH T/R Knee Coil
• 00884838117761 - Dunlee: 2024-02-02 1.5 T/R Quad Extremity Coil
• 00884838099203 - Azurion: 2023-09-26 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 12-inch flat detector.
• 00884838099210 - Azurion: 2023-09-26 Monoplane Interventional X-Ray System. A floor-mounted monoplane system with a 15-inch flat detector.