PCR ELEVA 732050

GUDID 00884838004047

System Image Processing, Radiological

Philips Medical Systems DMC GmbH

Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner Computed radiography digital imaging scanner

• Primary Device ID: 00884838004047
• NIH Device Record Key: 9e009d17-e903-4515-813f-ccc4653b8f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCR ELEVA
• Version Model Number: 9890-010-83731
• Catalog Number: 732050
• Company DUNS: 314101218
• Company Name: Philips Medical Systems DMC GmbH
• 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: true
• 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	00884838004047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093355

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: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-19

On-Brand Devices [PCR ELEVA]

• 00884838074569: System Image Processing, Radiological
• 00884838004047: System Image Processing, Radiological