Philips 459801419352

GUDID 00884838091122

Pinnacle3 Radiation therapy treatment planning system version 16.2.1.60098

Philips Medical Systems (cleveland), Inc.

Radiation therapy software

• Primary Device ID: 00884838091122
• NIH Device Record Key: 9fc72ed9-ed46-49cc-a839-2d2de44c1137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips
• Version Model Number: 459801419352
• Catalog Number: 459801419352
• Company DUNS: 829526560
• Company Name: Philips Medical Systems (cleveland), 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: 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	00884838091122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170086

FDA Product Code

• MUJ: System, planning, radiation therapy treatment

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: 2020-03-06
• Device Publish Date: 2020-02-27

On-Brand Devices [Philips]

• 00884838098992: Pinnacle Radiation Therapy Planning System Version 16.4.0.60093
• 00884838091122: Pinnacle3 Radiation therapy treatment planning system version 16.2.1.60098
• 00884838085602: Pinnacle Radiation Therapy Planning System Version 16.0.1.60003
• 00884838074200: Pinnacle Radiation Therapy Planning System Version 16.0.0.60013