Ingenuity Flex

GUDID 00884838059528

Philips Medical Systems (cleveland), Inc.

Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system Full-body CT system

• Primary Device ID: 00884838059528
• NIH Device Record Key: 5ed43704-31a5-4ef6-b58b-5bdbacc1e7cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenuity Flex
• Version Model Number: 728317
• Company DUNS: 001224989
• 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: 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	00884838059528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033326

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-15
• Device Publish Date: 2016-09-23

Devices Manufactured by Philips Medical Systems (cleveland), Inc.

• 00884838102965 - Pinnacle Radiation Therapy Planning System: 2021-08-06
• 00884838103566 - Pinnacle Radiation Therapy Planning System: 2021-08-06
• 00884838074200 - Philips: 2020-03-06 Pinnacle Radiation Therapy Planning System Version 16.0.0.60013
• 00884838085602 - Philips: 2020-03-06 Pinnacle Radiation Therapy Planning System Version 16.0.1.60003
• 00884838091122 - Philips: 2020-03-06 Pinnacle3 Radiation therapy treatment planning system version 16.2.1.60098
• 00884838098992 - Philips: 2020-03-06 Pinnacle Radiation Therapy Planning System Version 16.4.0.60093
• 00884838059528 - Ingenuity Flex: 2019-07-15
• 00884838059528 - Ingenuity Flex: 2019-07-15
• 00884838059443 - Ingenuity TF: 2018-07-06