PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose 3.1.1

GUDID B501PLANET030101

PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.

DOSISOFT

Radiation therapy software

• Primary Device ID: B501PLANET030101
• NIH Device Record Key: 01d4e834-568d-4d18-a660-a3d8d2646868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose
• Version Model Number: 3.1.1
• Catalog Number: 3.1.1
• Company DUNS: 264815932
• Company Name: DOSISOFT
• 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: 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
HIBCC	B501PLANET030101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182966

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-02-07
• Device Publish Date: 2020-01-30

Devices Manufactured by DOSISOFT

• B501EPIGRAY020010 - EPIgray: 2023-07-10 Radiotherapy quality assurance software tool.
• B501THINKQA010006 - ThinkQA, EPIbeam: 2023-07-10 Radiation therapy quality assurance and error detection software suite.
• B501PLANET030101 - PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose: 2020-02-07PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.
• B501PLANET030101 - PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose: 2020-02-07 PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radi
• B501MU2NET020101 - MU2net: 2019-11-27 MU2net is a standalone software device designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Pla
• B501EPIGRAY020006 - EPIgray: 2018-07-06 Radiotherapy software quality assurance tool.
• B501THINKQA010002 - ThinkQA, EPIbeam: 2018-07-06 Radiation therapy quality assurance and error detection software suite