.decimal Photon Compensator

GUDID 00851147007052

A custom manufactured solid filters for missing tissue and intensity modulation for external beam radiation therapy.

DECIMAL, INC.

Radiation therapy beam block material
Primary Device ID00851147007052
NIH Device Record Key62925013-c305-49ed-a4a5-770586adee2a
Commercial Distribution StatusIn Commercial Distribution
Brand Name.decimal Photon Compensator
Version Model Number1.0
Company DUNS617041967
Company NameDECIMAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851147007052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IXIBlock, Beam-Shaping, Radiation Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by DECIMAL, INC.

00851147007144 - .decimal Blocking Tray2023-07-27 Accessory
00851147007113 - Decimal3D2022-12-09 3D Scanning and Digitizing Application for Electron Therapy Apertures
00851147007137 - decimal Bolus (FlexiBol)2022-12-09 decimal Silicone Bolus
00851147007120 - .decimal Astroid Planning App 3.x2022-12-01 The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
00851147007007 - .decimal Proton Aperture2018-07-06 .decimal Proton Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is custom and unique
00851147007014 - .decimal Proton Range Compensator2018-07-06 Custom manufactured solid Range Compensators for intensity modulation of external beam proton radiation therapy.
00851147007021 - .decimal Electron Bolus2018-07-06 A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy.
00851147007038 - .decimal Electron Aperture2018-07-06 A custom made device that shapes and focuses the electron beam aimed at the cancerous tissue.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.