Decimal3D

GUDID 00851147007113

3D Scanning and Digitizing Application for Electron Therapy Apertures

DECIMAL, INC.

Radiation therapy software
Primary Device ID00851147007113
NIH Device Record Key4be71d5c-600b-4726-bbba-e6fa64dabc9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDecimal3D
Version Model NumberN/A
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851147007113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUJSystem, Planning, Radiation Therapy Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

Devices Manufactured by DECIMAL, INC.

00851147007144 - .decimal Blocking Tray2023-07-27 Accessory
00851147007113 - Decimal3D2022-12-093D Scanning and Digitizing Application for Electron Therapy Apertures
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.