FDA.reportPublic FDA data

Radiochromic.com

Primary DI
B9875X10
Brand
Radiochromic.com
Company
RADIOCHROMIC SL.
Model
5.1
Device description
Radiochromic film dosimetry and radiation therapy QA software
Published
2024-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MWWAccessory - Film Dosimetry System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWWAccessory - Film Dosimetry SystemRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B9875X10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system quality assurance deviceAn instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
468141103
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B9876X00Radiochromic.com6.02025-12-09
B9875X00Radiochromic.com5.02023-12-10
B9874X00Radiochromic.com4.02022-04-08
B9873X40Radiochromic.com3.42021-09-11
B9873X30Radiochromic.com3.32020-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B9876X00Radiochromic.comRADIOCHROMIC SL.MWW2025-12-09
00810106410845FilmQA ProASHLAND SPECIALTY INGREDIENTS G.P.MWW2025-02-12
B9875X00Radiochromic.comRADIOCHROMIC SL.MWW2023-12-10
00866562000274Standard Imaging RAy SoftwareSTANDARD IMAGING INC.MWW2023-06-22
04042761006897OlympusOLYMPUS Winter & Ibe GmbHMWW2023-01-27
B9874X00Radiochromic.comRADIOCHROMIC SL.MWW2022-04-08
00850000065000FilmQA ProASHLAND SPECIALTY INGREDIENTS G.P.MWW2021-09-23
B9873X40Radiochromic.comRADIOCHROMIC SL.MWW2021-09-11
B9873X30Radiochromic.comRADIOCHROMIC SL.MWW2020-10-21
00866498000300RayAGILE RADIOLOGICAL TECHNOLOGIESMWW2017-10-02
EIBAE60200100MatriXX PT kalibriertIBA Dosimetry GmbHMWW2016-09-09
EIBAM10136410DigiPhant IBA Dosimetry GmbHMWW2016-09-09