FDA.reportPublic FDA data

FilmQA Pro

Primary DI
00850000065000
Brand
FilmQA Pro
Company
ASHLAND SPECIALTY INGREDIENTS G.P.
Model
7.0
Catalog number
N/A
Device description
Radiation/Radiology Software
Published
2021-09-23
Public version status
Update
Distribution status
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
00850000065000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000065000008500000650008500000650000850000065000

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152728887
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810106410951Gafchromic™EBT4 1.3x2 @300SH9933212026-04-14
00810106411279Gafchromic™EBT-4 ZAP CAL STRIP @12SH 9951202026-03-26
00810106411040Gafchromic™EBT-4 CIRS STEEV @ 20SH 9951192026-03-02
00810106411057Gafchromic™EBT-4 ZAP CAL STRIP @12SH 9952102026-03-02
00810106411064Gafchromic™EBT-XD RBY @ 50SH9949582026-03-02
00810106411071Gafchromic™EBT-4 35MM @ 100SH9950532026-03-02
00810106411088Gafchromic™EBT-4 18 MM @ 100SH9950522026-03-02
00810106411095Gafchromic™MD-V3 1.3X2 @200SH9933002026-03-02
00810106411101Gafchromic™HD-V2 1.3x2 @50SH9933172026-03-02
00810106411118Gafchromic™1.3X2 @300SH9933212026-03-02
00810106410807Gafchromic™Pnt-Dos™ Device9879612025-02-13
00810106410845FilmQA Pro8.09879572025-02-12
00810106410937Gafchromic™ThorX Rod Film @59904412025-01-28
00810106410944Gafchromic™ThorX Spine Film Insert @59904422025-01-28
00810106410920Gafchromic™EBT4-XD Lucy-EA Multi @69893962024-12-30
00810106410883Gafchromic™EBT4 Lucy-EA Multi @69893962024-10-25
00810106410913Gafchromic™EBT4 Disc Gyro @209894052024-11-21
00810106410906Gafchromic™HD-V2 IO 22685-2 @ 50SH9894112024-11-11
00810106410869Gafchromic™EBT-XD Lucy Ortho @19893942024-10-25
00810106410876Gafchromic™EBT4 Lucy-EA Cal Strip9893952024-10-25

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
B9875X10Radiochromic.comRADIOCHROMIC SL.MWW2024-06-10
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
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