FDA.reportPublic FDA data

ThinkQA, EPIbeam

Primary DI
B501THINKQA010004
Brand
ThinkQA, EPIbeam
Company
DOSISOFT
Model
1.0.4
Catalog number
1.0.4
Device description
Radiation therapy quality assurance and error detection software suite
Published
2019-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180106000ThinkQADosisoft2018-03-13IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B501THINKQA010004PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
264815932
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B501PLANET030200PLANET Onco Dose3.2PL11002025-07-17
B501THINKQA0200020ThinkQA Edition 22.0.22024-08-22
B501THINKQA0200000ThinkQA Edition 22.0.0TK2010, TK20202024-08-14
B501THINKQA0200010ThinkQA Edition 22.0.1TK2010, TK20202024-08-14
B501EPIGRAY020010EPIgray2.0.10EP10012023-06-30
B501THINKQA010006ThinkQA, EPIbeam1.0.6EP10112023-06-30
B501PLANET030101PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose3.1.13.1.12020-01-30
B501MU2NET020101MU2net2.1.12.1.12019-11-19
B501EPIGRAY020007EPIgray2.0.72.0.72019-08-07
B501EPIGRAY020006EPIgray2.0.62.0.62017-04-10
B501THINKQA010002ThinkQA, EPIbeam1.0.21.0.22018-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.IYE2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.IYE2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.IYE2026-04-22
08720168160140DSPS-Prominent® baseplate MACROMEDICS B.V.IYE2026-04-21
08720168162557DSPS-Prominent® Cradle-IMACROMEDICS B.V.IYE2026-04-21