FDA.reportPublic FDA data

PQASoft

Primary DI
EPTWS0700300
Brand
PQASoft
Company
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Model
PQASoft 1.x
Catalog number
S070030
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K160405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160405000OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4DPtw-Freiburg Physikalisch-Technische-Werkstaetten2017-10-20IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPTWS0700300PrimaryHIBCC0

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
318749751
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPTWS070031Q5200VERIQAVERIQA RT MonteCarlo 3D v3S070031.5202026-04-17
EPTWT20020Q1Q1000COUCHFIXCOUCHFIX Locating bar VarianT20020.1.1002026-04-16
EPTWT20020Q1Q1100COUCHFIXCOUCHFIX Locating bar ElektaT20020.1.1102026-04-16
EPTWT20020Q1Q1300COUCHFIXCOUCHFIX Locating bar MRIdianT20020.1.1302026-04-16
EPTWT20020Q1Q2000COUCHFIXCOUCHFIX RUBY PhantomT20020.1.2002026-04-16
EPTWT20020Q1Q3000COUCHFIXCOUCHFIX OCTAVIUS 4D PhantomT20020.1.3002026-04-16
EPTWT20020Q1Q3100COUCHFIXCOUCHFIX OCTAVIUS DetectorT20020.1.3102026-04-16
EPTWT20020Q1Q4000COUCHFIXCOUCHFIX QUICKCHECKT20020.1.4002026-04-16
EPTWT41018Q1Q0100MP1 Manual Water PhantomMP1 Reference Detector HolderT41018.1.0102026-04-16
EPTWT41018Q1Q0120MP1 Manual Water PhantomMP1 Plug HolderT 41018.1.0122026-04-16
EPTWT41019Q1Q0040MP1 Manual Water PhantomMP1 Detector Holder 7 mmT41019.1.0042026-04-16
EPTWT41019Q1Q0050MP1 Manual Water PhantomMP1 Detector Holder FarmerT41019.1.0052026-04-16
EPTWT41019Q1Q0060MP1 Manual Water PhantomMP1 Detector Holder Advanced MarkusT41019.1.0062026-04-16
EPTWT41019Q1Q0070MP1 Manual Water PhantomMP1 Detector Holder RoosT41019.1.0072026-04-16
EPTWT41019Q1Q0120MP1 Manual Water PhantomMP1 Detector Holder Bragg-Peak 10.5 cm³T41019.1.0122026-04-16
EPTWT410250MP1 Manual Water PhantomMP1 Manual Water PhantomT410252026-04-16
EPTWT410330MP1 Manual Water PhantomMP1 Manual Water Phantom, Extra LinesT410332026-04-16
EPTWT410520MP1 Manual Water PhantomMP1 Manual Water Phantom MRT410522026-04-16
EPTWT110620DIAMENTORDIAMENTOR RS-KDK, Version RS232T110622026-04-15
EPTWT110640DIAMENTORDIAMENTOR RS-KDK, Version RS485T110642026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
EPTWTM600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTW600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTW600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15