FDA.reportPublic FDA data

NA

Primary DI
EPTWS0700160
Brand
NA
Company
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Model
DAVID software
Catalog number
S070016
Published
2017-04-25
Public version status
Update
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
K062817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062817000PTW DAVID IMRT QC VERIFICATION SYSTEMPtw-New York Corp.2006-11-22IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPTWS0700160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality therapeutic radiation phantom, anthropomorphicA device consisting of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is available in both fixed and variable designs and typically include holders for ionization chambers, dosimeters or radiation measurement instruments. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used for quantitative and subjective assessments of the performance of a radiation therapy treatment planning system (RTTPS) and therapeutic radiation delivery systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
318749751
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
EPTWS0700300PQASoftPQASoft 1.xS0700302026-04-15
EPTWT110620DIAMENTORDIAMENTOR RS-KDK, Version RS232T110622026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
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