S070016

GUDID EPTWS0700160

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

Multi-modality therapeutic radiation phantom, anthropomorphic
Primary Device IDEPTWS0700160
NIH Device Record Key94f2ade3-2e90-4674-ad5f-2f70af9685c6
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDAVID software
Catalog NumberS070016
Company DUNS318749751
Company NamePTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEPTWS0700160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-25

Devices Manufactured by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH

EPTWS070031 - VERIQA2024-02-16 VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in ra
EPTWT100560 - OCTAVIUS2023-12-07
EPTWT100570 - OCTAVIUS2023-12-07
EPTWT100580 - OCTAVIUS2023-12-07
EPTWS0700160 - NA2018-07-06
EPTWS0700160 - NA2018-07-06
EPTWS1000090 - NA2018-07-06
EPTWT100040 - MULTIDOS2018-07-06
EPTWT100060 - NA2018-07-06

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