Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681124

FEI Number

3007360740

Entity Name

PTW FREIBURG

City/State/Country

FREIBURG Baden-Wurttemberg, DE

Establishment Address

LOERRACHER STRASSE 7, FREIBURG Baden-Wurttemberg D-79115, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PTW Freiburg (Owner Number: 9010117)

Owner / Operator Contact Address

Loerracher Strasse 7, Freiburg, DE-BW D-79115, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160405

PMA Number

N/A

All Registered Proprietary Names

DIAVOLT CONNY II DIADOS CT ion chamber SFD ion chamber Track-it Acrylic/RW3 slab phantoms and plates, multiple WEDGECHECK EPID QC ISOBALL POSICHECK MONICHECK FIELDCHECK CT phantom IMRT phantom Mounting plates, multiple OCTAVIUS phantom BQ-CHECK ESTRO Mini-Phantom PET/SPECT phantom Holding devices, multiple QUICKCHECK Inhomogeneity phantom OCTAVIUS accessories, multiple TRUFIX LINACHECK NOMEX DIAMENTOR STARCHECK ISOCHECK epid ISOCHECK COUCHFIX RUBY MP1 Manual Water Phantom, multiple OCTAVIUS 4D Phantom MR RADIOACTIVE CHECK SOURCE PinPoint chamber PinPoint 3D Semiflex chamber Semiflex 3D PinPoint 3D MR Semiflex 3D MR Dosimetry Diode micro DIAMOND microSilicon X microSilicon VERIQA RT MonteCarlo 3D VERIQA QUICKCHECK MULTIDOS UniSoft UNIDOS E UNIDOS webline UNIDOS Romeo UNIDOS Tango MP3-T Water Phantom MP1 Acrylic Water Tank TBA Control Pendant MP2 Acrylic Water Tank MEPHYSTO SCANLIFT MP3-XS Water Phantom MP3-P45 Water Phantom Linear Array LA48 MP3 Water Phantom MP3-P Water Phantom MP3-M Water Phantom SLA48 2D-Air Scanner TBA Control Unit Stationary water phantom MP1 Water Phantom TRUFIX BEAMSCAN BEAMSCAN MR OCTAVIUS detector, multiple MultiCheck OCTAVIUS Control Unit VeriSoft Detector Interface OCTAVIUS I, II, III, 4D OCTAVIUS Rotation Unit BeamAdjust Inclinometer PQA Soft OCTAVIUS detector MR, multiple

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	1994-04-05
IXD	Source, Calibration, Sealed, Nuclear	Radiology	Class 1	892.1400	2003-07-02
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2016-07-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2016-07-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2022-05-01
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2016-07-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2016-07-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2016-07-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2017-05-23
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2020-03-09
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-05-09

Official Correspondent

No official correspondent registered.

US Agent Details

Rob Morisson Business: PTW North America Corporation Email: rob.morrison@ptwdosimetry.com Phone: (937) 4041999

Related Public Records

Same Entity

PTW Freiburg

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2009	Intraop Medical Corporation	2	Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681124. Last updated year: 2026. Please use registration number 9681124 when referencing this establishment in official correspondence.