FDA Registration Active 🇩🇪 Germany

PTW FREIBURG

Reg #: 9681124 · FEI: 3007360740 · Expires 2026
Products
5
Proprietary Names
99
Establishment Types
1
Classifications
5

Registration Details

Registration Name
PTW FREIBURG
Registration Number
9681124
FEI Number
3007360740
Status
Active
Expiry Year
2026
Initial Importer
No
Address
LOERRACHER STRASSE 7
City
FREIBURG Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K972212

Owner / Operator

Firm Name
PTW Freiburg
Operator Number
9010117
Address
Loerracher Strasse 7
City
Freiburg
State
Baden-Wurttemberg
Postal Code
D-79115
Country
DE

US Agent

Business Name
PTW North America Corporation
Contact Name
Rob Morisson
Address
6 Mars Court, Unit 5
City
Boonton
State
NJ
ZIP
07005
Country
US
Phone
937 4041999 ext. 1938

Products

Device Name Product Code
Instrument, Quality-Assurance, Radiologic LHO
Source, Calibration, Sealed, Nuclear IXD
System, Radiation Therapy, Charged-Particle, Medical LHN
Accelerator, Linear, Medical IYE
Phantom, Anthropomorphic, Radiographic IXG

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 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 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 VERIQA RT EPID 3D CT head & body phantom Paediatric filter (multiple) X-Check NORMI HVL filter (multiple) Absorber (multiple) Rigid stem chamber Reference chamber PEAKFINDER Soft X-ray chamber Farmer chamber Roos chamber Bragg peak chamber Markus chamber Advanced Markus chamber T-Ref chamber

Establishment Types

Manufacture Medical Device