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
- [email protected]
- Phone
- 937 4041999 ext. 1938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 1994-04-05 |
| Source, Calibration, Sealed, Nuclear | IXD | Class 1 | Radiology | No | 2003-07-02 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2016-07-25 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2016-07-25 |
| Phantom, Anthropomorphic, Radiographic | IXG | Class 1 | Radiology | No | 2015-02-12 |
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