Data / Medical devices / Germany / PTW Freiburg
PTW Freiburg: FDA-registered device maker in FREIBURG Baden-Wurttemberg, Germany, 11 510(k) clearances
PTW Freiburg is registered with the FDA (registration 9681124) in FREIBURG Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 15, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681124
- FEI number
- 3007360740
- Address
- Loerracher Strasse 7, FREIBURG Baden-Wurttemberg, Germany, D-79115
- Owner or operator
- PTW Freiburg (9010117)
- Roles
- Manufacturer
- First device listed
- April 5, 1994
- Registered through
- 2026
- Brand names listed
- Absorber (multiple), Acrylic/RW3 slab phantoms and plates, multiple, Advanced Markus chamber, BEAMSCAN, BEAMSCAN MR, BQ-CHECK, BeamAdjust, Bragg peak chamber and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Radiographic | IXG | 1 | Manufacturer | accessdata.fda.gov |
| Source, Calibration, Sealed, Nuclear | IXD | 1 | Manufacturer | accessdata.fda.gov |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2026 | K252258 | VERIQA RT EPID 3D | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | accessdata.fda.gov |
| March 30, 2022 | K213370 | VERIQA | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | accessdata.fda.gov |
| February 21, 2020 | K191646 | Beamscan MR | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | accessdata.fda.gov |
| October 20, 2017 | K160405 | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | accessdata.fda.gov |
| May 19, 2017 | K161807 | BEAMSCAN | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch Technische-Werksraetten | accessdata.fda.gov |
| June 20, 2001 | K010916 | PTW DOSIMETRY DIODE, T60008 | IYE | Substantially Equivalent | Ptw-New York Corp. | accessdata.fda.gov |
| September 10, 1997 | K972212 | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER | LHN | Substantially Equivalent | Ptw-New York Corp. | accessdata.fda.gov |
| September 10, 1997 | K972211 | MULTIDOS, QC6PLUS | LHN | Substantially Equivalent | Ptw-New York Corp. | accessdata.fda.gov |
| June 17, 1996 | K961208 | 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER | IYE | Substantially Equivalent | Ptw-New York Corp. | accessdata.fda.gov |
| December 5, 1995 | K954165 | PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM | IYE | Substantially Equivalent | Ptw-New York Corp. | accessdata.fda.gov |
| October 7, 1995 | K951764 | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR | IYE | Substantially Equivalent | Ptw-New York Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 4, 2026 | 99720 | Class II | Ongoing | Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18 | When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth. | accessdata.fda.gov |
| February 8, 2024 | 93988 | Class II | Ongoing | Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. | Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold (Suppress gamma calculation), the Gamma Passing Rate (GPR) calculated for individual ROIs is not correct. The GPR calculated by VERIQA overestimates the correct GPR. The evaluation can therefore show false positive results. | accessdata.fda.gov |
| June 7, 2023 | 92879 | Class II | Ongoing | BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 | Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file. | accessdata.fda.gov |
| May 27, 2015 | 71395 | Class II | Terminated | PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics. | In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-expos | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of System, Radiation Therapy, Charged-Particle, Medical
- All makers of Phantom, Anthropomorphic, Radiographic
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Source, Calibration, Sealed, Nuclear
Updated September 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.