Search Results
Found 4 results
510(k) Data Aggregation
K Number
K232738Device Name
BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
Date Cleared
2024-05-31
(267 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BeamDose is a software for the following purposes in radiotherapy:
- absolute dose measurements as field class dosemeter (according to IEC 60731)
- monitor calibration
- positioning of detectors in PTW water phantoms
The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.
The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results.
Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.
The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel.
The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
Device Description
The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values.
The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms.
The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters.
The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor.
The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.
Ask a Question
Ask a specific question about this device
K Number
K213370Device Name
VERIQA
Date Cleared
2022-03-30
(169 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PTW-Freiburg Physikalisch-Technische-Werkstaetten
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
VERIQA software is a tool for evaluation and data management of digital images and treatment plan information. It supports the medical imaging modalities CT, MR, PET according to the ACR/NEMA DICOM 3.0 standard and other modalities. VERIQA supports the following applications:
- a) Receiving, transmitting, storing, display, and processing of medical images and DICOM objects.
- b) Creating, displaying and printing of reports containing medical images.
- c) Image registration, fusion display, and review of medical images for treatment evaluation and treatment planning.
- d) Localization and definition of structures such as tumors and normal tissue in medical image sets.
- e) Creation, transfer, and modification of contours and dose distributions such as quantitative analysis, aiding adaptive radiation therapy, transferring contours and dose distributions to radiation treatment planning systems, and archiving contours and dose distributions for patient follow-up and management.
- f) Secondary Monte Carlo dose calculation for patient specific quality assurance.
VERIQA must not be used while a patient is present. VERIQA must not be used for treatment planning.
Device Description
Software for viewing and analyzing of DICOM and DICOM RT data as well as for contouring of these data for radiation therapy. All the relevant data, including image data sets and treatment plans, can be imported into VERIQA. The software enables interactive viewing of these data in 2D/3D/4D and evaluation of the treatment plans with secondary Monte Carlo 3D dose calculation. The user can register images and process RT Dose, RT Plan, and RT Structure objects. Results can be saved in the DICOM RT format for use by other systems for radiation treatment planning purposes.
Ask a Question
Ask a specific question about this device
K Number
K191646Device Name
Beamscan MR
Date Cleared
2020-02-21
(246 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PTW-Freiburg Physikalisch-Technische-Werkstaetten
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BEAMSCAN MR system is used preferably in combined MRI-radiation therapy systems with static magnetic fields of up to 1.5T and is intended to collect beam data in water under the aspect of machine QA for the following purposes:
- acceptance testing and/or commissioning of a combined MRI-radiation therapy system
- measurements after repair or replacement of major treatment unit components of a combined MRI-Radiation therapy system
- beam data analysis according to international therapy dosimetry protocols
- acquisition, formatting and transfer of basic data to treatment planning systems
- periodic QA procedures, e.g. constancy check
- high precision data acquisition for scientific research (not a medical device indication)
Device Description
The BEAMSCAN MR system is comprised of a PMMA tank with a moving mechanism and radiation detectors. Further main components are a carriage with built-in electrometer, control unit and control interface. The carriage includes a water reservoir. The whole system is controlled by software for data display and processing.
Ask a Question
Ask a specific question about this device
K Number
K160405Device Name
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
Date Cleared
2017-10-20
(612 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OCTAVIUS System is intended to collect beam data for patient plan verification of a treatment planning system (TPS) and under the aspect of machine QA for the following purposes:
- IMRT patient plan verification
- periodic QA procedures, e.e. constancy checks
- beam data analysis according to international therapy dosimetry protocols
- measurements after repair or replacement of major treatment unit components
Device Description
The OCTAVIUS System is comprised of a two-dimensional ion chamber based detector array, uniformly arranged as a matrix and a separate detector interface for data acquisition. The detector array can be placed either in a static cubic or octagonal phantom or in a linear rotational phantom. For the measurement of moving radiation sources (e.g. the rotating gantry of a LINAC), the rotational phantom rotates synchronously with the gantry. An inclinometer, fixed to the gantry, delivers the gantry angle values which are used to align the rotating detector to the gantry. The whole system is controlled with software for data display and processing.
Ask a Question
Ask a specific question about this device
Page 1 of 1