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510(k) Data Aggregation
K Number
K143514Device Name
Panther StereoSeed
Manufacturer
Date Cleared
2015-12-11
(365 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PROWESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Panther StereoSeed module is intended to create a plan that is optimized for seed locations and needle directions, allowing needles to be inserted in any angle in order to avoid critical structures.
Device Description
Panther StereoSeed is an optional software module that has been added to the existing Prowess Panther Brachy system to produce a seed implant plan that is optimized for seed locations and needle directions. The key distinction between Panther StereoSeed and traditional brachytherapy systems is that StereoSeed allows plans to be created such that bones and critical structures can be avoided.
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K Number
K122616Device Name
PANTHER OIS/R & V MODEL VERSION 2.0
Manufacturer
Date Cleared
2012-12-21
(116 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PROWESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Panther QIS|R&V is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allows the user to:
- . Enter or import, modify, store and archive treatment plans and images from treatment planning systems.
- Import, view, manipulate, enhance, annotate, store, and archive radiological . images.
- Select and provide radiation treatment plans to a radiation treatment delivery . system for patient treatment.
- Store and view treatment records provided by the radiation treatment delivery . system.
- Monitor and track treatment progress. +
- When Panther OIS|R&V is acting as an R&V system, verify the delivery device's . settings against the planned parameters, record the treatment parameters settings and prevent treatment if the parameters are out of tolerance.
Device Description
Panther OIS|R&V is medical device software which allows the user to deliver radiation treatment on linear accelerator to a patient. The software has been developed to be a record and verify system that also manages oncology medical information in order to simplify the oncologist administrative tasks and to optimize the quality of patient treatment. It is a Windows® based system, which uses a single database that can be accessed by any Panther OIS|R&V client station in the treatment facility. Additionally, Panther OIS|R&V is capable of performing such functions as:
- lmporting treatment plans in DICOM or RTP format -
- Downloading of beams contained in the treatment plans to the linear accelerator ﺖ
- Verifying that the beams from the treatment plan are correctly set up on the linear accelerator
- Recording treatments delivered by the linear accelerator -
- Managing patient schedules ・
- Managing schedules for resources such as treatment machines and personnel "
- Maintaining a central repository of treatment plans and records -
- Documenting, monitoring and updating treatments and treatment plan information -
- Performing administrative tasks such as patient management. -
- Data locking or warning to prevent simultaneous access to patient (Tx) data -
- -Reports of patients and treatment history
- Manual Recording of treatment beams ﺖ
- Late Resumption of incomplete treatments -
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K Number
K101076Device Name
PROWESS PANTHER PROARC, MODEL VERSION 5.0
Manufacturer
Date Cleared
2010-07-27
(99 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PROWESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Prowess Panther ProArc module is intended to support radiation treatment planning by creating treatment plans for intensity-modulated arc radiation therapy.
Device Description
Panther ProArc is an optional software module to the Prowess Panther radiation therapy treatment planning system. It is an extension to the inverse planning, IMRT planning capability provided by Prowess Panther (previously cleared under K032456). Panther ProArc includes tools for visualizing and creating arc therapy plans, defining arc therapy beam properties and constraints, and allowing the user to do export these plans for delivery via DICOM protocol to the linear accelerator for treatment.
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K Number
K100801Device Name
PUMA MODEL VERSION 1.0
Manufacturer
Date Cleared
2010-06-18
(88 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PROWESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Puma is to allow the radiation therapist to deliver treatment to the patient via linear accelerator (linac). This entails selection of the patient, selection of the day's correct treatment for the patient, set up, and delivery of the treatment fields and recording of the treatment. Puma supports auto-sequencing, a process of automatically downloading a group of fields or segments from the record and verify system to the control of the linear accelerator sequentially, without user intervention. In addition, Puma also supports IMRT (Intensity Modulated Radiation Therapy), a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.
Device Description
Puma is a medical device, which allows the user to deliver radiation treatment on linear accelerator to a patient. The software has been developed to be a record and verify system that also manages oncology medical information in order to simplify the oncologist administrative tasks and to optimize the quality of patient treatment. It is a Windows® based system, which uses a single database that can be accessed by any Puma client station in the treatment facility. Additionally, Puma is capable of performing such functions as:
- Importing treatment plans in DICOM or RTP format -
- Downloading of beams contained in the treatment plans to the linear accelerator -
- Verifying that the beams from the treatment plan are correctly set up on the linear accelerator -
- Recording treatments delivered by the linear accelerator ・
- Managing patient schedules -
- Managing schedules for resources such as treatment machines and personnel -
- Maintaining a central repository of treatment plans and records -
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K Number
K083502Device Name
PANTHER REALART, MODEL 4.7
Manufacturer
Date Cleared
2009-05-05
(161 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PROWESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Panther™ RealART is used to correct geometric mismatches between radiation beams and the treatment target under on-line image-guidance. The optional software module is part of the family of treatment planning products under the trade name Panther™.
Device Description
PANTHER™ RealART is an optional software module to the Prowess radiation therapy planning software for supporting online image-guided radiation therapy. The Panther™ RealART on-line plan adaptation system is composed of a workstation with two Intel Quad-Core Xeon processors (or later versions) running Windows XP operation system (or later versions) and proprietary software that allows the trained users to adjust radiation therapy treatment plans based on the images acquired on the day of treatment with the patient at the treatment position.
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K Number
K032456Device Name
PROWESS
Manufacturer
Date Cleared
2003-10-16
(66 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PROWESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prowess 3D™ Radiation Therapy Treatment Planning System, including the IMRT option Panther™, is used to plan photon and electron radiation therapy treatments using linear accelerators and Cobalt-60 beams. The optional software module with the trade name Pather™ provides treatment planning for intensity-modulated radiation therapy (IMRT) treatments using external photon beams.
Device Description
PROWESS PANTHER is an inverse planning option to the Prowess radiation therapy planning software for supporting intensity-modulated radiation therapy (IMRT) (K980379). The Prowess 3D system is composed of a Workstation with an Intel Pentium* processors (or later versions) running Windows 2000 operation system (or later versions) and proprietary software that allows the trained users to generate radiation therapy treatment plans.
The Prowess IMRT software contains 3 components:
- 1) Objective and constraint specification --- The first step of the inverse planning process is to allow the user to specify the treatment objectives, which include the dose and dose uniformity to the target or targets, the dose and volume limits to different critical organs, and the relative importance of achieving these objectives.
- 2) Optimization --- This is a process by which the system iteratively adjust the deliverable parameters including the field shapes and their weights to derive a treatment plan that best achieves the treatment objectives. A proven and most widely used optimization algorithm, simulated annealing, was used. As with P3IMRT™ system by ADAC (K002237), IMRT uses the convolution superposition algorithm as the final dose calculation engine.
- 3) DICOM Transfer --- This involves transfer the plan parameters via DICOM-RT to a delivery control system (a Record and Verify system or the linear accelerator controller itself) for delivery.
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