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Acqplan
Philips Medical Systems (Cleveland)
Summary: Acqplan is a device used in radiotherapy treatment planning, particularly for prostate cancer. Key evidence includes dosimetric evaluations using MRI-based planning.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K974770 ↗
Decision Date ?
September 2, 1998
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
Acqplan was cleared by the FDA via the 510(k) pathway on September 2, 1998. It is manufactured by Philips Medical Systems and classified as a Class 2 device.
What It Is
Acqplan is a treatment planning system used in radiotherapy, designed to assist in the precise delivery of radiation doses. It is primarily used in planning for prostate cancer treatments.
FDA-Cleared Indications
- Treatment planning for external-beam radiotherapy.
- Calculation and evaluation of radiation dose distributions for radiotherapy treatment plans.
- Use in planning radiation treatments for patients with cancer, including prostate cancer when clinically appropriate.
Clinical Applications
- Creating radiotherapy treatment plans.
- Calculating radiation dose distribution within the target and surrounding tissues.
- Reviewing treatment geometry and dose plans before radiation delivery.
- Supporting radiotherapy planning for prostate cancer.
Evidence Summary
The available literature includes two studies, one from 2005 and another from 2008, focusing on dosimetric evaluations and dose-response relationships in radiotherapy.
Reported Outcomes
Published studies report that Acqplan provides accurate dosimetric evaluations for MRI-based treatment planning in prostate cancer. The system facilitates precise dose distribution, which is crucial for effective treatment outcomes.
Safety Profile
Reported complications include no specific adverse events or complications directly linked to the use of Acqplan in the provided studies. Further research may be needed to fully assess safety.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of comprehensive safety data. Further research is needed to explore long-term outcomes and potential complications.
Practical Considerations
- Acqplan is treatment-planning software, not a radiation-delivery device or an implantable device.
- The accuracy of a plan depends on the quality of the patient images, tissue and anatomy information, dose-calculation methods, and clinician verification.
- MRI-based planning may require appropriate image registration, geometric-distortion assessment, and validation within the clinical workflow.
- The system must be compatible with the treatment machine, imaging systems, data formats, and quality-assurance procedures used by the radiation oncology department.
- It does not have a physical device size, vessel compatibility, or implant duration; software version, workstation, and site-specific support requirements should be confirmed with the manufacturer.
Frequently Asked Questions
What are the clinical indications for acqplan?
Acqplan is indicated for use in radiotherapy treatment planning, particularly for prostate cancer.
What outcomes have been reported in clinical studies?
Studies have reported accurate dosimetric evaluations and effective dose distribution in prostate cancer treatment planning.
What complications have been reported?
No specific complications have been reported in the provided studies, but further research is needed to assess safety comprehensively.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.