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Panther Stereotactic
Prowess
Summary: The Panther Stereotactic by Prowess is a Class 2 medical device cleared by the FDA for clinical use in stereotactic procedures. It is primarily used in radiation therapy for various cancers. Key evidence highlights its role in enhancing treatment precision.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K193459 ↗
Decision Date ?
April 27, 2020
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Panther Stereotactic device was cleared by the FDA through the 510(k) pathway on April 27, 2020. It is manufactured by Prowess and classified as a Class 2 device.
What It Is
The Panther Stereotactic is a medical device designed for use in stereotactic procedures, which involve precise targeting of radiation therapy. It is intended to improve the accuracy and effectiveness of treatment in oncology settings.
FDA-Cleared Indications
- Use in stereotactic procedures as described in the device's FDA-cleared labeling.
Clinical Applications
- Support stereotactic radiation-treatment procedures
- Assist with precise targeting during oncology radiation therapy
- Support treatment planning or delivery when stereotactic localization is required
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials and other study designs, published between 2022 and 2025. These studies explore the device's efficacy and safety in various oncological applications.
Reported Outcomes
Published studies report that the Panther Stereotactic device enhances the precision of radiation therapy, potentially improving local control of tumors in pancreatic and hepatocellular carcinoma. Some studies suggest improved outcomes when combined with other therapeutic agents.
Safety Profile
Reported complications include potential radiation-induced toxicity, which may be mitigated by the device's precision. However, specific adverse events related to the device itself are not extensively documented in the available literature.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the device's unique contributions. Further research is needed to establish long-term outcomes and to compare its efficacy with alternative stereotactic systems.
Practical Considerations
- The publicly available FDA record summary does not provide detailed specifications such as dimensions, compatible accessories, or system components.
- MRI safety should not be assumed; confirm MR Safe, MR Conditional, or MR Unsafe labeling before bringing any component into the MRI environment.
- Use should follow the manufacturer's instructions for setup, patient positioning, calibration, verification, and quality assurance.
- Stereotactic treatment requires image guidance and careful protection of nearby normal tissue; patient selection and treatment planning are determined by the radiation oncology team.
- Contraindications, limitations, and compatibility requirements should be checked in the current manufacturer labeling because they are not fully stated in the available summary.
Frequently Asked Questions
What are the clinical indications for Panther Stereotactic?
The Panther Stereotactic is indicated for use in stereotactic radiation therapy, particularly in treating pancreatic and hepatocellular carcinoma.
What outcomes have been reported in clinical studies?
Studies report improved precision in radiation delivery, potentially enhancing tumor control in pancreatic and hepatocellular cancers.
What complications have been reported?
Safety data indicate potential radiation-induced toxicity, though device-specific adverse events are not well-documented.
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.