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510(k) Data Aggregation
K Number
K001833Device Name
PREFERENCE TREATMENT SYSTEMManufacturer
Date Cleared
2000-09-28
(104 days)
Product Code
Regulation Number
892.5050Type
SpecialPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
PREFERENCE TREATMENT SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K983793Device Name
PREFERENCE TREATMENT SYSTEMManufacturer
Date Cleared
1999-10-05
(343 days)
Product Code
Regulation Number
892.1000Type
TraditionalPanel
RadiologyReference & Predicate Devices
Why did this record match?
Device Name :
PREFERENCE TREATMENT SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
- The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
- The indications for use of pReference Treatment System are expanded to include lesions requiring extracranial stereotactic radiotherapy or radiosurgery. These include hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
- The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Device Description
Not Found
AI/ML Overview
The provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. This document is an FDA 510(k) clearance letter for the "pReference Treatment System," which is a treatment planning system. It outlines the device's indications for use and confirms its substantial equivalence to a predicate device.
Therefore, I cannot populate the requested information. The document focuses on regulatory clearance rather than a detailed performance study.
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