Search Results

.decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filters for missing tissue and intensity modulation for external beam radiation therapy.

.decimal tissue compensator / intensity modulator manufacturing service

The provided text does not contain information about specific acceptance criteria and a study demonstrating the device meets those criteria. The document is a 510(k) summary for a "Pre-market Notification" for a medical device called ".decimal tissue compensator / intensity modulator manufacturing service".

Here's a breakdown of what the document does include:

• Premarket Notification (K040804): This is a 510(k) summary, aiming to demonstrate substantial equivalence to previously marketed devices.
• Device Name: .decimal tissue compensator / intensity modulator manufacturing service.
• Intended Use: Manufactures solid filters for missing tissue and intensity modulation for external beam radiation therapy.
• Technological Characteristics: References internal company documents (Device Master Record, Processing Work Order, MSDS sheets) but does not provide details on these characteristics or performance metrics.
• Predicate Devices: A list of previously cleared devices to which this device claims substantial equivalence.
• FDA Clearance Letter: A letter from the FDA stating that the device has been reviewed and determined to be substantially equivalent. This is a regulatory clearance, not a performance study report.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because this information is not present in the provided text.

To answer your request, I would need a document that specifically details:

• Performance metrics (e.g., accuracy, precision, fabrication tolerances).
• Quantitative acceptance criteria for those metrics.
• A written report of a study (validation, verification, clinical trial) that tested the device against these criteria.

Ask a specific question about this device

This device is intended for mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.

Blocking Trays are to be used as an accessory to a Linac. Custom blocks are mounted onto Blocking trays and slid into the Linac into their accessory holder thereby stenciling the radiation beam onto the patient. Compensators are also mounted on blocking trays and slid into the Linac changing the radiation beam fluence unique to a patient's anatomy.

This 510(k) submission does not contain information on acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a "Blocking Tray" accessory to a Linac, and the FDA's response indicating substantial equivalence to predicate devices.

The document primarily focuses on:

• Device Name: Blocking Tray
• Intended Use: For mounting blocks and/or compensators/modulators for insertion into a Linear Accelerator head.
• Technological Characteristics: References internal documents (DMR-02 Device Master Record, PD-02 Processing a Blocking Tray Work Order, Acrylic MSDS, Polycarbonate MSDS) which are not provided.
• Predicate Devices: A list of previously cleared accessory devices from various manufacturers.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, or study details because it is not present in the provided text.

This type of 510(k) summary typically establishes substantial equivalence by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and does not raise different questions of safety and effectiveness. It does not generally include detailed performance studies with acceptance criteria in the public summary document itself, especially for such a relatively simple accessory device.

Ask a specific question about this device