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The FACTS is intended to produce routine cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles of the entire human body. In addition, this device's fluoroscopic mode is intended to be used in CT interventional procedures and allows some minimally invasive surgical procedures to be implemented with the CT system. Procedures possible with this equipment include tumor biopsies, abscess drainages, bone intervention, visceral, neck trauma evaluation and catheter placement for organ assessment.

The FACTS X-Ray System, is a device intended to produce cross-sectional images of the human body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The solid state x-ray imager is a device intended to be used to visualize anatomical structures by using a flat panel to convert x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

The provided text is a 510(k) summary for the Picker FACTS (Fluoroscopic Assisted Computed Tomography System) and does not contain information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets acceptance criteria. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed studies.

Therefore, I cannot extract the requested information from the given text. The document primarily describes:

• Device Name: FACTS (Fluoroscopic Assisted Computed Tomography System)
• Classification Name: Computed Tomography X-Ray System and Solid State X-Ray Imaging Device
• Intended Use: To produce cross-sectional images of the human body by computer reconstruction of x-ray transmission data. Also, its fluoroscopic mode is intended for CT interventional procedures, including tumor biopsies, abscess drainages, bone intervention, visceral/neck trauma evaluation, and catheter placement for organ assessment.
• Predicate Devices: PQ2000+ CT System (K955268), C-Arm with DynaRad Diagnostic Source Assembly (K981267), and SSXI equivalent to the image intensifier of the Orbitor (K800639).
• Technological Characteristics: Claims substantial equivalence in features, specifications, materials, and mode of operation to predicate devices, stating no new questions of safety or effectiveness are raised.
• Regulatory Status: Granted marketing permission in K982010.

To answer your questions, I would need a different type of document, such as a clinical study report, a detailed design verification and validation report, or performance testing protocols and results.

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General Purpose Fluoroscope Applications

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The provided text describes a 510(k) clearance letter from the FDA for a device called "Facts Monoblock Diagnostic X-Ray Tube Housing Assembly." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, etc.), or specific comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the given text. The document is solely a regulatory clearance letter acknowledging substantial equivalence based on prior submissions, not a scientific study report.

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