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To process (develop) medical imaging films for viewing by physicians. This may be used in the imaging modalities of Ultrasound, X-Ray, Nuclear Medicine, Computed Tomography, Mammography, Cardiology, and Magnetic Resonance.

All currently marketed automatic film processors have the same basic components, including a feed and detection mechanism, a processing system consisting of chemical tanks and transport racks, a washer, a dryer, a receiving bin, and controls and indicators. Major subsystems include water supply, temperature regulation, chemical replenishment, and solution circulation.

The device performs standard photographic processing of previously exposed sheets or rolls of silver-halide based films. The processed films contain acquired anatomical images for viewing by physicians, typically of the radiological discipline specialty. The photographic processing (developing) technique employed by these automatic processors is the same as all devices manufactured by several companies, and has gone basically unchanged in approximately fifteen years. The film medium is mechanically transported for immersion in two chemical baths (developer and fixer), is rinsed in water, dried, and then ejected for viewing and archival purposes.

The Agfa family of automatic film processors also offers additional features such as daylight handling and processing, laser film recorder docking, and automatic film handling for various types and sizes of imaging films used in the above radiographic applications. Some models offer the E.O.S. (Environmentally Optimized System) feature. This feature employs an additional fixer tank technique that reduces fixer solution consumption and waste.

This document, K981280, is a 510(k) summary for Agfa's Automatic Film Processors. It states the intended use of the device and describes its basic components and function. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. This document serves as a regulatory submission confirming substantial equivalence to existing devices, not a performance study report.

Therefore, I cannot provide the requested information from the given text.

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To provide diagnostic quality images for aid in physician diagnosis. This is used in the X-Ray imaging modality, mainly in Chest, Skeleton, and Gastro-Intestinal imaging applications.

The ADC COMPACT is a Computed Radiography Imaging System. This system replaces conventional X-Ray cassettes that contain one or two intensifying screens and photographic light sensitive film. Computed radiography utilizes filmless cassettes. Instead of screens and photographic film to obtain the diagnostic image, the system employs what is termed as an imaging plate. This plate is coated with photo stimulatable storage phosphors that are sensitive to the X-Ray energy, and capable of retaining a latent image. This imaging plate is inserted into a device that scans it and releases the latent image in the form of light which is converted into a digital bit stream. This bit stream of image data is stored, and introduced to the PACS (Picture Archiving and Computerized System) network in DICOM format.

The major difference between the ADC COMPACT and the previous model in commercial distribution is the actual physical size of the portion of the system that reads and digitizes the imaging plates.

The provided text describes a Computed Radiography Imaging System called the ADC COMPACT. However, it does not contain specific information about detailed acceptance criteria, device performance metrics, or study designs (like sample sizes, expert qualifications, or ground truth establishment) that would typically be found in a clinical study report.

The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed metrics.

Therefore, I cannot provide the requested table and study details. The text only mentions:

• Acceptance Criteria/Performance (General):
  • The device "replaces conventional X-Ray cassettes" and uses "filmless cassettes" with "imaging plates."
  • It is "capable of retaining a latent image."
  • It converts the latent image into a "digital bit stream" for PACS in DICOM format.
  • It provides "diagnostic quality images for aid in physician diagnosis."
  • The software has been "evaluated and verified with respect to level of concern utilizing the methods suggested by the Office of Device Evaluation (ODE)." The software risk falls into the "Broadly Acceptable, or Lower Level of Concern range."
  • AGFA has "conducted adequate safety and effectiveness testing in clinical environments that would be relevant to an assessment of substantial equivalence." (No details provided)

The document explicitly states that the "major difference between the ADC COMPACT and the previous model...is the actual physical size of the portion of the system that reads and digitizes the imaging plates." This implies that the core image quality and diagnostic capabilities are assumed to be similar to the predicate device (ADC 70, K904519A).

Without a detailed performance study in the provided text, the specific information for your questions 1 through 9 cannot be extracted.

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The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.

The LR 5200 is a laser based (Helium-neon) film recorder, designed for producing high quality gray scale diagnostic medical images, when interfaced to a host imaging device. Typical host imaging devices would include those of Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities.

There is insufficient information in the provided text to describe acceptance criteria and associated study details. The document is a 510(k) summary for a "Laser Film Recorder" and focuses on device description, technological characteristics, and substantial equivalence to other devices. It does not contain any details about acceptance criteria for performance metrics, clinical studies, or AI/algorithm performance.

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