(41 days)
Qontrast software is a Windows 2000/Windows XP software application package. It is designed to view and quantify echographic image data.
Qontrast software is a Windows 2000/Windows XP software application package. It is designed to view and quantify echographic image data.
The provided 510(k) summary for the Qontrast software (K040399) does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.
The document is a standard 510(k) summary and FDA clearance letter, which typically focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It includes:
- Submitter information: Contact details of the company and contact person.
- Device identification: Trade name, common name, classification, and product code.
- Predicate device: Information about the device Qontrast software is being compared to.
- FDA clearance letter: Official communication from the FDA granting clearance to market the device.
- Indications for Use: A brief description of the intended purpose of the device.
Therefore, I cannot provide the requested information as it is not present in the given text.
To answer your request, a different type of document, such as a validation report, performance study, or a more detailed technical submission, would be required.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).