(26 days)
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
The FCRView is an image viewer workstation that offers a fully integrated solution for managing the CR modality, as well as built-in viewing, archiving and distribution capabilities. It can import and display ultrasonic images and generalpurpose images from digital cameras, and other general purpose images (such as jpeg images) on screen and/or print via a typical paper printer. Images captured on the FCR reader unit are displayed on the FCRView along with typical tools to aid in reading the images. The FCRView also incorporates a builtin archiving and CDR/DVDR image output system.
A summary description of the key features of the system follows:
- FCRView (CR VW 674) is a modality and Image Viewing workstation . intended to associate FCR images (except mammography images) with patient and exam information, and apply image processing to facilitate diagnosis.
- . Currently interfaces with Fuji CR and also accepts images from other modalities such as Ultrasound as well as general purpose (jpg) images.
- . FCRView incorporates a built-in archiving and CDR/DVDR image output svstem
The provided document is a 510(k) summary for a medical device called FUJIFILM FCRView. It states that the device is a modification to an already cleared product (FUJIFILM CR Console K041990) and the FCR AXON (Class I Exempt). The submission focuses on demonstrating substantial equivalence to these predicate devices rather than proving performance against specific acceptance criteria through a new clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not present:
- A table of acceptance criteria and the reported device performance: This document asserts substantial equivalence, meaning it claims the modified device performs similarly to the predicate devices, rather than outlining new performance metrics and results.
- Sample size used for the test set and the data provenance: No new test set or provenance information is provided for a new study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: No such study is mentioned or referenced.
- Standalone performance study information: No standalone study performance is detailed.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as this is not a de novo submission describing algorithm training.
- How the ground truth for the training set was established: Not applicable.
The "SUMMARY OF STUDIES" section states: "The FCRView has been evaluated for electrical, mechanical and radiation safety and conforms with applicable medical device safety standards." This refers to safety testing, not a clinical performance study against specific acceptance criteria for image interpretation or diagnostic accuracy.
The document relies solely on establishing substantial equivalence to previously cleared devices based on similar technology, materials, safety, effectiveness features, and design.
§ 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).