(165 days)
Clarity Viewer is software that retrieves digital images and data from various sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
Images (including mammography) and data can be retrieved and displayed within the system and or across computer networks at distributed locations.
Clarity's archiving engine utilizes lossless algorithms for compression services (JLSL, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images received from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Clarity Viewer is software that retrieves digital images and data from various sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
Images (including mammography) and data can be retrieved and displayed within the system and or across computer networks at distributed locations.
Clarity's archiving engine utilizes lossless algorithms for compression services (JLSL, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images received from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
The provided document is an FDA 510(k) clearance letter for the iCRco Clarity Viewer, which is a Picture Archiving and Communications System (PACS). This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) submission's performance section.
The letter confirms substantial equivalence but does not provide the specifics of the studies conducted to demonstrate that equivalence. The information requested regarding acceptance criteria, sample sizes, expert qualifications, ground truth, and specific study designs (MRMC, standalone) is not present in this document.
The document only states the "Indications For Use" and general device function:
- Device Name: Clarity Viewer
- Indications For Use: Software that retrieves digital images and data from various sources (e.g., CT, MR, ultrasound, R/F, computed & direct radiographic devices, secondary capture, scanners, imaging gateways, or other imaging sources). Images (including mammography) and data can be retrieved and displayed within the system and/or across computer networks at distributed locations.
- Compression: Utilizes lossless algorithms for compression services (JLS, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
- Mammography Interpretation Requirement: Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
To answer the questions posed, the actual 510(k) submission document (K132499) would need to be consulted, specifically the sections detailing the performance studies and bench testing. This clearance letter is merely the FDA's decision based on that submission.
§ 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).