# K082144: Amicas Pacs, Version 6.0 - Pathway: 510(k) (Traditional) - Applicant: Amicas, Inc. - Decided: Sep 5, 2008 after 37 days - Product code: LLZ (System, Image Processing, Radiological) - Device class: 2 - Regulation: 21 CFR 892.2050 - Recalls of this device: 13 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 6 generations back to K954678 (1996). 6 ancestors in all. 3 later devices descend from it; 2 cite it directly. 0 of 10 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K073526: Amicas Vision Series Pacs, Model 5.5, Amicas, Inc. (2008) Summary page 1. ## Most influential descendants - K173475: Merge PACS (2017), 1 descendant of its own - K192455: Merge PACS (2019), 0 descendants of its own - K124048: Imageqube (2013), 0 descendants of its own ## Recalls of this device - May 24, 2017 · Class II · Z-2601-2017: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. - May 8, 2017 · Class II · Z-2590-2017: Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing. - May 8, 2017 · Class II · Z-2591-2017: When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis. - Apr 4, 2016 · Class II · Z-1431-2017: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. - Apr 4, 2016 · Class II · Z-1176-2017: Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. - Mar 28, 2016 · Class II · Z-0599-2017: The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing. - Mar 28, 2016 · Class II · Z-0726-2017: Cut lines on the image may present horizontally rather than vertically. - Feb 5, 2016 · Class II · Z-2363-2016: When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same. - Jan 30, 2016 · Class II · Z-2301-2016: Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. - Jan 30, 2016 · Class II · Z-2303-2016: A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations. - Jan 30, 2016 · Class II · Z-2379-2016: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. - Jan 30, 2016 · Class II · Z-2531-2016: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) - Jan 30, 2016 · Class II · Z-2532-2016: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) ## Indications for use AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist. AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging. AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images. Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems. AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application. Source page: https://510kreport.com/device/K082144 Methodology: https://510kreport.com/methodology