# K053281: Evms (Enterprise Visual Medical System Software)

- Pathway: 510(k) (Traditional)
- Applicant: Emageon, Inc.
- Decided: Dec 7, 2005 after 12 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954678 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012097: Vortex, Ultravisual Medical Systems (2001) Summary page 2.
- K042008: Ultravisual, Emageon Uv, Inc. (2004) Summary page 2.

## Recalls of this device
- Jul 14, 2016 · Class II · Z-0614-2017: It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient
- Apr 4, 2016 · Class II · Z-1470-2017: The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
- Jan 31, 2016 · Class II · Z-2627-2016: Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than t
- Jan 30, 2016 · Class II · Z-2685-2016: Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
- Dec 17, 2015 · Class II · Z-0794-2016: Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
- Nov 17, 2015 · Class II · Z-1180-2017: The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
- Apr 9, 2015 · Class II · Z-2715-2016: When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or st
- May 6, 2013 · Class II · Z-2796-2016: Multiple studies were missing at a customer location that never made it to the archive before watermarking
- Jan 1, 2008 · Not classified · Z-1644-2008: Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to 

## Indications for use
The Enterprise Visual Medical System(TM) is classified as a picture archive and communications system. It is a software only solution developed by Emageon Inc., combined with other 3rd party off the shelf software, standard computer workstations and standard storage devices that allow authorized physicians and authorized healthcare professionals to manage, access, visualize and store digital medical images, and data associated with the images, across the enterprise using advanced visualization tools, clinical content management and clinical workflow through a graphical user interface. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of third-party electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data.

Source page: https://510kreport.com/device/K053281
Methodology: https://510kreport.com/methodology