510(k) · Cleared
Recalled · Class II · 2016Evms (Enterprise Visual Medical System Software)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emageon, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 7, 2005 as substantially equivalent to K012097 (Ultravisual Medical Systems, 2001) and 1 other predicate after a 12-day review. Its family tree reaches back 5 generations to 1996. It has been recalled 9 times.
- Decided
- Dec 7, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954678 (1996). 8 ancestors in all, the oldest K924178 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK012097 VortexUltravisual Medical Systems · 2001
- 1 generation backK042008 UltravisualEmageon Uv, Inc. · 2004
- This deviceK053281 Evms (Enterprise Visual Medical System Software)Emageon, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| −1 | K042008 | Ultravisual | Emageon Uv, Inc. | 2004 | — |
| 0 (this device) | K053281 | Evms (Enterprise Visual Medical System Software) | Emageon, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012097 | VortexSummary page 2…Archiving and Communication System Proprietary Name: EVMSTM (formerly UltravisualTM) Cleared Device(s): Vortex TM , 510(k): K012097, UltravisualTM, 5 10(k) K042008 1.5 Device Description and Intended Use Emageon Inc.'s EVMSTM software is integrat… | 2001 |
| * | K042008 | UltravisualSummary page 2…Proprietary Name: EVMSTM (formerly UltravisualTM) Cleared Device(s): Vortex TM , 510(k): K012097, UltravisualTM, 5 10(k) K042008 1.5 Device Description and Intended Use Emageon Inc.'s EVMSTM software is integrated client-server software package… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2016 | Class II | Z-0614-2017 | Software design | 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 to radiation (x-ray). |
| Apr 4, 2016 | Class II | Z-1470-2017 | Software design | 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 | Software design | 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 the first viewport. |
| Jan 30, 2016 | Class II | Z-2685-2016 | Software design | 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 | Software design | Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite. |
| Nov 17, 2015 | Class II | Z-1180-2017 | Software design | 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 | Software design | 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 studies for another patient. |
| May 6, 2013 | Class II | Z-2796-2016 | Software design | 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 | Device Design | 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 incorrect interpretation of tissue… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K012097.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (195 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053281 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053281: Evms (Enterprise Visual Medical System Software).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053281
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026