510(k) · Cleared
Recalled · Class II · 2014Efilm Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Efilm Medical, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 31, 2001 as substantially equivalent to K982862 (Applicare Medical Imaging, B.V., 1998) after a 15-day review. Its family tree reaches back 3 generations to 1990. 333 later devices descend from it. It has been recalled once.
- Decided
- Jul 31, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896095 (1990). 4 ancestors in all. 333 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 2 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 1 generation backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- This deviceK012211 Efilm WorkstationEfilm Medical, Inc. · 2001
- Descendant · cites it directly · 321 of its ownK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 133 of its ownK032401 OrthoviewOmsbar, Ltd. · 2003
- Descendant · 3 generations on · 129 of its ownK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- Descendant · 4 generations on · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · cites it directly · 80 of its ownK052411 Hipax Medical Imaging SoftwareSteinhart Medizinsysteme GmbH · 2005
Showing 5 of 333 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 333 · See all- K020995Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · cites it directly321descendants
- K032401OrthoviewOmsbar, Ltd. · 2003 · 2 generations on133descendants
- K042816Traumacad 1.2Orthocrat, Ltd. · 2004 · 3 generations on129descendants
- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · 4 generations on117descendants
- K052411Hipax Medical Imaging SoftwareSteinhart Medizinsysteme GmbH · 2005 · cites it directly80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −2 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −1 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| 0 (this device) | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | — |
| +1 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| +2 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| +3 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| +4 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +1 | K052411 | Hipax Medical Imaging Software | Steinhart Medizinsysteme GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 8 | 0 |
| 2010 | 5 | 0 |
| 2011 | 9 | 0 |
| 2012 | 3 | 0 |
| 2013 | 11 | 0 |
| 2014 | 13 | 0 |
| 2015 | 7 | 0 |
| 2016 | 13 | 0 |
| 2017 | 21 | 0 |
| 2018 | 11 | 0 |
| 2019 | 14 | 0 |
| 2020 | 20 | 0 |
| 2021 | 29 | 0 |
| 2022 | 20 | 0 |
| 2023 | 33 | 0 |
| 2024 | 24 | 0 |
| 2025 | 40 | 0 |
| 2026 | 27 | 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? (1)
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 |
|---|---|---|---|
| * | K982862 | Radworks Medical Imaging Software with Quality Control ModuleSummary page 1…g Communications System (PACS) 892.2050 (Class ) Image Processing System RadWorks™ Medical Imaging Software with Quality Control Module Applicare Medical Imaging B.V. K982862 08/13/1998 10/21/1998 Substantially Equivalent Radiology Radiology LLZ 892.2050 (Class Il eFilm™ Workstation is one of the… | 1998 |
What descends from it? (333)
See all 3338 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020995 | Efilm Workstation with Modules | 2002 | 321 |
| K052411 | Hipax Medical Imaging Software | 2005 | 80 |
| K023476 | Unipacs Workstation | 2003 | 12 |
| K071894 | Xebra Dicom Image Browser | 2007 | 2 |
| K141061 | Remoteye Viewer | 2014 | 1 |
| K092235 | Beyondimage Workstation | 2009 | 1 |
| K151687 | QuantorView | 2015 | 0 |
| K041326 | Medcommons Open Radiology Gateway | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2014 | Class II | Z-0068-2015 | Device Design | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K020995 (Efilm Medical, Inc., 2002) has gone furthest, with 321 descendants of its own.
- 6 other devices also cite its predicate K982862.
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?
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at…
Read the full statement (144 words)
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012211: Efilm Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012211
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026