510(k) · Cleared
Recalled · Class II · 2016Efilm Workstation with Modules
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 Apr 12, 2002 as substantially equivalent to K012211 (Efilm Medical, Inc., 2001) after a 15-day review. Its family tree reaches back 4 generations to 1990. 321 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 12, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896095 (1990). 5 ancestors in all. 321 later devices descend from it, 15 citing it directly.
- Root · 4 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 3 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 2 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 1 generation backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- This deviceK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002
- Descendant · cites it directly · 133 of its ownK032401 OrthoviewOmsbar, Ltd. · 2003
- Descendant · 2 generations on · 129 of its ownK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- Descendant · 3 generations on · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · cites it directly · 78 of its ownK070618 Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007
- Descendant · cites it directly · 75 of its ownK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
Showing 5 of 321 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 321 · See all- K032401OrthoviewOmsbar, Ltd. · 2003 · cites it directly133descendants
- K042816Traumacad 1.2Orthocrat, Ltd. · 2004 · 2 generations on129descendants
- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · 3 generations on117descendants
- K070618Dicompacs, Model 5Oehm Und Rehbein GmbH · 2007 · cites it directly78descendants
- K063539Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007 · cites it directly75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −3 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −2 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −1 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| 0 (this device) | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | — |
| +1 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| +2 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| +3 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +1 | K070618 | Dicompacs, Model 5 | Oehm Und Rehbein GmbH | 2007 | — |
| +1 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 9 | 0 |
| 2012 | 3 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 6 | 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 | 39 | 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 |
|---|---|---|---|
| * | K012211 | Efilm WorkstationSummary page 1…4 9442 eFilm Workstation with Modules Picture Archiving Communications System (PACS) 892.2050 Class i Image Processing System eFilm™ Workstation™ eFilm Medical Inc. K012211 07/16/2001 07/31/2001 Substantially Equivalent Radiology Radiology LLZ 892.2050 Class | USFDA 510(k) Premarket Notification… | 2001 |
What descends from it? (321)
See all 32115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032401 | Orthoview | 2003 | 133 |
| K070618 | Dicompacs, Model 5 | 2007 | 78 |
| K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | 2007 | 75 |
| K043350 | Mistar, Model V3.2 | 2004 | 12 |
| K081304 | Alz Web Pacs, Version 1.0 | 2008 | 8 |
| K102000 | Imagys | 2010 | 3 |
| K041162 | Ortho-CMS | 2004 | 2 |
| K140797 | Ipacs Medical Image Management System | 2014 | 0 |
| K103679 | Axis Pacs, HMS Pacs | 2011 | 0 |
| K082135 | Showcase | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2016 | Class II | Z-0707-2017 | Software design | A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed on the projection images after calibration is performed… |
| 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 12 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K032401 (Omsbar, Ltd., 2003) has gone furthest, with 133 descendants of its own.
- 7 other devices also cite its predicate K012211.
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 with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules 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). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have…
Read the full statement (136 words)
eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules 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). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution’s existing HIS or RIS for a fully integrated electronic patient record.
Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
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/K020995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020995: Efilm Workstation with Modules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020995
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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