510(k) · Cleared
ClearedRadworks Medical Imaging Software with Quality Control Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applicare Medical Imaging, B.V. · LLZ System, Image Processing, Radiological
Cleared on Oct 21, 1998 as substantially equivalent to K962699 (Applicare Medical Imaging, B.V., 1996) after a 69-day review. Its family tree reaches back 2 generations to 1990. 463 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896095 (1990). 3 ancestors in all. 463 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 1 generation backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- This deviceK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- Descendant · cites it directly · 333 of its ownK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 321 of its ownK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 133 of its ownK032401 OrthoviewOmsbar, Ltd. · 2003
- Descendant · 4 generations on · 129 of its ownK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- Descendant · 5 generations on · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
Showing 5 of 463 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 463 · See all- K012211Efilm WorkstationEfilm Medical, Inc. · 2001 · cites it directly333descendants
- K020995Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · 2 generations on321descendants
- K032401OrthoviewOmsbar, Ltd. · 2003 · 3 generations on133descendants
- K042816Traumacad 1.2Orthocrat, Ltd. · 2004 · 4 generations on129descendants
- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · 5 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −1 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| 0 (this device) | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| +1 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| +2 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| +3 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| +4 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| +5 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 11 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 13 | 0 |
| 2010 | 7 | 0 |
| 2011 | 14 | 0 |
| 2012 | 11 | 0 |
| 2013 | 19 | 0 |
| 2014 | 21 | 0 |
| 2015 | 15 | 0 |
| 2016 | 15 | 0 |
| 2017 | 31 | 0 |
| 2018 | 20 | 0 |
| 2019 | 19 | 0 |
| 2020 | 25 | 0 |
| 2021 | 32 | 0 |
| 2022 | 26 | 0 |
| 2023 | 43 | 0 |
| 2024 | 28 | 0 |
| 2025 | 45 | 0 |
| 2026 | 34 | 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 |
|---|---|---|---|
| * | K962699 | Radworks Medical Imaging SoftwareSummary page 1…DEVICES The RadWorks Medical Imaging Software with Quality Control Module is substantially equivalent to the original version of the RadWorks Medical Imaging Software (K962699). B. DEVICE DESCRIPTION The RadWorks Quality Control Module is intended to be used by authorized staff to perform various qualit… | 1996 |
What descends from it? (463)
See all 4637 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012211 | Efilm Workstation | 2001 | 333 |
| K012093 | Aetmed Image Processing Software | 2001 | 64 |
| K012779 | Iconnection 3D | 2001 | 31 |
| K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy… | 2004 | 22 |
| K993761 | Cardiovascular Measurement System - View | 1999 | 6 |
| K083618 | Pacs Scan | 2009 | 1 |
| K030363 | Org@Nizer, Model Version 3.0 | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K012211 (Efilm Medical, Inc., 2001) has gone furthest, with 333 descendants of its own.
- 8 other devices also cite its predicate K962699.
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 RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.
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/K982862 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982862: Radworks Medical Imaging Software with Quality Control Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982862
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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