510(k) · Cleared
ClearedRadworks Medical Imaging Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applicare Medical Imaging, B.V. · LMD System, Digital Image Communications, Radiological
Cleared on Aug 19, 1996 as substantially equivalent to K911752 (Icon Medical Systems, Inc., 1991) and 1 other predicate after a 39-day review. Its family tree reaches back 1 generation to 1990. 1 of the 851 devices in its family, counting itself, has a Class I recall. 848 later devices descend from it.
- Decided
- Aug 19, 1996
- Review
- 39 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K896095 (1990). 2 ancestors in all. 848 later devices descend from it, 9 citing it directly. 1 of the 851 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- This deviceK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- Descendant · cites it directly · 463 of its ownK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- Descendant · cites it directly · 354 of its ownK981535 Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 2 generations on · 333 of its ownK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
Showing 5 of 848 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 848 · See all- K982862Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998 · cites it directly463descendants
- K981535Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999 · cites it directly354descendants
- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · 2 generations on353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
- K012211Efilm WorkstationEfilm Medical, Inc. · 2001 · 2 generations on333descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| 0 (this device) | 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 | — |
| +1 | K981535 | Focus Pilot Contouring Workstation | Computerized Medical Systems, Inc. | 1999 | — |
| +2 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +2 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
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 |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 13 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 12 | 0 |
| 2008 | 16 | 0 |
| 2009 | 14 | 0 |
| 2010 | 14 | 0 |
| 2011 | 24 | 0 |
| 2012 | 20 | 0 |
| 2013 | 29 | 0 |
| 2014 | 34 | 0 |
| 2015 | 30 | 0 |
| 2016 | 28 | 0 |
| 2017 | 47 | 0 |
| 2018 | 44 | 0 |
| 2019 | 42 | 0 |
| 2020 | 53 | 0 |
| 2021 | 58 | 0 |
| 2022 | 55 | 0 |
| 2023 | 72 | 0 |
| 2024 | 55 | 0 |
| 2025 | 81 | 1 |
| 2026 | 69 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K911752 | Icon Teleradiology SystemSummary page 1…1996 A. LEGALLY MARKETED PREDICATE DEVICES The RadWorks™ Medical Imaging Software is substantially equivalent to the ICON Teleradiology System by ICON Medical Systems (K911752), and the Images-on-Call Teleradiology System by Devices and Services Company (K896095). B. DEVICE DESCRIPTION Section 1l of t… | 1991 |
| * | K896095 | Images-on-Call Teleradiology SystemSummary page 1…ubstantially equivalent to the ICON Teleradiology System by ICON Medical Systems (K911752), and the Images-on-Call Teleradiology System by Devices and Services Company (K896095). B. DEVICE DESCRIPTION Section 1l of this submission contains a detailed description of the RadWorks™ Medical Imaging Software… | 1990 |
What descends from it? (848)
See all 8489 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982862 | Radworks Medical Imaging Software with Quality Control Module | 1998 | 463 |
| K981535 | Focus Pilot Contouring Workstation | 1999 | 354 |
| K052411 | Hipax Medical Imaging Software | 2005 | 80 |
| K972701 | Barco MWD 321 Medical Workstation Display | 1998 | 38 |
| K012779 | Iconnection 3D | 2001 | 31 |
| K993761 | Cardiovascular Measurement System - View | 1999 | 6 |
| K983267 | Digora for Windows 2.0 | 1998 | 1 |
| K973081 | Digitizer Director: Image Compression Module (HO4059-Rev 2.0) | 1997 | 0 |
| K972933 | Vox/Base for Windows | 1997 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K982862 (Applicare Medical Imaging, B.V., 1998) has gone furthest, with 463 descendants of its own.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RadWorks™ Medical Imaging Software is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.
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/K962699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962699: Radworks Medical Imaging Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962699
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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