510(k) · Cleared
ClearedRsa-CMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medis Medical Imaging Systems BV · LLZ System, Image Processing, Radiological
Cleared on Oct 20, 2004 as substantially equivalent to K041162 (Medis Medical Imaging Systems BV, 2004) after a 49-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Oct 20, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 3 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 2 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 1 generation backK041162 Ortho-CMSMedis Medical Imaging Systems BV · 2004
- This deviceK042383 Rsa-CMSMedis Medical Imaging Systems BV · 2004
- Descendant · cites it directly · 0 of its ownK133966 Model-Based Rsa SoftwareHalifax Biomedical, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133966Model-Based Rsa SoftwareHalifax Biomedical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −3 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −2 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −1 | K041162 | Ortho-CMS | Medis Medical Imaging Systems BV | 2004 | — |
| 0 (this device) | K042383 | Rsa-CMS | Medis Medical Imaging Systems BV | 2004 | — |
| +1 | K133966 | Model-Based Rsa Software | Halifax Biomedical, Inc. | 2014 | — |
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 |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K041162 | Ortho-CMSSummary page 1…ystem Image Processing, Radiological. Regulation Number : 21 CFR 892.2050 (90 LLZ; Class II) 3. Predicate Device(s) Ortho-CMS of Medis K041162 4. Description of the device: by In orthopaedics clinical… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133966 | Model-Based Rsa Software | 2014 | 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 14 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K133966 (Halifax Biomedical, Inc., 2014) has gone furthest, with 0 descendants of its own.
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?
RSA-CMS has been developed for the objective and reproducible analysis on digital roentgen images (DICOM CR or DX) or digitised images in a PACS environment. Orthopedic specialist and core labs use the RSA-CMS standalone analytical software package in image post-processing for the evaluation of new implant designs, coatings and new cementation techniques in clinical trials. When interpreted by trained physicians these parameters may be useful to derive…
Read the full statement (108 words)
RSA-CMS has been developed for the objective and reproducible analysis on digital roentgen images (DICOM CR or DX) or digitised images in a PACS environment.
Orthopedic specialist and core labs use the RSA-CMS standalone analytical software package in image post-processing for the evaluation of new implant designs, coatings and new cementation techniques in clinical trials.
When interpreted by trained physicians these parameters may be useful to derive conclusions from these clinical trials.
RSA-CMS is developed in close cooperation with the Division of Image Processing (LKEB) and the Department of Orthopedics of the Leiden University Medical Center. It has been validated and complies with international safety and quality standards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042383: Rsa-CMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042383
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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