510(k) · Cleared
ClearedRayCare 2.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
RaySearch Laboratories AB (PUBL) · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 8, 2019 as substantially equivalent to K183034 (Elekta, Inc., 2018) after a 46-day review. Its family tree reaches back 13 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 8, 2019
- Review
- 46 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K954874 (1996). 46 ancestors in all, the oldest K885054 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations between
- 3 generations backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- 2 generations backK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- 1 generation backK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- This deviceK191384 RayCare 2.3RaySearch Laboratories AB (PUBL) · 2019
- Descendant · cites it directly · 1 of its ownK200487 RayCare 3.1RaySearch Laboratories AB (PUBL) · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK242992 RayCare (2024A SP1)RaySearch Laboratories AB (PUBL) · 2025 · Recalled
Show all 13 generations
- Root · 13 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 11 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 10 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 9 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 8 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 7 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 6 generations backK062163 MimviewerMimvista Corp. · 2006
- 5 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 4 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 3 generations backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- 2 generations backK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- 1 generation backK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- This deviceK191384 RayCare 2.3RaySearch Laboratories AB (PUBL) · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −12 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −11 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −10 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −9 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −8 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −7 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −6 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −5 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −4 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K123230 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 7 |
| −2 | K141572 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2014 | 11 |
| −1 | K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018 | 2 |
| 0 (this device) | K191384 | RayCare 2.3 | RaySearch Laboratories AB (PUBL) | 2019 | — |
| +1 | K200487 | RayCare 3.1 | RaySearch Laboratories AB (PUBL) | 2020 | 5 |
| +2 | K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K183034 | MOSAIQ Oncology Information SystemSummary page 4…reatment planning system 5.6 Classification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate device K183034, MOSAIQ Oncology Information System 5.8 Device description RayCare is an oncology information system that supports healthc… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200487 | RayCare 3.1 | 2020 | 1 |
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 23 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 46 ancestors have a recall of any class.
- Of its descendants, K200487 (RaySearch Laboratories AB (PUBL), 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K183034.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
RayCare is an oncology information system used to support workflows, scheduling and clinical information management
for oncology care and follow-up. RayCare may be used in the transfer, storage, conversion and display of patient data in
all areas of cancer care including radiation therapy, medical oncology and surgical oncology.
RayCare is not intended for use in diagnostic activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191384: RayCare 2.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191384
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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