510(k) · Cleared
Recalled · Class II · 2023RayCare 3.1
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 Jun 10, 2020 as substantially equivalent to K191384 (RaySearch Laboratories AB (PUBL), 2019) after a 104-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jun 10, 2020
- Review
- 104 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 14 generations to K954874 (1996). 47 ancestors in all, the oldest K885054 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations between
- 3 generations backK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- 2 generations backK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- 1 generation backK191384 RayCare 2.3RaySearch Laboratories AB (PUBL) · 2019
- This deviceK200487 RayCare 3.1RaySearch Laboratories AB (PUBL) · 2020
- Descendant · cites it directly · 0 of its ownK242992 RayCare (2024A SP1)RaySearch Laboratories AB (PUBL) · 2025 · Recalled
Show all 14 generations
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 13 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 12 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 11 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 10 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 9 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 8 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 7 generations backK062163 MimviewerMimvista Corp. · 2006
- 6 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 5 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 4 generations backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- 3 generations backK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- 2 generations backK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- 1 generation backK191384 RayCare 2.3RaySearch Laboratories AB (PUBL) · 2019
- This deviceK200487 RayCare 3.1RaySearch Laboratories AB (PUBL) · 2020
Most influential descendants
Showing 1 of 1 · See all- K242992RayCare (2024A SP1)RaySearch Laboratories AB (PUBL) · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −13 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −12 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −11 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −10 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −9 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −8 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −7 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −6 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −4 | K123230 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 7 |
| −3 | K141572 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2014 | 11 |
| −2 | K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018 | 2 |
| −1 | K191384 | RayCare 2.3 | RaySearch Laboratories AB (PUBL) | 2019 | — |
| 0 (this device) | K200487 | RayCare 3.1 | RaySearch Laboratories AB (PUBL) | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K191384 | RayCare 2.3Summary page 4…atment planning system 5.6 Classification name Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ) 5.7 Predicate device K191384, RayCare 2.3 Oncology Information System Product code: MUJ, Regulation number: 892.5050 5.8 Device description RayC… | 2019 |
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 |
|---|---|---|---|
| K242992 | RayCare (2024A SP1) | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2023 | Class II | Z-0206-2024 | Under Investigation by firm | An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or… |
| Jul 17, 2023 | Class II | Z-2464-2023 | Under Investigation by firm | An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances |
| Jun 8, 2021 | Class II | Z-2138-2021 | Under Investigation by firm | Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point. |
| Mar 3, 2021 | Class II | Z-1281-2021 | Software design | Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later |
| Jul 29, 2020 | Class II | Z-2899-2020 | Under Investigation by firm | When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the treatment image related to the fraction and the planning image selected. When starting… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 47 ancestors have a recall of any class.
- Of its descendants, K242992 (RaySearch Laboratories AB (PUBL), 2025) has gone furthest, with 0 descendants of its own.
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. 2020, 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 and scheduling, as well as
clinical information, planning and treatment management for oncology care. 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/K200487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200487: RayCare 3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200487
Report an extraction error
Are you the manufacturer?
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