510(k) · Cleared
Recalled · Class II · 2026RayCare (2024A SP1)
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 Apr 17, 2025 as substantially equivalent to K200487 (RaySearch Laboratories AB (PUBL), 2020) after a 203-day review. Its family tree reaches back 15 generations to 1996. It has been recalled 2 times.
- Decided
- Apr 17, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 15 generations to K954874 (1996). 48 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations between
- 3 generations backK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- 2 generations backK191384 RayCare 2.3RaySearch Laboratories AB (PUBL) · 2019
- 1 generation backK200487 RayCare 3.1RaySearch Laboratories AB (PUBL) · 2020 · Recalled
- This deviceK242992 RayCare (2024A SP1)RaySearch Laboratories AB (PUBL) · 2025
Show all 15 generations
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 14 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 13 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 12 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 11 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 10 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 9 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 8 generations backK062163 MimviewerMimvista Corp. · 2006
- 7 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 6 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 5 generations backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- 4 generations backK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- 3 generations backK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- 2 generations backK191384 RayCare 2.3RaySearch Laboratories AB (PUBL) · 2019
- 1 generation backK200487 RayCare 3.1RaySearch Laboratories AB (PUBL) · 2020 · Recalled
- This deviceK242992 RayCare (2024A SP1)RaySearch Laboratories AB (PUBL) · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −14 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −13 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −12 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −11 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −10 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −9 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −8 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −7 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K123230 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 7 |
| −4 | K141572 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2014 | 11 |
| −3 | K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018 | 2 |
| −2 | K191384 | RayCare 2.3 | RaySearch Laboratories AB (PUBL) | 2019 | — |
| −1 | K200487 | RayCare 3.1 | RaySearch Laboratories AB (PUBL) | 2020 | 5 |
| 0 (this device) | K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K200487 | RayCare 3.1Summary page 6…5050 Product Code(s) MUJ Page 1 of 12 III. Legally Marketed Predicate Device Predicate # K200487 Predicate Trade Name RayCare 3B Product Code MUJ IV. Device Description Summary RayCare is an oncology information… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2026 | Class II | Z-2646-2026 | Under Investigation by firm | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. |
| May 20, 2026 | Class II | Z-2647-2026 | Under Investigation by firm | Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 48 ancestors have a recall of any class.
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. 2025, 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 intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology. For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment…
Read the full statement (115 words)
RayCare is an oncology information system intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology.
For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment course and monitor the treatment course.
In the context of radiation therapy, the RayCare image viewer can be used for viewing images, annotating images, performing and saving image registrations as well as image fusion to enable offline image review of patient positioning during treatment delivery.
RayCare is not intended for use in diagnostic activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242992: RayCare (2024A SP1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242992
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