510(k) · Cleared
Recalled · Class II · 2026MOSAIQ® OIS (Oncology Information System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Solutions AB · IYE Accelerator, Linear, Medical
Cleared on Feb 23, 2023 as substantially equivalent to K203172 (Elekta Solutions AB, 2020) after a 128-day review. Its family tree reaches back 14 generations to 1996. It has been recalled 4 times.
- Decided
- Feb 23, 2023
- Review
- 128 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 14 generations to K954874 (1996). 47 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.
- 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 backK203172 MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · Recalled
- This deviceK223229 MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB · 2023
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 backK203172 MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · Recalled
- This deviceK223229 MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB · 2023
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 | K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | 2020 | 1 |
| 0 (this device) | K223229 | MOSAIQ® OIS (Oncology Information System) | Elekta Solutions AB | 2023 | — |
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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K203172 | MOSAIQ Oncology Information SystemSummary page 4…Medical charged-particle radiation therapy system Product Code: IYE III. PREDICATE DEVICE Predicate Device: MOSAIQ OIS (K203172) IV. DEVICE DESCRIPTION The MOSAIQ® Oncology Information System (OIS) is an image-enabled electronic medical re… | 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 21, 2026 | Class II | Z-2406-2026 | Software design | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. |
| Dec 10, 2025 | Class II | Z-1078-2026 | Software change control | Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs… |
| Sep 17, 2025 | Class II | Z-0503-2026 | Software design | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. |
| Jan 15, 2025 | Class II | Z-1162-2025 | Software design | Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 47 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203172.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. Medical oncology dose calculations are designed to support both adult and pediatric patients. It lets users: •…
Read the full statement (244 words)
MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. Medical oncology dose calculations are designed to support both adult and pediatric patients.
It lets users:
• Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
• Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.
• Import, view, annotate, adjust, enhance, manage and archive images.
• Compare radiation treatment plans and evaluate dose coverage.
• Design leaf plans for operation with radiotherapy treatment machines that have multi-leaf collimators.
• Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.
• View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup and communicates patient and machine setup instructions.
• Record actual delivered radiation values in an electronic chart to track treatment.
• Use stereotactic localization to calculate set-up coordinates for treatments.
• Monitor Intrafractional motion with real time image overlay.
MOSAIQ® is not intended for use in diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223229: MOSAIQ® OIS (Oncology Information System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223229
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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