510(k) · Cleared
Recalled · Class II · 2018Mosaiq Oncology Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impac Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Dec 12, 2012 as substantially equivalent to K112930 (Mim Software, Inc., 2011) after a 58-day review. Its family tree reaches back 10 generations to 1996. 20 later devices descend from it. It has been recalled 7 times.
- Decided
- Dec 12, 2012
- Review
- 58 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 10 generations to K954874 (1996). 38 ancestors in all, the oldest K885054 (1989). 20 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations between
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
- This deviceK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012
- Descendant · cites it directly · 13 of its ownK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 12 of its ownK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 8 of its ownK203172 MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · Recalled
- Descendant · 4 generations on · 5 of its ownK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · cites it directly · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
Show all 10 generations
- Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 9 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 8 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 7 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 6 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 5 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 4 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 3 generations backK062163 MimviewerMimvista Corp. · 2006
- 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
- This deviceK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · cites it directly13descendants
- K183034MOSAIQ Oncology Information SystemElekta, Inc. · 2018 · 2 generations on12descendants
- K203172MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · 3 generations on8descendants
- K210645RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · 4 generations on5descendants
- K142142Quality ReportsSun Nuclear Corporation · 2014 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −9 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −8 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −7 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −6 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −5 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −4 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −3 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −2 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −1 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K123230 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | — |
| +1 | K141572 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2014 | 11 |
| +2 | K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018 | 2 |
| +3 | K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | 2020 | 1 |
| +4 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021 | 6 |
| +1 | K142142 | Quality Reports | Sun Nuclear Corporation | 2014 | — |
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 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
What descends from it? (20)
See all 202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2018 | Class II | Z-0821-2019 | Software change control | There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the… |
| Jun 21, 2017 | Class II | Z-2633-2017 | Software design | Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans. |
| Jul 15, 2016 | Class II | Z-2293-2016 | Software Design Change | It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. |
| Nov 3, 2014 | Class II | Z-0221-2015 | Software design | A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports. |
| May 29, 2014 | Class II | Z-1869-2014 | Software design | MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order. |
| May 23, 2014 | Class II | Z-1800-2014 | Software design | When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a… |
| Dec 20, 2012 | Class II | Z-1077-2013 | Software design | A potential safety risk with the MOSAIQ Oncology Information System that has been identified by the manufacturer IMPAC Medical Systems, Inc. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 38 ancestors have a recall of any class.
- Of its descendants, K141572 (Impac Medical Systems, Inc., 2014) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K112930.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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. It lets users: * Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe…
Read the full statement (228 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. 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 multileaf 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.
MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123230: Mosaiq Oncology Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123230
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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