510(k) · Cleared
Recalled · Class II · 2021MOSAIQ Oncology Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta, Inc. · IYE Accelerator, Linear, Medical
Cleared on Dec 4, 2018 as substantially equivalent to K141572 (Impac Medical Systems, Inc., 2014) after a 33-day review. Its family tree reaches back 12 generations to 1996. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 4, 2018
- Review
- 33 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 12 generations to K954874 (1996). 45 ancestors in all, the oldest K885054 (1989). 12 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations between
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- 1 generation backK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- This deviceK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018
- Descendant · cites it directly · 8 of its ownK203172 MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · Recalled
- Descendant · 2 generations on · 5 of its ownK210645 RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 3 generations on · 4 of its ownK211867 RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · Recalled
- Descendant · 4 generations on · 3 of its ownK220141 RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · Recalled
- Descendant · 5 generations on · 2 of its ownK222312 RayStation 12ARaySearch Laboratories AB (PUBL) · 2023 · Recalled
Show all 12 generations
- Root · 12 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 10 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 9 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 8 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 7 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 6 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 5 generations backK062163 MimviewerMimvista Corp. · 2006
- 4 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 3 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 2 generations backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- 1 generation backK141572 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2014 · Recalled
- This deviceK183034 MOSAIQ Oncology Information SystemElekta, Inc. · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K203172MOSAIQ Oncology Information SystemElekta Solutions AB · 2020 · cites it directly8descendants
- K210645RayStation 10.1RaySearch Laboratories AB (PUBL) · 2021 · 2 generations on5descendants
- K211867RayStation 11.0RaySearch Laboratories AB (PUBL) · 2021 · 3 generations on4descendants
- K220141RayStation 11BRaySearch Laboratories AB (PUBL) · 2022 · 4 generations on3descendants
- K222312RayStation 12ARaySearch Laboratories AB (PUBL) · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −11 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −10 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −9 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −8 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −7 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −6 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −5 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −4 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −3 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K123230 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 7 |
| −1 | K141572 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2014 | 11 |
| 0 (this device) | K183034 | MOSAIQ Oncology Information System | Elekta, Inc. | 2018 | — |
| +1 | K203172 | MOSAIQ Oncology Information System | Elekta Solutions AB | 2020 | 1 |
| +2 | K210645 | RayStation 10.1 | RaySearch Laboratories AB (PUBL) | 2021 | 6 |
| +3 | K211867 | RayStation 11.0 | RaySearch Laboratories AB (PUBL) | 2021 | 8 |
| +4 | K220141 | RayStation 11B | RaySearch Laboratories AB (PUBL) | 2022 | 6 |
| +5 | K222312 | RayStation 12A | RaySearch Laboratories AB (PUBL) | 2023 | 6 |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K141572 | Mosaiq Oncology Information SystemSummary page 5…stantially equivalent to the following product in intended use and safety and effectiveness. MOSAIQ Oncology Information System IMPAC Medical Systems, Inc. K141572 REFERENCE DEVICE INFORMATION The MOSAIQ Oncology Information is using the following device as a reference device to demonstrate… | 2014 |
| † | K162393 | The ViewRay (MRIdian) Linac System | 2017 |
What descends from it? (12)
See all 122 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 |
|---|---|---|---|---|
| Sep 2, 2021 | Class II | Z-2591-2021 | Software design | A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value. |
| Apr 20, 2021 | Class II | Z-1783-2021 | Under Investigation by firm | Malware attack |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 10 of the 45 ancestors have a recall of any class.
- Of its descendants, K203172 (Elekta Solutions AB, 2020) has gone furthest, with 8 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 (248 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.
• Use stereotactic localization to calculate set-up coordinates for treatments.
• Observation of Intrafractional motion with real time image overlay.
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/K183034 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183034: 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/K183034
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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