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 Feb 28, 2012 as substantially equivalent to K043412 (Impac Medical Systems, Inc., 2004) and 3 other predicates after a 50-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 28, 2012
- Review
- 50 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 3 generations to K942346 (1995). 10 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK942346 ImagertImpac Medical Systems, Inc. · 1995
- 2 generations backK011694 ViewstationImpac Medical Systems, Inc. · 2001
- 1 generation backK043412 Modification to: ViewstationImpac Medical Systems, Inc. · 2004
- This deviceK120067 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
- Descendant · 2 generations on · 4 of its ownK162468 ClearCheckRadformation · 2016
- Descendant · 3 generations on · 3 of its ownK220583 ClearCheck Model RADCC V2Radformation, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK231185 MapRTVision Rt, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK122616 Panther Ois/R & V Model Version 2.0Prowess, Inc. · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142142Quality ReportsSun Nuclear Corporation · 2014 · cites it directly5descendants
- K162468ClearCheckRadformation · 2016 · 2 generations on4descendants
- K220583ClearCheck Model RADCC V2Radformation, Inc. · 2022 · 3 generations on3descendants
- K231185MapRTVision Rt, Ltd. · 2023 · 4 generations on1descendant
- K122616Panther Ois/R & V Model Version 2.0Prowess, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942346 | Imagert | Impac Medical Systems, Inc. | 1995 | — |
| −2 | K011694 | Viewstation | Impac Medical Systems, Inc. | 2001 | — |
| −1 | K043412 | Modification to: Viewstation | Impac Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K120067 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | — |
| +1 | K142142 | Quality Reports | Sun Nuclear Corporation | 2014 | — |
| +2 | K162468 | ClearCheck | Radformation | 2016 | — |
| +3 | K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022 | — |
| +4 | K231185 | MapRT | Vision Rt, Ltd. | 2023 | — |
| +1 | K122616 | Panther Ois/R & V Model Version 2.0 | Prowess, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K043412 | Modification to: ViewstationSummary page 2…States. MOSAIQ is substantially equivalent to these products in intended use and safety and effectiveness. 1. ViewStation IMPAC Medical Systems, Inc. K043412 2. SEQUENCER IiMPAC Medical Systems, Inc. K98 1313 3. MLC Fit IMPAC Medical Systems, Inc. K991133… | 2004 |
| * | K981313 | SequencerSummary page 2…tended use and safety and effectiveness. 1. ViewStation IMPAC Medical Systems, Inc. K043412 2. SEQUENCER IiMPAC Medical Systems, Inc. K98 1313 3. MLC Fit IMPAC Medical Systems, Inc. K991133 4. ARIA Radiation Oncology Varian Medical Systems… | 1998 |
| * | K991133 | MLC FitSummary page 2…IMPAC Medical Systems, Inc. K043412 2. SEQUENCER IiMPAC Medical Systems, Inc. K98 1313 3. MLC Fit IMPAC Medical Systems, Inc. K991133 4. ARIA Radiation Oncology Varian Medical Systems K093527 MOSATO INTENDED USE MOSAIQ is an image-enabled elect… | 2000 |
| * | K093527 | Aria Radiation Oncology with MirsSummary page 2…PAC Medical Systems, Inc. K98 1313 3. MLC Fit IMPAC Medical Systems, Inc. K991133 4. ARIA Radiation Oncology Varian Medical Systems K093527 MOSATO INTENDED USE MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. I… | 2009 |
What descends from it? (8)
2 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… |
| Sep 18, 2012 | Class II | Z-0169-2013 | Device Design | A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. |
| Jun 8, 2012 | Class II | Z-1944-2012 | Software design | Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 6.3 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K142142 (Sun Nuclear Corporation, 2014) has gone furthest, with 5 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. 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 supports information flow among healthcare facility personnel. It can be used wherever radiotherapy and/or chemotherapy are prescribed. 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/K120067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120067: Mosaiq 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/K120067
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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