510(k) · Cleared
Recalled · Class II · 2018Sequencer
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 Jul 9, 1998 after a 90-day review. The FDA summary names no predicate by number. 9 later devices descend from it. It has been recalled 11 times.
- Decided
- Jul 9, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 11
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK981313 SequencerImpac Medical Systems, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK120067 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
- Descendant · 3 generations on · 4 of its ownK162468 ClearCheckRadformation · 2016
- Descendant · 4 generations on · 3 of its ownK220583 ClearCheck Model RADCC V2Radformation, Inc. · 2022
- Descendant · 5 generations on · 1 of its ownK231185 MapRTVision Rt, Ltd. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · cites it directly8descendants
- K142142Quality ReportsSun Nuclear Corporation · 2014 · 2 generations on5descendants
- K162468ClearCheckRadformation · 2016 · 3 generations on4descendants
- K220583ClearCheck Model RADCC V2Radformation, Inc. · 2022 · 4 generations on3descendants
- K231185MapRTVision Rt, Ltd. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981313 | Sequencer | Impac Medical Systems, Inc. | 1998 | — |
| +1 | K120067 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 3 |
| +2 | K142142 | Quality Reports | Sun Nuclear Corporation | 2014 | — |
| +3 | K162468 | ClearCheck | Radformation | 2016 | — |
| +4 | K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022 | — |
| +5 | K231185 | MapRT | Vision Rt, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120067 | Mosaiq Oncology Information System | 2012 | 8 |
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… |
| Feb 14, 2012 | Not classified | Z-1270-2012 | Device Design | Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A |
| Sep 9, 2011 | Not classified | Z-0052-2012 | Nonconforming Material/Component | Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq. |
| Mar 10, 2011 | Not classified | Z-2662-2011 | Software design (manufacturing process) | There's a problem in the database conversion program that is used when upgrading from the Multi-ACCS to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be… |
| Sep 2, 2010 | Not classified | Z-0076-2011 | Software design | Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient. |
| Mar 10, 2010 | Not classified | Z-1029-2011 | Software design | Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field. |
| Feb 19, 2010 | Not classified | Z-0159-2011 | Process change control | Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original… |
| Jul 17, 2009 | Not classified | Z-1027-2011 | Software design | Potential for improper treatment. A software error may result in potential major underdosing to targeted areas from jaw blockage of the MLC aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw… |
| Feb 14, 2008 | Not classified | Z-1515-2008 | Software design | Software issue may result in change to intended treatment field, potentially resulting in mistreatment. |
| Jul 7, 2006 | Not classified | Z-1401-06 | Software design | Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format. |
| Jan 6, 2005 | Not classified | Z-0364-06 | Software design | When using the Creatine Clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. This miscalculation may result in patients less than two years old to be… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120067 (Impac Medical Systems, Inc., 2012) 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.
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?
SEQUENCER is to be used to facilitate the delivery of defined radiotherapy treatment plans. SEQUENCER verifies the settings on a radiotherapy treatment machine prior to treatment and records the actual parameters after treatment. SEQUENCER can be used whenever radiotherapy treatment is prescribed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981313: Sequencer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981313
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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