510(k) · Cleared
ClearedGE Target Series 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · KPQ System, Simulation, Radiation Therapy
Cleared on Dec 22, 1989 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 61 later devices descend from it.
- Decided
- Dec 22, 1989
- Review
- 46 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 3 citing it directly.
- This deviceK896353 GE Target Series 2GE Medical Systems · 1989
- Descendant · cites it directly · 57 of its ownK940663 Peacock PlanNomos Corp. · 1996
- Descendant · cites it directly · 31 of its ownK963258 Peacock SystemNomos Corp. · 1996
- Descendant · 2 generations on · 27 of its ownK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
- Descendant · 3 generations on · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K940663Peacock PlanNomos Corp. · 1996 · cites it directly57descendants
- K963258Peacock SystemNomos Corp. · 1996 · cites it directly31descendants
- K984532Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999 · 2 generations on27descendants
- K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999 · 2 generations on24descendants
- K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896353 | GE Target Series 2 | GE Medical Systems | 1989 | — |
| +1 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| +1 | K963258 | Peacock System | Nomos Corp. | 1996 | — |
| +2 | K984532 | Cadplan Helios Option 6.0 | Varian Medical Systems, Inc. | 1999 | — |
| +2 | K993766 | Helax-TMS V 5.0 Radiation Therapy Treatment Planning System | Helax AB | 1999 | — |
| +3 | K010682 | Helax-TMS V 5.1 Radiation Therapy Treatment Planning System | Mds Nordion | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (61)
See all 613 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K940663 (Nomos Corp., 1996) has gone furthest, with 57 descendants of its own.
How does its category compare?
All KPQ devicesKPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KPQ
Too few KPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPQ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPQ
1in 2020
MAUDE reports naming product code KPQ, 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 | 1 | — | 6 | 17 |
| 2008 | 1 | — | 3 | 12 |
| 2009 | 1 | — | 1 | 7 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 1 | 11 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K896353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K896353: GE Target Series 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896353
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026