510(k) · Cleared
Recalled · 2011Leksell Gammaplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patterson Consulting Group, Inc. · IWB System, Radiation Therapy, Radionuclide
Cleared on Apr 1, 1998 as substantially equivalent to K914808 (Elekta Instruments, Inc., 1992) after a 202-day review. Its family tree reaches back 1 generation to 1992. 12 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 1, 1998
- Review
- 202 days
- Class
- Class II
- Product code
- IWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914808 (1992). 12 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK914808 Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992
- This deviceK973441 Leksell GammaplanPatterson Consulting Group, Inc. · 1998
- Descendant · cites it directly · 11 of its ownK042269 Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004
- Descendant · cites it directly · 10 of its ownK051022 GammaplanElekta Instrument AB · 2005
- Descendant · cites it directly · 9 of its ownK061540 Leksell GammaplanElekta Instrument AB · 2006
- Descendant · cites it directly · 6 of its ownK090972 Leksell GammaplanElekta Instrument AB · 2009
- Descendant · 2 generations on · 5 of its ownK103093 Leksell GammaplanElekta Instrument AB · 2010 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K042269Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004 · cites it directly11descendants
- K051022GammaplanElekta Instrument AB · 2005 · cites it directly10descendants
- K061540Leksell GammaplanElekta Instrument AB · 2006 · cites it directly9descendants
- K090972Leksell GammaplanElekta Instrument AB · 2009 · cites it directly6descendants
- K103093Leksell GammaplanElekta Instrument AB · 2010 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914808 | Leksell Gammaplan (LGP) | Elekta Instruments, Inc. | 1992 | — |
| 0 (this device) | K973441 | Leksell Gammaplan | Patterson Consulting Group, Inc. | 1998 | — |
| +1 | K042269 | Leksell Gammaplan 4C with Multiview | Elekta Instrument AB | 2004 | — |
| +1 | K051022 | Gammaplan | Elekta Instrument AB | 2005 | — |
| +1 | K061540 | Leksell Gammaplan | Elekta Instrument AB | 2006 | — |
| +1 | K090972 | Leksell Gammaplan | Elekta Instrument AB | 2009 | — |
| +2 | K103093 | Leksell Gammaplan | Elekta Instrument AB | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 IWB? 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 IWB device
- #1 K250391 Leksell Gamma Knife® (Elekta Esprit); Leksell…score 11.2 · 13 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 |
|---|---|---|---|
| * | K914808 | Leksell Gammaplan (LGP)Summary page 1…ument, AB September 2, 1997 Leksell GammaPlan® Radionuclide radiation therapy system. CFR 892.5750 510(k) No. Date Cleared Elekta Instrument, AB Leksell GammaPlan® K914808 January 23, 1992 Do 0O w 19.4 19.5 19.6 DEVICE DESCRIPTION The Leksell GammaPlan® is a computer based dose… | 1992 |
What descends from it? (12)
See all 124 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 |
|---|---|---|---|---|
| Jun 23, 2011 | Not classified | Z-0307-2012 | Labeling False and Misleading | There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription… |
| Oct 23, 2008 | Not classified | Z-1134-2010 | Other | Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image… |
| Jan 7, 2008 | Not classified | Z-1604-2010 | Other | The precision of the calculation used to create the fused study in LGP 8.0 is too low and should not be used until the system is upgraded to LGP 8.2. |
| Oct 1, 2005 | Not classified | Z-1223-2011 | Other | Investigation found that if a user accidentally selects the wrong image/tube position images can be displayed flipped. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IWB devicesIWB System, Radiation Therapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IWB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IWB
57in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IWB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IWB
3in 2025
MAUDE reports naming product code IWB, 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 | — | 3 | 8 |
| 2008 | 0 | — | 3 | 15 |
| 2009 | 1 | — | 1 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 3 | 170 | 1 | 8 |
| 2015 | 3 | 79 | 0 | 5 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 3 | 57 | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Leksell GammaPlan (LGP) is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument, AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professionals (Neurosurgeons, Radiation Therapists, Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium.
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/K973441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973441: Leksell Gammaplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973441
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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