510(k) · Cleared
ClearedSimtec IM-Maxx 2 Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 22, 2005 as substantially equivalent to K993425 (Siemens Medical Solutions USA, Inc., 1999) and 1 other predicate after a 28-day review. Its family tree reaches back 7 generations to 1992. 4 later devices descend from it.
- Decided
- Sep 22, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K914698 (1992). 26 ancestors in all, the oldest K862339 (1986). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 6 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 5 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 4 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 3 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 1 generation backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- This deviceK052315 Simtec IM-Maxx 2 OptionSiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK121295 Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK132935 Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace…Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK142434 Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT…Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK182050 Linear Accelerator Control Console Software v13.1.010 Update, syngo…Siemens Medical Solutions USA, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc. · 2012 · cites it directly3descendants
- K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on2descendants
- K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on1descendant
- K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −6 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −5 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −4 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −3 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −2 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| 0 (this device) | K052315 | Simtec IM-Maxx 2 Option | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +1 | K121295 | Artistetm Solution with Sys Vcio | Siemens Medical Solutions USA, Inc. | 2012 | 5 |
| +2 | K132935 | Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +2 | K142434 | Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT… | Siemens Medical Solutions USA, Inc. | 2014 | 5 |
| +3 | K182050 | Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation… | Siemens Medical Solutions USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 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? (2)
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 |
|---|---|---|---|
| * | K993425 | PrimusSummary page 1…(Accessory To) - Accelerator, Linear, Medical Classification: 892.5050 Product Code: lYE Substantial Equivalence Claimed To: *K993425 - PRIMUS Linear Accelerator, cleared on Nov. 26, 1999. *K031764 - ONCOR Avant-Garde with COHERENCE Workspaces, cleared on… | 1999 |
| * | K031764 | Oncor Avant-Garde with Coherence WorkspacesSummary page 1…on: 892.5050 Product Code: lYE Substantial Equivalence Claimed To: *K993425 - PRIMUS Linear Accelerator, cleared on Nov. 26, 1999. *K031764 - ONCOR Avant-Garde with COHERENCE Workspaces, cleared on Sept 5, 2003 Historical Information and Device Description: The radi… | 2003 |
| † | K882729 | Mevatron, M 2 Class | 1988 |
| † | K972275 | Lantis Treatstation | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121295 | Artistetm Solution with Sys Vcio | 2012 | 3 |
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?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 9 of the 26 ancestors have a recall of any class.
- Of its descendants, K121295 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K993425.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to deliver x-ray radiation for the therapeutic treatment of cancer. The SIMTEC IM-MAXX, software application is an optional software accessory to these devices and is indicated where a specific method of treatment delivery, commercially marketed as Fast Intensity Modulated Radiation Therapy (FIMRT), is prescribed by a licensed medical oncologist. The SIMTEC IM-MAXX 2…
Read the full statement (104 words)
The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to
deliver x-ray radiation for the therapeutic treatment of cancer.
The SIMTEC IM-MAXX, software application is an optional software accessory to these devices
and is indicated where a specific method of treatment delivery, commercially marketed as Fast
Intensity Modulated Radiation Therapy (FIMRT), is prescribed by a licensed medical oncologist.
The SIMTEC IM-MAXX 2 software option is intended to further enhance the speed of delivery of the
Fast Intensity Modulated Radiation Therapy (FIMRT) treatment delivery technique. The
indications for use of this accessory has remained unchanged as a result of the modification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052315: Simtec IM-Maxx 2 Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052315
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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