# K052315: Simtec IM-Maxx 2 Option

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 22, 2005 after 28 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914698 (1992). 26 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993425: Primus, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K031764: Oncor Avant-Garde with Coherence Workspaces, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.

## Most influential descendants
- K121295: Artistetm Solution with Sys Vcio (2012), 3 descendants of its own
- K132935: Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit, Aria Connectivity Option for Sieme (2014), 2 descendants of its own
- K142434: Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist Workspaces, V4.3.1_MR1 (2014), 1 descendant of its own
- K182050: Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K052315
Methodology: https://510kreport.com/methodology