# K082775: Prescision Option

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 19, 2009 after 150 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K914698 (1992). 45 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072485: Artiste MV SA, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K060226: Oncor Expression, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K993425: Primus, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K061140: Trilogy Radiotherapy Delivery System, Varian Medical Systems (2006) Summary page 1.
- K060912: Modification to: HI-Art System, Tomotherapy Incorporated (2006) Summary page 1.
- K052325: Cyberknife System for Stereotactic Radiosurgery/Radiotherapy, Accuray Incorporated (2005) Summary page 1.

## Most influential descendants
- K090683: Syngo RT Therapist Connect (2009), 7 descendants of its own
- K102671: Syngo RT Therapist Connect Workspace, V4.2 (2010), 5 descendants of its own
- K103606: Artiste Solution with Sys_VB50 Update (2011), 4 descendants of its own
- K092145: 160MLC Option (2009), 4 descendants of its own
- K123812: Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv (2013), 3 descendants of its own

## Indications for use
The intended use of the SIEMENS branded ARTISTE TM, ONCOR™ and PRIMUS TM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The LINAC is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, tumors and conditions anywhere in the body where radiation therapy is indicated. The syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

Source page: https://510kreport.com/device/K082775
Methodology: https://510kreport.com/methodology