# K040688: Standard Imaging E.Imrt Calculator

- Pathway: 510(k) (Traditional)
- Applicant: Standard Imaging, Inc.
- Decided: May 11, 2004 after 56 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 5 generations back to K914698 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951581: PINNACLE3 Apex, Adac Laboratories (1996) Summary page 1.
- K993923: Adac PINNACLE3TM Radiation Therapy Planning System, Adac Laboratories (2000) Summary page 1.
- K032724: PINNACLE3 Radiation Therapy Planning System, Adac Laboratories (2003) Summary page 1.

## Indications for use
The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient. Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4, 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used. The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam treatment energies, in both numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts. Specific electron beam parameters are selected from the solution options provided by the e.IMRT Calculator for non-direct (manual) input into tlhe user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementatio with a linear accelerator.

Source page: https://510kreport.com/device/K040688
Methodology: https://510kreport.com/methodology