← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K973540

# ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS (K973540)

_Elekta Oncology Systems, Inc. · IYE · Dec 17, 1997 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K973540

## Device Facts

- **Applicant:** Elekta Oncology Systems, Inc.
- **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md)
- **Decision Date:** Dec 17, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5050
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Therapeutic

## Indications for Use

The EOS iCom/QuickMode Software Options, as with the predicate SLi Series system, is intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

## Device Story

iCom/QuickMode Software Options are enhancements for existing SLi Series Linear Accelerators; used in clinical radiation therapy settings by trained medical professionals. Software integrates with existing accelerator hardware to improve operational efficiency. Device does not introduce new hazards; maintains compliance with established safety standards (IEC 601-1, IEC 601-2-1). Healthcare providers utilize the software to manage radiation delivery parameters for cancer treatment. Benefits include improved workflow and continued safe delivery of therapeutic radiation to patients with malignant neoplastic diseases.

## Clinical Evidence

No clinical data. The submission relies on bench testing, hazard analysis, and compliance with internationally recognized safety standards (IEC 601-1, IEC 601-2-1, IEC 950, UL 1950) to demonstrate safety and effectiveness.

## Technological Characteristics

Software enhancement for SLi Series Linear Accelerators. Operates within existing hardware infrastructure. Compliance with IEC 601-1, IEC 601-2-1, IEC 950, and UL 1950. Quality system certified to ISO 9001, EN 46001, and 21 CFR 820 GMP.

## Regulatory Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

## Predicate Devices

- SLi Series Linear Accelerators ([K973540](/device/K973540.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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Elekta Oncology Systems Ltd hereby provide the following material summarising safety and effectiveness information for the Elekta Oncology Systems iCom/QuickMode Software Options. This information is summarised as follows:-

s summarised
K973540

- The iCom/QuickMode Software Options are improvements to the 1) DEC 17 1997 existing SLi Series Linear Accelerators which have previously been cleared for commercial distribution. These devices have an established and proven track record for safety. The iCom/QuickMode Software Options do not raise additional types of safety or effectiveness considerations when installed on the SLi Series Linear Accelerators.
- The accompanying documents provided for the user contain 2) comprehensive information to ensure safe and effective use. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed by the accompanying documents provided for the user.
- It is our opinion that when the iCom/QuickMode Software Options are 3) installed on the SLi Series Linear Accelerators they do not have technological characteristics that raise additional types of safety or effectiveness questions, and that we consider them an enhancement to the existing SLi Series Linear Accelerators.
- The SLi Series Linear Accelerators have been subject to compliance 4) testing as defined in the internationally recognised safety standards IEC 601-1 and IEC 601-2-1. As appropriate, proprietary information technology equipment is procured to the internationally recognised standards IEC 950 and/or UL 1950.
- All products bear the CE mark affirming compliance with all relevant ર) European Directives in force. In particular compliance has been assured to the European Medical Device Directive and the European Electromagnetic Compatibility Directive. As a result of this products may be sold freely without restriction throughout the entire European Union.
- The SLi Series Linear Accelerators have been designed to ensure that () compliance to the above standards is maintained.
- Elekta Oncology Systems is a registered medical device manufacturer of 7) assessed capability against the requirements of ISO 9001, EN 46001, and the Medical Device Directive, 93/42/EEC Annex II.

| REF: 804/<br>PC52MA07637<br>MO7QA054                    | Summary of Safety & Effectiveness<br>Information for the Elekta Oncology Systems<br>iCom/QuickMode Software Options | N.C. 4513 361 8927<br>Attachment No: 7 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------|
|                                                         |                                                                                                                     | Page 1 of 2 21/08/97                   |
| © 1997 Elekta Oncology Systems Ltd. All rights reserved |                                                                                                                     |                                        |
| ELEKTA ONCOLOGY SYSTEMS LTD, CRAWLEY. UK.               |                                                                                                                     |                                        |

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- Elekta Oncology Systems Software Quality System has been established 8) to satisfy the requirements of ISO 9001, EN 46001, the Medical Device Directive, 93/42/EEC Annex II, and the US 21 CFR 820 GMP. Elekta Oncology Systems has developed the iCom/QuickMode Software Options using an established and documented Software Quality Management System.
- In accordance with the above requirements all parts of the Quality 9) System are subject to periodic and systematic internal Quality Audits. These audits are performed by trained personnel not having direct responsibilities in the functions being audited.
- Additionally the quality system is subject to regular, planned and 10) documented GMP audits conducted by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
- Elekta Oncology Systems has conducted hazard analysis on the Philips 11) SLi Series Linear Accelerators and the iCom/QuickMode Software Options and have concluded that it does not introduce hazards that raise new type of safety or effectiveness considerations and that the level of concern appropriate to the device is high.

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