VISION

K042956 · Varian Medical Systems, Inc. · IYE · Mar 11, 2005 · Radiology

Device Facts

• Record ID: K042956
• Device Name: VISION
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Mar 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Vision is a plan and image management application that is intended to enable an authorized user to enter, access, modify, store and archive plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

Device Story

Vision (formerly Varis Images) is a treatment plan and image management application for radiation therapy. It enables authorized users to enter, access, modify, store, and archive data from diagnostic studies, treatment planning, simulation, plan verification, and treatment delivery. The system stores treatment histories, including delivered dose to defined sites, and provides tools for verifying performed treatments. It is used by radiation therapy staff in clinical settings to manage patient data and ensure quality assurance of radiotherapy procedures. By centralizing plan and image management, the device assists clinicians in workflow efficiency and treatment verification, ultimately supporting the delivery of radiation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based plan and image management application. Functions include data entry, access, modification, storage, and archiving of diagnostic and radiotherapy planning data. Provides tools for treatment history storage and verification. Operates as a management system for radiation therapy workflows.

Indications for Use

Indicated for use by radiation therapy staff to assist in the preparation and approval of treatment plans, and to perform quality assurance of treatments. Tasks include image acquisition, viewing, manipulation, treatment plan definition, and scheduling.

Regulatory Classification

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

• Varis Images including Ximatron Digital Imaging option (K952313)
• Varis 1.4g (K001643)

Submission Summary (Full Text)

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KOH2954

# MAR 1 1 2005

### 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the Trilogy Radiotherapy Delivery System

# l. Submitter:

ﺳﮯ

Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] [phone] Fax: Email: vy.tran(@)varian.com Date summary was prepared: October 25, 2004

# 2. Name of the Device:

Vision Trade/Proprietary Name: Image Database Common or Usual Name: Radiological Image Processing System Classification Name: 21 CFR §892.5840 Class II Product Code: 90 LLZ

## 3. Predicate Devices:

- Varis Images including Ximatron Digital Imaging option, K952313 a.
- Varis 1.4g, K001643 b.

#### 4. Description of the Device:

The name Varis Images has changed to Vision. The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive plan and image data from diagnositic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

## 5. Intended Use Statement:

Vision is a plan and image management application that is intended to enable an authorized user to enter, access, modify, store and archive plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.

- Summary of the Technological Characteristics: The Substantial Equivalence 6. Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 9 of the submission.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

MAR 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc, 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K042956 Trade/Device Name: Vision™ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Product Code: 90 IYE Regulation Number: 21 CFR §892.5840 Regulation Name: Radiation therapy stimulation system Product Code: 90 KPQ Regulatory Class: II Dated: February 1, 2005 Received: February 3, 2005

Dear Ms. Tran:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the enclosure) to regally manufact of the Medical Device Amendments, or to devices that have been May 20, 1710, the classified in accordans of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the general registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your device is elassince (to such additional controls. Existing major regulations affecting your Apploval), It the 70 000 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that r case or action that be a cremination that your device complies with other requirements of the Act or any For has mass and regulations administered by other Federal agencies. You must comply with all the I cacal statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling ACL's requirements, morating but not as a set forth in the quality systems (QS) (21 CFR Part 80 73 god 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. THE FDA midnig of Subscannal or your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, "Thisotanany on your responsibilities under the Act from the 807.97). Tou may obtain other gollerer missional and Consumer Assistance at its toll-free number (800) DIVISIon of 311an Manufactures, Internet address http://www.fda.gov/cdrl/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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042957 510(k) Number (if known): Device Name: Vision

# Indications For Use:

Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

*Prescription Use*

David A. Lyon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________