SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION

K032536 · Siemens Medical Solutions USA, Inc. · JAK · Nov 10, 2003 · Radiology

Device Facts

• Record ID: K032536
• Device Name: SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 10, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Extended Field of View is part of the software module within the CT operating system and provides the selection and image reconstruction variable up to a fixed limit. As an option the limit has been extended up to 70 cm and the use of this special application requires a license key.

Device Story

Extended Field of View (FoV) is a software module for Siemens CT systems; enables selection and reconstruction of images with variable targets; extends maximum visualization limit to 70 cm; utilizes data extrapolation and Fast Fourier Transformation (FFT) for reconstruction; requires license key for activation; operated by radiology staff within the CT operating system; provides clinicians with expanded anatomical visualization for diagnostic imaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based CT image reconstruction module; utilizes data extrapolation and Fast Fourier Transformation (FFT) algorithms; extends field of view to 70 cm; requires license key for operation; integrated into existing Siemens CT operating system software.

Indications for Use

Indicated for use as a software option for CT systems to enable image reconstruction and visualization with an extended field of view up to 70 cm.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Siemens SOMATOM Project 10 Emotion 6 (K023687)
• Siemens SOMATOM Project 30 Sensation 16 (K013522)

Submission Summary (Full Text)

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Page 1 of 2

NOV 1 0 2003

K032536

# FOR THE EXTENDED FIELD OF VIEW SOFTWARE OPTION

Submitted by:

Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355

August 14, 2003

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

- Contact Person: 1.
Ms. Nealie Hartman Phone: [phone] Fax: [phone]

# 2. Device Name and Classification

Product Name: Common Name Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

Extended Field of View (FoV) Software Package 3D CT Reconstruction Software Accessory to Computed Tomography System Radiology 21 CFR §892.1750 Class II 90 JAK

## Importer/Distributor Establishment: 3.

Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355

# Manufacturing Facility: 4.

Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany

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KC32534

# ડ. Substantial Equivalence

The Extended Field of View (FoV) software package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|--------------------------------------------|----------------------|--------------------|
| Siemens SOMATOM Project 10<br>Emotion 6 | K023687 | 11/22/02 |
| Siemens SOMATOM Project 30<br>Sensation 16 | K013522 | 11/07/01 |

### 6. Device Description

Extended Field of View is software package, which supports the selection and image reconstruction with variable targets. The maximum of visualization has been extended to the length of 70 cm2. Due to the extrapolation of the reconstructed data and the convolution with a suitable Fast Fourier Transformation this software package allows the desired extended Field of View (FoV).

#### 7. Intended Use

Extended Field of View is part of the software module within the CT operating system and provides the selection and image reconstruction variable up to a fixed limit.

As an option the limit has been extended up to 70 cm and the use of this special application requires a license key.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, with three flowing lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2003

Ms. Nealie Hartman Technical Specialist Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K032536 Trade/Device Name: Somatom Extended Field of View Software Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II

Product Code: 90 JAK Dated: August 14, 2003 Received: August 18, 2003

Dear Ms. Hartman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions 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 device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code 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 FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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510(k) Number (if known): Extended Field of View Software Application Device Name:

Extended Field of View is part of the software module within the CT operating system and provides the selection and image reconstruction variable up to a fixed limit. As an option the limit has been extended up to 70 cm and the use of this special application requires a license key.

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR §801.109) OR Over-The-Counter Use

Nancy L. Bragdon

(Division Sign Off Division of Reproductive, Abdon and Radiological Devic 510(k) Number