SOMATOM DEFINITION

K052216 · Siemens Medical Systems, Inc. · JAK · Sep 8, 2005 · Radiology

Device Facts

• Record ID: K052216
• Device Name: SOMATOM DEFINITION
• Applicant: Siemens Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Sep 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Siemens SOMATOM P45 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Story

The SOMATOM P45 is a whole-body X-ray computed tomography (CT) system. It utilizes a continuously rotating X-ray tube and detector array to acquire transmission data while the patient is translated through the gantry. The system includes a command-based program for patient management, scan control, image reconstruction, and archiving/evaluation. Operated by trained clinical staff in a radiology setting, the device transforms raw X-ray data into cross-sectional images. These images are reviewed by physicians to assist in clinical decision-making and diagnosis. The device benefits patients by providing non-invasive, detailed anatomical imaging.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by hazard analysis, software verification, and adherence to recognized industry standards for CT systems.

Technological Characteristics

Whole-body X-ray CT system; utilizes continuously rotating X-ray tube and detector array; command-based software for scan control, image reconstruction, and data management. Operates via computer reconstruction of X-ray transmission data from axial or spiral planes.

Indications for Use

Indicated for producing cross-sectional body images via computer reconstruction of X-ray transmission data from axial or spiral planes. Intended for prescription use.

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 Sensation 64 (K013522)
• GE LightSpeed VCT (K040372)

Submission Summary (Full Text)

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# 510(K) SUMMARY FOR SOMATOM PROJECT P45

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

August 3, 2005

This summary of 510(k) safety and effectiveness information is being submitted in accordance with
er and experience of the 1902 - 191 CFF \$907 02 This Summary of STO(It) 82007.92.

#### Contact Person: 1.

Mr. Gary Johnson Mr. Gary Johnson
Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:[phone] Fax: [phone]

### Device Name and Classification 2.

| Product Name: | SOMATOM Project P45 |
|-----------------------|----------------------------|
| Classification Name: | Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |

#### Substantial Equivalence: 3.

Siemens SOMATOM P45 Computed Tomography X-ray systems, configured with Stemens SOMATOM 1 45 Computed Trineg of 19 11 5 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1 in commercial distribution:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|------------------------------|----------------------|--------------------|
| Siemens SOMATOM Sensation 64 | K013522 | 11/07/2001 |
| GE LightSpeed VCT | K040372 | 03/01/2004 |

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#### Device Description: 4.

The Siemens SOMATOM P45 is a whole body X-ray computed tomography system, which I he Slement SOMATON 1-19-15 a wills and functions and functions according to the fan assisted teatures two continuously routing is a command-based program used for paint management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

#### Indications for Use: 5.

The SOMATOM P45 is intended to produce cross-sectional images of the body by The SOMA TOM 145 13 medical vary ... at different angels or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulting from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)

## General Safety and Effectiveness Concerns: 6.

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify price a hazards. These potential hazards are controlled via software development, verification and nazards. These polchian hazaroo are concerners and radiation hazards, Siemens valuation woulding.
adheres to recognized and established industry practice and standards.

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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Systems USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K052216

SEP - 8 2005

Trade/Device Name: SOMATOM Project P45 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II

Product Code: JAK Dated: August 3, 2005 Received: August 3, 2005

Dear Mr. Johnson:

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, 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 Approval), 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 5 10(k) I his letter will anow you to begin hankemig your antial equivalence of your device to a legally premarket nothication. The PDA Intention of Saccament of 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 of the following 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 prematic notification" (21 CFR Also, please note the regulation entired, "Thisoranians on your responsibilities under the Act from the 180 807.97). You may obtain other general mieridance and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Nancy C. Hogdon

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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# SECTION 3 INDICATION FOR USE

510(k) Number (if known):

Device Name:

SOMATOM Project P45

KOSZZIK

The Siemens SOMATOM P45 systems are intended to produce cross-sectional images of the I he Slediens SOMATON 1-15 670012 x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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

| Prescription Use<br>(Per 21 CFR §801.109) | <div style="display:inline-block;"><span> <svg height="15px" width="15px"> <rect fill="none" height="15px" stroke="black" width="15px" x="0" y="0"></rect> <path d="M2,2 L13,13 M2,13 L13,2" stroke="black"></path> </svg> </span></div> | OR | Over-The-Counter Use | <div style="display:inline-block;"><span> <svg height="15px" width="15px"> <rect fill="none" height="15px" stroke="black" width="15px" x="0" y="0"></rect> </svg> </span></div> |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Division Sign-Off) | Nancy Brogdon | | | |
| Division of Reproductive, Abdominal,<br>and Radiological Devices | | | | |
| 510(k) Number | k052216 | | | |