SOMATOM EMOTION 16

K050297 · Siemens Medical Solution, Inc. USA · JAK · Mar 1, 2005 · Radiology

Device Facts

• Record ID: K050297
• Device Name: SOMATOM EMOTION 16
• Applicant: Siemens Medical Solution, Inc. USA
• Product Code: JAK · Radiology
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The SOMATOM Emotion 16 is 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 Emotion 16 is a 16-slice whole-body X-ray computed tomography (CT) system. It utilizes a continuously rotating X-ray tube and detector array operating on the fan beam principle to acquire transmission data. The system performs computer reconstruction of this data to generate cross-sectional images of the body from axial or spiral planes. Operated by trained clinical staff in a radiology setting, the device uses the syngo-based Somaris/5 software for patient management, scan control, image reconstruction, and archiving. The output images are reviewed by physicians to assist in clinical diagnosis and decision-making. The system benefits patients by providing detailed internal anatomical visualization for diagnostic purposes.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by hazard analysis, software verification, and validation testing, adhering to established industry practices and standards for electrical, mechanical, and radiation safety.

Technological Characteristics

16-slice whole-body CT system; fan beam geometry; continuously rotating X-ray tube and detector assembly; syngo-based Somaris/5 software (version VB28); connectivity for image archive/evaluation; complies with radiation safety standards.

Indications for Use

Indicated for whole-body diagnostic imaging via cross-sectional X-ray computed tomography reconstruction in patients requiring clinical evaluation of internal structures.

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 Emotion 6 (K023687)

Submission Summary (Full Text)

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### 510(K) SUMMARY FOR SOMATOM PROJECT P10G

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

February 4, 2005

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.

#### 1. Contact Person:

14

Ms. Debra Peacock Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA

51 Valley Stream Parkway E-50 Malvern, PA 19355 Phone: [phone] Fax: [phone]

Koso29

#### 2. Device Name and Classification

| Product Name: | SOMATOM Emotion 16 |
|-----------------------|----------------------------|
| Classification Name: | Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
| | |

#### 3. Substantial Equivalence:

Siemens SOMATOM P10G Computed Tomography X-ray systems, configured with software version SOMARIS/5 is substantially equivalent to the following medical device in commercial distribution:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---------------------------|----------------------|--------------------|
| Siemens SOMATOM Emotion 6 | K023687 | 11/22/2002 |

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#### Device Description: 4.

The Siemens SOMATOM Emotion 16 system is a 16 slice, whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The software is syngo-based Somaris/5 software version VB28, which is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

#### Indications for Use: ડ.

The SOMATOM Emotion 16 is 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 angels 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. )

#### 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 potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers. The overall design is simple and conveys a sense of official government branding.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 - 2005

Ms. Debra Peacock Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355

Re: K050297 Trade/Device Name: SOMATOM Project P10G (SOMATOM Emotion 16) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 4, 2005 Received: February 9, 2005

Dear Ms. Peacock:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have revewed your section 510(t) prehestantially equivalent (for the indications for use stated in above and nave decemined the ac needicate devices marketed in interstate commerce prior to the enclosure) to regary maneled problements, or to device Amendments, or to devices that have been May 26, 1970, the chaculient date of the Federal Food, Drug, and Cosmetic Act (Act) that fectassified in accordatics with the pro horena al application (PMA). You may, therefore, market the do not require approval on a promation approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provided to the severes, 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 If your device is classified (see as re) additional controls. Existing major regulations affecting your Apploval), it thay be subject to cash aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round in the courseming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I reast of advised mar 1127 is issual 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 receial statues and regulation. administer to registration and listing (21 CFR Part 807); labeling Act STEQuirements, moducing, but no a practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the clectronic 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) This letter will allow you to begin hanceling of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale vour dev premarket notification. The PDA midnig of saosantal organical organits 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 labeling regulation (
contact the Office of Compliance at one 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 premarket notification" (21 CFR A lso, please note the regulation chilited, "frisonalians of your responsibilities under the Act from the (8) 807.97). You may obtain other general information on your bely and its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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## SECTION 3 INDICATION FOR USE

510(k) Number (if known):

Ko 50297

Device Name:

# SOMATOM Project P10G (SOMATOM Emotion 16)

The Siemens SOMATOM Emotion 16 system is 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.)

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

Prescription Use i

(Per 21 CFR §801.109)

OR Over-The-Counter Use

David W. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices KOSO24 510(k) Number _

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