SOMATOM FLASH DS

K082220 · Siemens Medical Solutions USA, Inc. · JAK · Oct 10, 2008 · Radiology

Device Facts

• Record ID: K082220
• Device Name: SOMATOM FLASH DS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Siemens SOMATOM P47 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. In addition the SOMATOM P47 is able to produce additional image planes and analysis results by executing optional postprocessing features, which operate on DICOM images. The images and results delivered by the system can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Story

Computed Tomography (CT) X-ray system; utilizes two continuously rotating tube-detector systems; operates on fan beam principle. Inputs: X-ray transmission data. Processing: computer reconstruction of data into cross-sectional images; optional postprocessing of DICOM images for additional planes/analysis. Outputs: DICOM-format CT images and analysis results. Used in clinical settings by trained physicians; aids in diagnostic decision-making. System includes command-based software for patient/data management, scan control, and image archiving.

Clinical Evidence

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

Technological Characteristics

Dual-source CT system; two continuously rotating tube-detector systems; fan beam geometry. Produces DICOM images. Software: SOMARIS/7 command-based program. Connectivity: supports postprocessing applications. Regulatory class II; product code JAK.

Indications for Use

Indicated for use by trained physicians to produce cross-sectional body images via computer reconstruction of X-ray transmission data (axial or spiral planes) to aid in diagnosis.

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 Definition AS/AS+ (K081022)
• Siemens SOMATOM Definition (K052216)

Submission Summary (Full Text)

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K082220

### OCT 1 0 2008

### SIEMENS

510(K) SUMMARY FOR SOMATOM P47

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

September 4, 2007

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:

Mrs. Corrine McLeod Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA

51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:[phone] Fax: [phone]

#### 2. Device Name and Classification

| Product Name: | SOMATOM P47 |
|-----------------------|----------------------------------|
| Propriety Trade Name: | SOMATOM Flash DS |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |

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# SIEMENS

#### 3. Substantial Equivalence:

Siemens SOMATOM P47 Computed Tomography X-ray system, configured with software SOMARIS/7 is substantially equivalent to the following medical device in commercial distribution:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|-----------------------------------|----------------------|--------------------|
| Siemens SOMATOM Definition AS/AS+ | K081022 | 06/05/2008 |
| Siemens SOMATOM Definition | K052216 | 09/08/2005 |

#### 4. Device Description:

The Siemens SOMATOM P47 is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The SOMATOM P47 system produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors.

The computer system delivered with the CT scanner is able to run such post processing applications optionally.

#### 5. Indications for Use:

The Siemens SOMATOM P47 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.

In addition the SOMATOM P47 is able to produce additional image planes and analysis results by executing optional postprocessing features, which operate on DICOM images.

The images and results delivered by the system can be used by a trained physician as an aid in diagnosis.

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

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# SIEMENS

#### 6. General Safety and Effectiveness Concerns:

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 during 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Ms. Corrine McLeod Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway E50 MALVERN PA 19355-1406

Re: K082220

Trade/Device Name: Somatom P47 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 1, 2008 Received: August 11, 2008

Dear Ms. McLeod:

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.

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### Page 2

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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Arqui M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indication for Use Statement

## SIEMENS

510(k) Number (if known): NO (22220

Product Name:

Somatom P47

### Indications for Use:

The Siemens SOMATOM P47 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.

In addition the SOMATOM P47 is able to produce additional image planes and analysis results by executing optional postprocessing features, which operate on DICOM images.

The images and results delivered by the system can be used by a trained physician as an aid in diagnosis.

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arun M Wang

Division of Reproductive. and Radiological De