BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197

K071068 · Siemens Medical Solutions USA, Inc. · KPS · May 14, 2007 · Radiology

Device Facts

• Record ID: K071068
• Device Name: BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: May 14, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 6 is intended to be utilized by appropriately trained health care professionals to: - Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and - 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. The Biograph 6 TruePoint PET/CT provides registration and fusion of highresolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

Device Story

Combined PET/CT scanner; utilizes LSO PET detector and Somatom Emotion 6 CT scanner. Inputs: positron-emitting radiopharmaceuticals (PET) and X-ray transmission data (CT). Operation: CT data provides attenuation correction maps for PET and anatomical reference for image fusion. Output: registered/fused metabolic and anatomic cross-sectional images. Used in clinical settings by trained healthcare professionals. System maintains independent PET and CT functionality for single-modality diagnostics. Output enables clinicians to visualize metabolic distribution and anatomical structures, facilitating diagnostic decision-making in oncology, neurology, and cardiology.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Combined PET/CT system; LSO PET scanner; Somatom Emotion 6 CT scanner; water-cooled gantry; computer-based image reconstruction; supports fused metabolic and anatomic imaging; independent modality operation.

Indications for Use

Indicated for humans undergoing whole-body oncology, neurology, or cardiology examinations requiring metabolic/physiologic imaging via radiopharmaceuticals and/or cross-sectional anatomical imaging via CT.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Biograph 6 (K060060)
• Biograph 64 (K060631)
• Biograph 40 (K060631)

Submission Summary (Full Text)

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K07/068

# SIEMENS

### 510(k) Summary as required by 21 CFR Part 807.92

MAY 1 4 2007

### Identification of the Submitter:

| Submitter: | Cristin Wetherbee |
|---------------------|-------------------|
| Telephone Number: | 865.218.2343 |
| Fax Number: | 865.218.3019 |
| Date of Submission: | 13 April 2007 |

#### Identification of the Product:

Device Proprietary Name: Biograph 6 TruePoint

| Common Name: | Combination Positron Emission Tomography (PET)<br>and Computed Tomography (CT) system |
|----------------------|---------------------------------------------------------------------------------------|
| Classification Name: | Emission Computed Tomography System per 21<br>CFR 892.1200, Computed Tomography X-Ray |

System per 21 CFR 892.1750

### Marketed Devices to which Equivalence is Claimed:

| Device: | Manufacturer: | 510(k) Number: |
|--------------------------------|----------------------------------------------------------|----------------|
| Biograph 6 | Siemens Medical Solutions USA, Inc.<br>Molecular Imaging | K060060 |
| Biograph 64 and<br>Biograph 40 | Siemens Medical Solutions USA, Inc.<br>Molecular Imaging | K060631 |

#### Device Description:

The Biograph 6 TruePoint scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology, and cardiology examinations. They provide registration and fusion of high-resolution metabolic and anatomic

### Siemens Medical Solutions USA, Inc.

Molecular Imaging

810 Innovation Drive Knoxville, TN 37932-2751 Tel: [phone] www.siemens.com/medical

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# SIEMENS

information from the two major components of each system, the Siemens LSO PET scanner and the Siemens Somatom Emotion 6 CT.

The combined PET/CT scanner is intended for use as a clinical, whole-body oncology machine with high-end spiral CT and PET performance. The CT component provides fast attenuation correction for PET studies as well as precise anatomical reference through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

The Biograph 6 system which is the subject of this application is substantially equivalent to the commercially available Biograph 6 (K060060) and the commercially available Biograph 64 and Biograph 40 (K060631). The notable changes incorporated in this application consist of the addition of a water-cooled gantry option and an optional computer.

### Indications for Use:

The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 6 is intended to be utilized by appropriately trained health care professionals to:

- o Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
- o 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.

The Biograph 6 TruePoint PET/CT provides registration and fusion of highresolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

### Siemens Medical Solutions USA, Inc.

Molecular Imaging

810 Innovation Drive Knoxville, TN 37932-2751 Tel: [phone] www.siemens.com/medical

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Cristin Wetherbee Regulatory Technology Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37932

MAY 1 4 2007

Re: K071068

Trade/Device Name: Biograph 6 TruePoint Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: April 13, 2007 Received: April 16, 2007

### Dear Mr. Wetherbee:

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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the logo.

Protecting and Promoting Public Health

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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). 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/cdrl/industry/support/index.html.

Sincerely 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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## Indications for Use

510(k) Number (if known):

K071068

Device Name: Biograph 6 TruePoint

Indications for Use:

The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 6 is intended to be utilized by appropriately trained health care professionals to:

- o Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
- Produce cross-sectional images of the body by computer reconstruction of o XRay transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

The Biograph 6 PET/CT provides registration and fusion of high-resolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

Prescription Use X (Part 21 CFR 801 Subpart D) Over the Counter Use (21 CFR 801 Subpart C)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

on of Reproduct

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