BIOGRAPH 6

K060060 · Siemens Medical Solutions USA, Inc. · KPS · Feb 3, 2006 · Radiology

Device Facts

• Record ID: K060060
• Device Name: BIOGRAPH 6
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: Feb 3, 2006
• 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 plan 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.

Device Story

Biograph 6 is a combined PET/CT scanner; integrates Siemens LSO HiRez PET scanner and Siemens Somatom Emotion 6 CT. Inputs: positron-emitting radiopharmaceuticals (PET) and X-ray transmission data (CT). Operation: PET component uses CT data for attenuation correction and anatomical registration/fusion. Output: fused metabolic and anatomic cross-sectional images. Used in clinical settings by trained healthcare professionals (radiologists/technicians). System maintains independent PET and CT functionality for single-modality diagnostic protocols. Benefits: provides precise anatomical reference for metabolic data; enables comprehensive whole-body diagnostic imaging.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Combined PET/CT system. PET component: LSO (Lutetium Oxyorthosilicate) crystal-based detector. CT component: Spiral CT scanner. Connectivity: Integrated system for image fusion and attenuation correction. Software: Reconstruction algorithms for PET and CT data. Sterilization: Not applicable (imaging equipment).

Indications for Use

Indicated for humans requiring metabolic and physiologic imaging via positron emitting radiopharmaceuticals and cross-sectional anatomical imaging via X-ray CT. Used by trained healthcare professionals for oncology, neurology, and cardiology applications.

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

• LSO PET/CT HiRez Series (K050509)

Submission Summary (Full Text)

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Koboobo

2006 FEB 3

## 510(k) Summary

as required by 21 CFR Part 807.87(h)

Identification of the Submitter

| Submitter: | Alaine Medio, RAC |
|---------------------|-------------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Submission: | 1/6/05 |

Identification of the product

| Device Proprietary Name: | Biograph 6 |
|--------------------------|---------------------------------------------------------------------------------------|
| 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 |

Marketed Devices to which Equivalence is claimed

| Device | Manufacturer | 510(k) Number |
|-------------------------|-------------------------------------------------------------------------------------|---------------|
| LSO PET/CT HiRez Series | CTI PET Systems (now<br>Siemens Medical<br>Solutions USA Inc.<br>Molecular Imaging) | K050509 |

## Device Description:

The biograph 6 is a combined Positron Emission Tomography and X-Ray The blograph one a commensment. This system is designed for whole-body Computed Tomography ocannology examinations. The biograph 6 provides oncology, nearology and carafereiragy on and anatomic information registration and fasion of mgr. Foot and system, the Siemens LSO HiRez PET scanner and the Siemens Somatom Emotion 6 CT.

The combined PET/CT scanner is intended for use as a clinical, whole-body machine with high-end spiral CT and PET performance. The CT component

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provides 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, nllowing 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 (LSO PET/CT HiRez series scanner approved under the former CTI PET Systems Inc. name). The change incorporated in this application consists of a modification made to the detector mechanical configuration.

## 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:

- 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 plan 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.

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its wings. The bird is facing left. Surrounding the bird is text arranged in a circular pattern, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alaine Medio, RAC Regulatory Clinical Affairs Specialist 4 Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37932

Re: K060060

2008

FEB 3

Trade/Device Name: Biograph 6 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: January 6, 2005 Received: January 10, 2005

Dear Ms. Medio:

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 510(k) rms letter with and by a finding of substantial equivalence of your device to a legally prematicated 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 11 you desire spectre arres 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 cntitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 7) = 1 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.

Nancy C. Brigdon

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):

K Dboobo

bjograph 6 Device Name:

Indications for Use:

The Siemens PET/CT scanners are combined Positron Emission Tomography The Slements FETFOT ocannolo more of the biography (CT) scanners. The biograph 6 is (PET) and A-Ray Oomputed Tomography (CT) (CT) (PCT)
intended to be utilized by appropriately trained health care professionals to:

- Image and measure the distribution of injected positron emitting . mage and measure the diombation of the purpose of determining various radiopharmaccultions in humans for the particins within the human body; and
- metabolic (moreoulur) and projection of the body by computer reconstruction of X-. Froduce cross-sectional images of the same axial plan taken at different angles or spiral planes taken at different angles.

The biograph 6 PET/CT provides registration and fusion of high-resolution The blograph of ETOT provides rogist. Inc.
metabolic and anatomic information. The PET component utilizes the CT for fast hielabolic and anatomio imemation in the studies and precise anatomical reference for attendation concessor maps Additionally, the system maintains independent fused i ET and Of images: Additions, and of devices, allowing for single modality CT and / or PET diagnostic imaging.

Prescription Use × (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

(Division Sian-Off) Division of Reproductive, Ab and Radiological Devices Page 1 of 1 510(k) Number __

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