The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 64 and 40 are 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 64 and 40 PET/CTs provide 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 Description

The Biograph 64 and Biograph 40 are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology examinations. The Biograph systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the Siemens LSO HiRez PET scanner and the Siemens Somatom Sensation 64 or 40 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 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, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

AI/ML Overview

The provided text is a 510(k) summary for the Biograph 64 and Biograph 40 PET/CT systems. It describes the devices, their indications for use, and claims substantial equivalence to previously cleared devices.

Based on the content, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert involvement, adjudication methods, or ground truth establishment. The document is primarily a regulatory submission for premarket notification, focusing on equivalence to existing devices rather than a detailed performance study against defined acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions about standalone performance, MRMC studies, sample sizes, or ground truth establishment for a performance study. This type of information is typically found in detailed validation reports, not in a 510(k) summary.

Summary

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K06D63!

MAR 1 7 2006

510(k) Summary

as required by 21 CFR Part 807.87(h)

Identification of the Submitter

Submitter:	Alaine Medio, RAC
Telephone Number:	(865)218-2703
Fax Number:	(865)218-3019
Date of Submission:	2/10/06

ldentification of the product

Device Proprietary Name:	Biograph 64 and Biograph 40
Common Name:	Combination Positron Emission Tomography (PET)and Computed Tomography (CT) system
Classification Name:	Emission Computed Tomography System per 21CFR 892.1200Computed Tomography X-Ray System per 21 CFR892.1750

Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
Biograph 6	Siemens MedicalSystems USA Inc.	K060060
LSO PET/CT HiRez Series	CTI PET Systems (nowSiemens MedicalSolutions USA Inc.)	K050509
Somatom Project P30F	Siemens MedicalSystems USA Inc.	K040665

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Device Description:

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 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, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

The Biograph 64 and Biograph 40 systems which are the subject of this application are substantially equivalent to the commercially available Biograph 6 PET/CT system (K060060) and the Siemens Somatom Project P30F CT system (K040665).

Indications for Use:

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 64 and 40 PET/CTs provide 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAR 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solutions USA, Inc. % Mr. Daniel Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K060631

Trade/Device Name: Biograph 64 and Biograph 40 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: March 8, 2006 Received: March 9, 2006

Dear Mr. Lehtonen:

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) 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.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 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/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):

K060631

Biograph 64 and Biograph 40 Device Name:

Indications for Use:

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.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Bragdon

(Division Sign-Off Division of Reproductive, Abd and Radiological Devices 510(k) Number

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Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
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.(b)
Classification. Class II.