(28 days)
No
The summary describes standard PET/CT imaging technology and image reconstruction/fusion techniques, with no mention of AI or ML. The changes noted are hardware-related (water-cooled gantry, optional computer).
No
The device is described as an imaging and diagnostic tool, not one that provides therapy or treatment. Its purpose is to image and measure metabolic and physiologic functions and produce cross-sectional images for diagnostic imaging.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system allows for "single modality CT and / or PET diagnostic imaging," and the "Device Description" section reiterates this by stating it allows for "most standard stand-alone CT and PET clinical diagnostic protocols."
No
The device description clearly states it is a combined PET/CT scanner, which are hardware devices. While it includes computer reconstruction and image processing, these are functions of the hardware system, not a standalone software device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Siemens PET/CT scanners are used to image and measure the distribution of injected radiopharmaceuticals in humans and to produce cross-sectional images of the body using X-Ray transmission data. This involves imaging the patient directly, not analyzing samples taken from the patient.
- Intended Use: The intended use is for imaging and determining metabolic and physiologic functions within the human body, and producing images of the body.
The device is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
KPS and JAK
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT)
Anatomical Site
whole-body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
and Computed Tomography (CT) system |
|----------------------|---------------------------------------------------------------------------------------|
| Classification Name: | Emission Computed Tomography System per 21
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. | |
| Molecular Imaging | K060060 | |
| Biograph 64 and | ||
| Biograph 40 | Siemens Medical Solutions USA, Inc. | |
| 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: (865) 218-2000 www.siemens.com/medical
Page 13 of 490
1
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: (865) 218-2000 www.siemens.com/medical
2
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
3
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 (800) 638-2041 or (240) 276-3150
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
4
Indications for Use
510(k) Number (if known):
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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