(25 days)
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.
The biograph 6 is a combined Positron Emission Tomography and X-Ray Computed Tomography system. This system is designed for whole-body examinations. The biograph 6 provides oncology, neurology and cardiology information and anatomic information registration and fusion. The system is comprised of two components, 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 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 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.
The provided text is a 510(k) summary for the Biograph 6 PET/CT system. It does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. The document focuses on device description, indications for use, and a declaration of substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
The information you've asked for (acceptance criteria, device performance table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment, training set size) is typically found in performance studies or validation reports, which are not present in this 510(k) summary.
§ 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.