(45 days)
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces 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 PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
The Biograph mCT and mCT Flow PET/CT Scanners are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph mCT software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The software for the Biograph mCT systems which is the subject of this application is substantially equivalent to the commercially available Biograph mCT software. Modifications include:
- Syngo software upgrade
- Somaris Software (cleared in K143400, K143401))
- Twin beam scanning feature for Biograph mCT-X and Biograph mCT Edge
- HD Field of View Pro
- Iterative Metal Artifact Reduction (iMAR)
- Temporal minimum intensity projection and temporal maximum intensity projections (tMIP)
- FAST 3D align / 3D Reconstruction
- FAST DE Results
- Repiratory Online mode
- Enhancements to the Iterative Reconstruction software (ADMIRE)
- PETsyngo software
Here's an analysis of the provided text regarding the acceptance criteria and study for the Biograph mCT and mCT Flow PET/CT Scanners, based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table summarizing performance criteria and results based on NEMA NU2:2012 testing for the PET subsystem.
| Performance Criteria (Standard) | Reported Device Performance | Acceptance Criteria (from document) |
|---|---|---|
| Transverse Resolution FWHM @ 1 cm | Pass | = 5.0 cps/kBq (3R) |
= 9.4 cps/kBq (4R) |
| Count Rate peak NECR | Pass | >= 95 kcps @ 30 kBq/cc (3R)
= 165 kcps @ 28 kBq/cc (4R) |
| Count Rate peak trues | Pass | >= 350 kcps @ 46 kBq/cc (3R)
= 575 kcps @ 40 kBq/cc (4R) |
| Count Rate bias (mean) | Pass |
§ 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.