Search Results

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 family systems 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 updates to the Biograph mCT systems which are the subject of this application are considered substantially equivalent to the commercially available Biograph mCT software. Major modifications to the family of systems include:

• Updated 510(k) cleared CT. is used compared to the CT used in the predicate PET/CT system . (K113448);
• · Updated gantry control buttons, and patient call button;
• Updated computer hardware;
• Updated software including:
  • updated operating system; 0
  • additional user configurable options and workflows
  • cardiac gating updates to provide for improved gating characteristics :; o
  • updated workflows for ease of use; and ಂ
  • improvements in image quality. o

The new Biograph mCT capitalizes on list mode acquisition and positional information. Combined with the latest generation computer electronics it enables to continually take counts and reconstruct image data, providing a real-time display of the data flow as reconstructed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biograph mCT Family of PET/CT Systems:

1. Table of Acceptance Criteria and Reported Device Performance

/= 8.5 cps/kBq (4R) | Pass |
| Count Rate peak NECR | 86 kcps @ 36 kBq/cc (3R)
140 kcps@25 kBq/cc (4R) | Pass |
| Count Rate peak trues | 280 kcps @ 42 kBq/cc (3R)
450 kcps @ 42 kBq/cc (4R)| Pass |
| Count Rate bias (mean) |

Ask a specific question about this device