(79 days)
The BOLD MRI Package for MAGNETOM VISION and SYMPHONY MR systems, provides dedicated acquisition and reconstruction techniques which offer the possibility of visualization of small susceptibility changes, due to increased levels of oxygen, by parametric images. The parametric images provide parameter information, instead of anatomical information. These parametric images can be overlaid on the anatomical images to optimize the presentation of information to support the diagnostic process. These BOLD images when interpreted by a trained physician, yield information that may assist in diagnosis.
The BOLD MRI Package is an postprocessing option for the MAGNETOM VISION and MAGNETOM SYMPHONY Systems
The provided text, a 510(k) summary for the BOLD MRI Package, does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on:
- General Information: Establishment details, contact person, date of summary, device name, classification.
- Device Description: The BOLD MRI Package is a postprocessing option for MAGNETOM VISION and SYMPHONY Systems.
- Intended Use: Visualization of small susceptibility changes due to increased oxygen levels via parametric images, which can be overlaid on anatomical images to assist diagnostic processes when interpreted by a trained physician.
- Technological Characteristics: Substantially equivalent magnet, RF, and gradient systems to standard MAGNETOM VISION and SYMPHONY systems.
- Safety and Effectiveness Concerns: States that operation is "substantially equivalent" and MR safety and performance parameters are "unaffected by the modification." It lists several safety and performance aspects (Maximum Static Field, RF Power Deposition, Signal to Noise, Image Uniformity, etc.) that are supposedly unchanged.
- Substantial Equivalence Claim: Mentions that "Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness," but no details of these tests are provided.
- FDA Communication: A letter from the FDA confirming receipt of the 510(k) and determining substantial equivalence.
- Indications for Use: Reiterates the intended use.
Therefore, I cannot populate the requested table and sections as the input text does not include the necessary information. The document explicitly states that laboratory and clinical testing were performed to support the claim of substantial equivalence, but it does not describe the methods, results, or acceptance criteria of these studies.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.