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510(k) Data Aggregation
K Number
K231133Device Name
neo315
Manufacturer
Date Cleared
2024-07-22
(458 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Neoscan Solution GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The neo315 is a magnetic resonance diagnostic device which 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 resonance. Other physical parameters derived from the images and/or spectra may also be produced.
The device includes hydrogen-1 (proton) imaging, hydrogen-1 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). The intended group of patients for the neo315 can be found in the pediatric environment. The exclusion of patients is determined by the dimensions of the patient bed and excludes patients that exceed a 120 cm length and a diameter of 26 cm. The weight of the patient shall not exceed 18 kg.
Device Description
The neo315 is a conductively cooled 1.5T whole body magnetic resonance diagnostic device (MRDD) which generates images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Its intended group of patients for the neo315 can be found in the pediatric environment. The neo315 consists of the Field Generating Unit (FGU), two technical cabinets (consoles) and gets operated via the operating software ScanUI.
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