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510(k) Data Aggregation
K Number
K041780Device Name
NEW BRID
Manufacturer
Date Cleared
2004-08-11
(41 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL IMAGING SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures (such as PTCA, stent placement, atherectomies), pacemaker implantations, and electrophysiology. It may also be used for other imaging applications at the physician's discretion.
Device Description
The MIS NewBrid System is the result of integrating new and or refurbished/rebuilt positioners. components and digital imaging systems that are previously cleared by the FDA. Some of the new components will change the original manufacturers specifications and functionality. For example, MIS could remove the original manufacturers Image Intensifier-based imaging chain and replace it with new components or with a solid-state flat panel detector. MIS will integrate its own system interface rack for system control. The image acquisition package with a system purchased from an OEM that has 510[k] approval. The pivoting base will allow for an extend area of patient imaging coverage.
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