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Found 4 results
510(k) Data Aggregation
K Number
K090785Device Name
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
Manufacturer
INVIVO CORP.
Date Cleared
2009-12-15
(267 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
INVIVO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Expression MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.
Device Description
The Expression MRI Patient Monitoring System (Model 865214) is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving magnetic resonance (MR) environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MR environment. The Expression MRI Patient Monitoring System (Model 865214) includes monitoring capabilities for wireless electrocardiogram (ECG), wireless pulse oximetry (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, respiration, end-tidal CO2 (EtCO2), oxygen, and anesthetic agents.
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K Number
K052704Device Name
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
Manufacturer
INVIVO CORP.
Date Cleared
2005-11-03
(36 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
INVIVO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
Device Description
Model BBD Breast Immobilization and Biopsy Device
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K Number
K052497Device Name
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
Manufacturer
INVIVO CORP.
Date Cleared
2005-10-12
(30 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
INVIVO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck that can be interpreted by a trained physician.
Device Description
Model NVA-127-16-A Neurovascular Array Coil
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K Number
K051512Device Name
CAC-127-8 CARDOAC ARRAY COIL
Manufacturer
INVIVO CORP.
Date Cleared
2005-06-28
(21 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
INVIVO CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician.
Device Description
Model CAC-127-8 Cardiac Array Coil
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