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510(k) Data Aggregation
K Number
K181706Device Name
neuromate Gen III
Manufacturer
Date Cleared
2018-07-26
(28 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Renishaw Mayfield Sarl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the following stereotactic frames:
- 1 the Leksell Type G comprising of head frame and CT Localizer,
- 2 the CRW HRAIM with the BRWLF localizer.
- 3 the CRW UCHRA with the Luminant and BRWLF localizers
Device Description
Not Found
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K Number
K180206Device Name
neuromate Gen III
Manufacturer
Date Cleared
2018-04-24
(90 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Renishaw Mayfield Sarl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
neuromate Gen III has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer).
Device Description
A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool-guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
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K Number
K132755Device Name
NEUROMATE FRAMELESS GEN II
Manufacturer
Date Cleared
2014-04-29
(238 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
RENISHAW MAYFIELD SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
Device Description
A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.
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