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Found 3 results
510(k) Data Aggregation
K Number
K970586Device Name
BRAINLAB MICRO MULTI-LEAF COLLIMATORManufacturer
Date Cleared
1997-05-12
(87 days)
Product Code
Regulation Number
892.5050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
BRAINLAB MED. COMPUTERSYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K954861Device Name
BRAINLAB CT/X-RAY LOCALIZERManufacturer
Date Cleared
1996-08-05
(287 days)
Product Code
Regulation Number
892.5050Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
BRAINLAB MED. COMPUTERSYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K952390Device Name
BRAINLAB STEROTATIC HEADRINGManufacturer
Date Cleared
1996-02-02
(256 days)
Product Code
Regulation Number
882.4560Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
BRAINLAB MED. COMPUTERSYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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