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510(k) Data Aggregation
K Number
K223116Device Name
8X-10-6XXX Camera Head
Manufacturer
Date Cleared
2023-02-28
(148 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Santa Barbara Imaging Systems
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 8X-10-XXXX Camera System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The 8X-10-XXXX Camera System is indicated for use with a compatible 8X-10-XXXX Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.
Device Description
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K Number
K152513Device Name
8X-10-XXXX Camera System
Manufacturer
Date Cleared
2015-12-15
(104 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Santa Barbara Imaging Systems
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 8X-10-XXXX Camera System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The 8X-10-XXXX Camera System is indicated for use with a compatible 8X-10-XXXX Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.
Device Description
The 8X-10-XXXX Camera System is a high-definition camera used to capture still and video images of endoscopic or general surgications. The system also incorporates an optional internal light source featuring a Turret Light Guide Adapter which accepts various light guides. The 8X-10-XXXX Camera System consists of a console and a compatible 8X-10-XXXX camera head.
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