Address:3600 Clipper Mill Rd Ste 400,Baltimore,MD,21211,US
Device Description : The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
Device Class :
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
Device Class :
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
Device Class :
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
Device Class :
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
Device Class : 2
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
Device Class :
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 965399905
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is a sterile accessory intended to provide a sterile barrier for medi The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
Device Class : 2
Duns Number: 965399905
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The device is a sterile accessory intended to provide a sterile barrier for medi The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet.
Device Class :
Duns Number: 965399905
Premarket Exempt : Yes
Prescription Use : Yes