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510(k) Data Aggregation
K Number
K233563Device Name
Navident
Manufacturer
ClaroNav Inc.
Date Cleared
2024-07-25
(262 days)
Product Code
PLV
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
ClaroNav Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K163439Device Name
NaviENT
Manufacturer
ClaroNav Inc.
Date Cleared
2017-09-01
(267 days)
Product Code
HAW, PGW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
ClaroNav Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).
NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.
Device Description
NaviENT is a cart-based, computerized, image-guided navigational system, operating as a combined package for performing guided ENT surgery.
Using pre-acquired CT scan of the sinus, NaviENT provides the surgeon (usually otolaryngologists) with easy-to-use real-time guidance during sinus surgery. The key function performed by NaviENT during navigation is visualization of the instrument tip relative to the surrounding anatomy. This visualization assists the surgeon in performing the surgery.
NaviENT consists of four main components:
1. NaviENT Cart
2. Tracking System
3. Laptop Computer
4. NaviENT Instruments
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K Number
K161406Device Name
Navident
Manufacturer
ClaroNav Inc.
Date Cleared
2016-09-08
(111 days)
Product Code
PLV
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
ClaroNav Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partial edentulism.
Device Description
Navident is a cart-based, computerized, image-guided dental navigational system, operating as a combined package for performing both pre-operative planning and guided implant insertion. Using preacquired CT scan of the jaw, Navident provides the dentist (usually a GP dentist, prosthodontist, periodontist or dental surgeon) with implantation planning and real-time guidance during dental implants insertion.
The guidance function of Navident is primarily provided using a visualization of the drill pose (tip location and shaft axis direction) relative to the desired pose of the implant, as planned on a preacquired CT image of the jaw. This visualization assists the dentist in implementing their implantation plan.
Navident consists of four main components:
- 1. A notebook computer positioned above the patient's chest. The Navident software running on the computer provides both planning and navigation functionalities.
- 2. A handpiece attachment. The attachment consists of a universal removable metal adapter, and a specially marked plastic part, named DrillTag, which latches on the adapter.
- 3. A customizable patient jaw attachment consisting of a moldable stent part, named NaviStent, and a matching specially marked plastic tag, named JawTag. NaviStent can be formed, customized and tested for fit directly on the patient's jaw or on a plaster model. The patient wears the NaviStent during the CT scan and again during the surgery. Navident is able to continuously register NaviStent's position during surgery with its appearance in the CT scan automatically.
- 4. An optical position sensor which detects high contrast patterns printed on the DrillTag and JawTag and constantly reports their relative positions to the Navident software.
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