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510(k) Data Aggregation
K Number
K243053Device Name
Navient Image Guided Navigation System (ENT) (955-NC-NC)
Manufacturer
ClaroNav
Date Cleared
2025-06-20
(266 days)
Product Code
PGW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
ClaroNav
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures. The Navient system 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 a CT, MR-based anatomy model.
Indications:
Example procedures include but are not limited to:
ENT Procedures:
- Transsphenoidal procedures
- Maxillary antrostomies
- Ethmoidectomies
- sphenoidotomies
- Sphenoid explorations
- Turbinate resections
- Frontal sinusotomies
- Intranasal procedures
- Intranasal tumor resections
- All ENT related skull base surgery
Device Description
Navient is an image guided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via optical tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory set.
Navient's guidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.
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K Number
K241327Device Name
Navient Image Guide Navigation System (955-NC-NC), Cranial
Manufacturer
ClaroNav
Date Cleared
2025-02-05
(271 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
ClaroNav
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.
The Navient system 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 a CT, MR based model of the anatomy.
Indications:
Example procedures include but are not limited to:
- Cranial Procedures:
- Tumor resections
- · Cranial biopsies
- · Craniotomies
- · Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
Device Description
Navient is an image quided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via (infrared) tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory sets intended for specific clinical applications.
Navient's quidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.
Depending on the desired clinical application, the Navient system also includes the following instrument/accessory kits. These reusable instruments are intended to be sterilized/disinfected prior to use.
- Cranial Accessory Kit (955-NC-AKC) o
- Biopsy Accessory Kit (955-NC-AKB) O
Disposable tracker instruments are also available based on user preference.
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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
K210947Device Name
Navident
Manufacturer
ClaroNav Inc
Date Cleared
2022-06-27
(454 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 partially or fully edentulous jaws.
Device Description
Navident is an image-guided dental navigational system intended to assist with preoperative planning and real-time positioning of drilling tools during implantation surgery. In particular, Navident provides visual, real-time feedback on the location of the working tip of a dental handpiece. It shows the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image. Navident is comprised of the following parts: The main system is comprised of a cart that carries a stereoscopic video camera and a laptop with pre-installed proprietary software. The Navident system also includes several types of accessories: Jaw motion Tracking Accessories, Dental Handpiece Tracking Accessories, Registration accessories, Calibrator. Navident's four core functions are: Model, Plan, Register, Guide.
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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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