FDA.reportPublic FDA data

Optical surgical navigation device tracking system

Definition
A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].
GUDID devices
13
Last updated
2024-03-20 07:07:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
17290019120336PathKeeper Surgical Accessories KitPATHKEEPER SURGICAL LTDKIT00022024-03-12
17290019120343PKS Patient Reference DRFPATHKEEPER SURGICAL LTDMAS00022024-03-12
17290019120350PKS DRF 2 - ID 5.9PATHKEEPER SURGICAL LTDMAS00032024-03-12
17290019120367PKS DRF 4 - ID 7.9PATHKEEPER SURGICAL LTDMAS00052024-03-12
17290019120374PKS DRF 3 - ID 12.2PATHKEEPER SURGICAL LTDMAS00072024-03-12
17290019120183PKS Accessories Setup DRFPATHKEEPER SURGICAL LTDMAS00012023-11-20
17290019120206PKS Patient Reference DRFPATHKEEPER SURGICAL LTDMAS00022023-11-20
17290019120220PKS DRF 2-ID5.9PATHKEEPER SURGICAL LTDMAS00032023-11-20
17290019120244PKS DRF 2-ID6.9PATHKEEPER SURGICAL LTDMAS00042023-11-20
17290019120268PKS DRF 4-ID7.9PATHKEEPER SURGICAL LTDMAS00052023-11-20
17290019120282PKS DRF 4-ID9.5x8PATHKEEPER SURGICAL LTDMAS00062023-11-20
17290019120305PKS DRF 3-ID12.2PATHKEEPER SURGICAL LTDMAS00072023-11-20
17290019120329PKS DRF 3-ID15PATHKEEPER SURGICAL LTDMAS00082023-11-20