ENT Software

ENT Software
Scopis - 8000-021-001

An application software program intended to facilitate stereotactic treatment procedures (surgery or radiosurgery) by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, real-time surgical navigation and/or patient/procedure data management, image processing/transfer, and quality assurance. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PGW

Device Name: Ear, Nose, And Throat Stereotaxic Instrument

Device Class: 2

Physical State: Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer.

Definition: Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

Submission Type ID: 1

Review Panel: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Ear, nose and throat

Regulation Number: 882.4560

Third Party Flag: N

Medical Specialty: NE

Device Id: 07613327513943

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A