Search Results
Found 1 results
510(k) Data Aggregation
K Number
K033621Device Name
NDI PASSIVE SPHERES
Manufacturer
NORTHERN DIGITAL, INC.
Date Cleared
2004-01-27
(70 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
NORTHERN DIGITAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate, and where a reference to a rigid anatomical structure can be identified relative to a CT or MRbased model of the anatomy.
Device Description
Not Found
Ask a Question
Page 1 of 1