IZS — Aperture, Radiographic Class II

FDA Device Classification

FDA product code IZS covers "Aperture, Radiographic", a Class II medical device regulated under 21 CFR 892.1610. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
IZS
Device Class
Class II
Regulation Number
892.1610
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K895084custom medical productsAPERTUREOctober 27, 1989