Ophthalmic Imaging Systems - FDA 510(k) Cleared Devices
Recent clearances: OIS SYMPHONY IMAGE MANAGMENT SYSTEM, WINSTATION RETINAL IMAGER
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ophthalmic Imaging Systems Ophthalmic ✕
5 devices
Cleared
May 18, 2011
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
Ophthalmic
135d
Cleared
Nov 17, 2009
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
Ophthalmic
104d
Cleared
Oct 23, 1998
WINSTATION RETINAL IMAGER
Ophthalmic
81d
Cleared
Nov 27, 1991
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
Ophthalmic
85d
Cleared
Oct 09, 1991
GLAUCOMA-SCOPE
Ophthalmic
86d