Medical Device Manufacturer · US , Atlanta , GA

Image Systems, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1985

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Image Systems, Inc. Radiology ✕

3 devices

1-3 of 3

Cleared Nov 19, 1991

Radiology · 90d

Cleared Aug 21, 1990

SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF

Radiology · 148d

Cleared Feb 27, 1985

INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM

Radiology · 82d