Medical Device Manufacturer · US , Fort Collins , CO

Otsuka Electronics USA, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1994

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Otsuka Electronics USA, Inc. Radiology ✕

2 devices

1-2 of 2

Cleared Sep 30, 1994

ORACLE MRI WHOLE BODY MR IMAGING SYSTEM

Radiology · 100d

Cleared Sep 21, 1994

MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1

Radiology · 100d