Medical Device Manufacturer · JP , Tokyo

Hitachi Medical Corp. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1982

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hitachi Medical Corp. Radiology ✕

10 devices

1-10 of 10

Cleared Jan 18, 2008

OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL

Radiology · 56d

Cleared Nov 22, 2006

MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

Radiology · 166d

Cleared Dec 09, 2005

EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER

Radiology · 17d

Cleared Feb 11, 2002

MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER

Radiology · 94d

Cleared Feb 06, 2002

MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER

Radiology · 89d

Cleared Aug 10, 2001

MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER

Radiology · 24d

Cleared May 30, 2001

EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM

Radiology · 36d

Cleared Jun 03, 1994

Radiology · 541d

Cleared Apr 15, 1991

TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T

Radiology · 90d

Cleared Jul 13, 1982

MODEL LS 3000 LINEAR SCANNER

Radiology · 84d