Medical Device Manufacturer · US , Tarrytown , NY

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

32 submissions · 31 cleared · Since 1985

Recent clearances: EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER, CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS, CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

Total

Cleared

Denied

Hitachi Medical Corp. of America has 31 FDA 510(k) cleared radiology devices. Based in Tarrytown, US.

Historical record: 31 cleared submissions from 1985 to 2000.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Hitachi Medical Corp. of America is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Hitachi Medical Corp. of America

32 devices

1-12 of 32

Cleared Mar 29, 2000

EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER

K994026 · IYN

Radiology · 124d

Cleared Jul 30, 1999

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

K991535 · KPS

Radiology · 88d

Cleared Jun 18, 1999

CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

K991318 · KPS

Radiology · 60d

Cleared May 13, 1999

HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL

K991129 · KPS

Radiology · 41d

Cleared Jul 27, 1998

EUP-OL334 LAPARASCOPICPROBE

SPECTRADIGITAL SERIES V250DSP

K954129 · KPS

Radiology · 112d

Cleared Dec 22, 1995

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS

K954143 · KPS

Radiology · 112d

Cleared Nov 20, 1995

HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100

ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED

K912364 · ITX

Radiology · 455d

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

FDA 510(k) Regulatory Record - Hitachi Medical Corp. of America

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