Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

100 results for "Hitachi Medical Systems America, Inc."
73–96 of 100
Search insights Median review: 78d Cleared: 100% Top manufacturer: Hitachi Medical Systems America, Inc. Lead specialty: Radiology
Cleared May 12, 1995
MRH-1500
K943798 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 282d
Cleared Mar 21, 1995
STRATIS
K945386 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 138d
Cleared Dec 30, 1994
2D,3D, TOF MR ANGIOGRAPHY
K943800 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 149d
Cleared Dec 09, 1994
VERSION 5 OPERATING SYSTEM SOFTWARE
K943799 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 128d
Cleared Sep 23, 1994
QUAD PELVIS COIL
K943321 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 74d
Cleared Sep 09, 1994
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K942560 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 101d
Cleared May 23, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
K940602 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 102d
Cleared May 03, 1994
DIAGNOSTIC ULTRASOUND SYSTEM
K915403 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 881d
Cleared Mar 30, 1994
2D, 3D TOF MR ANGIOGRAPHY
K935671 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 124d
Cleared Mar 30, 1994
VERSION 3 OPERATING SYSTEM SOFTWARE
K935670 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 124d
Cleared Mar 16, 1994
FAST SPIN ECHO
K935664 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 110d
Cleared Jan 25, 1994
HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION
K934485 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 133d
Cleared Jan 05, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
K934719 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Dec 27, 1993
FAST SPIN ECHO
K934212 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 119d
Cleared Nov 12, 1993
ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
K933645 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 108d
Cleared Jun 08, 1993
MRH-1500
K922846 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 358d
Cleared Mar 18, 1993
FAST SPIN ECHO MEASURING FUNCTION
K926397 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Feb 12, 1993
2D TOF ANGIOGRAHY MEASURING FUNCTION
K925009 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 135d
Cleared Dec 24, 1992
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
K923140 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 178d
Cleared Dec 10, 1992
EUB-405
K924126 · IYO
Hitachi Medical Systems America, Inc.
Radiology · 115d
Cleared Aug 25, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K923010 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 64d
Cleared Jul 30, 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
K920441 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 178d
Cleared Mar 05, 1992
MOBILE MRP-7000
K920159 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Nov 22, 1991
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
K914263 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 60d