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."
49–72 of 100
Search insights Median review: 78d Cleared: 100% Top manufacturer: Hitachi Medical Systems America, Inc. Lead specialty: Radiology
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Mar 07, 2000
AIRIS II
K994378 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Oct 08, 1999
AIRIS, AIRIS II
K992650 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 63d
Cleared May 24, 1999
HITACHI VERSIFLEX
K991231 · IZI
Hitachi Medical Systems America, Inc.
Radiology · 42d
Cleared Feb 08, 1999
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
K984280 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Jan 25, 1999
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
K984274 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 56d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
K984278 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
K984272 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 11d
Cleared May 11, 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared Feb 26, 1998
STRATIS II
K974498 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 90d
Cleared Feb 09, 1998
AIRIS II
K974212 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 91d
Cleared Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
K971279 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Jun 06, 1997
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
K971016 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 78d
Cleared Feb 26, 1997
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
K964990 · JAA
Hitachi Medical Systems America, Inc.
Radiology · 72d
Cleared Sep 05, 1996
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6...
K961969 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 108d
Cleared Aug 14, 1996
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
K962048 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 78d
Cleared Jul 25, 1996
AIRIS
K961876 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Jun 21, 1996
ECG MONITOR MODEL DS-3130/3140
K961174 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 88d
Cleared Mar 05, 1996
VERSION 3.7 OPERATING SYSTEM SOFTWARE
K960181 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Oct 23, 1995
IRIS BILATERAL TMJ
K953248 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Oct 17, 1995
QD BILATERAL BREAST COIL
K953262 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K953918 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 25d
Cleared May 24, 1995
AIRIS
K945155 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 215d