FDA 510(k) Applications Submitted by JAMES ROGERS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K061857 |
06/30/2006 |
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR |
BIO COMPRESSION SYSTEMS, INC. |
| K974498 |
11/28/1997 |
STRATIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K033897 |
12/16/2003 |
MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM |
AGA-LINDE HEALTH CARE |
| K180542 |
03/01/2018 |
NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe |
Boston Endo Surgical Tech, |
| K131058 |
04/16/2013 |
BIPOLAR FORCEPS |
BOSTON ENDO-SURGICAL TECHNOLOGIES, INC. |
| K032928 |
09/22/2003 |
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1 |
MEDIPHYSICS PAIN CENTERS OF AMERICA |
| K182662 |
09/25/2018 |
NAV PAK Needle, NIM NAV PAK Needle |
Boston Endo Surgical Tech, |
| K170090 |
01/10/2017 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
| K960181 |
01/16/1996 |
VERSION 3.7 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K020433 |
02/08/2002 |
FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER |
IDT TECHNOLOGY LIMITED |
| K971016 |
03/20/1997 |
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K961174 |
03/25/1996 |
ECG MONITOR MODEL DS-3130/3140 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K961876 |
05/15/1996 |
AIRIS |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K961969 |
05/20/1996 |
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K962048 |
05/28/1996 |
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K012154 |
07/11/2001 |
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
AURORA IMAGING TECHNOLOGY, INC. |
| K212233 |
07/16/2021 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
| K092366 |
08/05/2009 |
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE |
THERMAL THERAPEUTIC SYSTEMS, INC |
| K142997 |
10/10/2014 |
RTHawk, HeartVista Workstation with RTHawk |
HEARTVISTA, INC. |
| K063354 |
11/06/2006 |
LINDE INTEGRATED VALVE (LIV) |
LINDE GAS THERAPEUTICS |
| K974212 |
11/10/1997 |
AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K003651 |
11/27/2000 |
AURORA |
AURORA IMAGING TECHNOLOGY, INC. |
| K133848 |
12/18/2013 |
RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK |
HEARTVISTA, INC. |
| K153740 |
12/28/2015 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
| K201400 |
05/28/2020 |
npSIMS Negative Pressure Surgical Incision Management SystemÖ (npSIMS)Ö |
Aatru Medical LLC |
| K183274 |
11/23/2018 |
RTHawk, HeartVista Cardiac Package |
HeartVista, Inc. |
| K980691 |
02/23/1998 |
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K971279 |
04/07/1997 |
VERSION 4 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K992650 |
08/06/1999 |
AIRIS, AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K072666 |
09/21/2007 |
BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
BIO COMPRESSION SYSTEMS, INC. |
| K984272 |
11/30/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K984274 |
11/30/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K984278 |
11/30/1998 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K984280 |
11/30/1998 |
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
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