FDA 510(k) Applications Submitted by T W ATHEY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K984285 |
12/01/1998 |
OSTEOGRAM BONE DENSITOMETER |
COMPUMED, INC. |
| K973963 |
10/16/1997 |
120 LEAF MULTILEAF COLLIMATOR |
MITSUBISHI ELECTRONICS AMERICA, INC. |
| K032424 |
08/05/2003 |
LOTUS |
SRA DEVELOPMENTS, LTD. |
| K020268 |
01/25/2002 |
ISAAC 1.5 T MR SYSTEM |
CHI, INC. |
| K972409 |
06/26/1997 |
AG CHEMISTRY ANALYZER SYSTEM |
LANDMARK SCIENTIFIC, INC. |
| K003775 |
12/06/2000 |
PORTABLE BREAST COMPRESSION DEVICE |
PEM TECHNOLOGIES |
| K970564 |
02/13/1997 |
DYNAMIC WEDGE |
MITSUBISHI ELECTRONICS AMERICA, INC. |
| K010571 |
02/26/2001 |
ADC QS/IPD WORKSTATION |
AGFA CORP. |
| K020643 |
02/27/2002 |
EZ-SCOPE AN & EZ-SCOPE AN LITE |
HEALTH POLICY RESORTERS GROUP, LLC |
| K040587 |
03/05/2004 |
MINI GAMMA CAMERA, MODEL MGC-500 |
ACRORAD CO., LTD. |
| K990787 |
03/10/1999 |
TRIO 300 |
ITO CO., LTD. |
| K971001 |
03/19/1997 |
AUTIMO |
MEDIZINTECHNIK, GMBH |
| K020924 |
03/21/2002 |
CUSTODIOL HTK SOLUTION |
DR. FRANZ KOHLER CHEMIE GMBH |
| K981124 |
03/27/1998 |
ACCUDEXA BONE DENSITOMETER |
SCHICK TECHNOLOGIES, INC. |
| K050866 |
04/05/2005 |
CENTRION 500 C-ARM SYSTEM |
OSTEOSYS CO., LTD. |
| K991231 |
04/12/1999 |
HITACHI VERSIFLEX |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K031327 |
04/25/2003 |
VERICOR |
CVP DIAGNOSTICS, INC. |
| K051053 |
04/25/2005 |
OSCAR, MODEL OE3000DB |
ORTHOSONICS, LTD. |
| K031385 |
05/01/2003 |
ANZAI AZ-733 RESPIRATORY GATING SYSTEM |
ANZAI MEDICAL CO, LTD. |
| K021502 |
05/09/2002 |
OSCAR, MODEL OE3000 |
ORTHOSONICS, LTD. |
| K971735 |
05/12/1997 |
ACCUDEXA BONE DENSITOMETER |
SCHICK TECHNOLOGIES, INC. |
| K972016 |
05/30/1997 |
AUTIMO 2.5-D AND AUTIMO 3-D |
C.L. MCINTOSH & ASSOC., INC. |
| K972093 |
06/04/1997 |
REGENESIS MODEL 42 |
REGENESIS BIOMEDICAL, INC. |
| K982171 |
06/19/1998 |
HAMAMATSU PET SCANNER, MODEL SHR-22000 |
HAMAMATSU PHOTONICS, K.K. |
| K972309 |
06/20/1997 |
JM-102 JAUNDICE METER |
AIR-SHIELDS, INC. |
| K992209 |
06/30/1999 |
CUSTODIOL |
DR. FRANZ KOHLER CHEMIE GMBH |
| K022342 |
07/18/2002 |
EZ-SCOPE AN, EZ-SCOPE LIGHT |
ANZAI MEDICAL CO, LTD. |
| K972719 |
07/21/1997 |
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS |
MEDICEL, S.A. DE C.V. |
| K012349 |
07/24/2001 |
METAVISION CLINICAL INFORMATION SYSTEM |
IMDSOFT, LTD. |
| K992545 |
07/30/1999 |
TM-300 TRACTION SYSTEM |
ITO CO., LTD. |
| K982862 |
08/13/1998 |
RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE |
APPLICARE MEDICAL IMAGING, B.V. |
| K012750 |
08/16/2001 |
ADC PEDIATRIC |
AGFA CORP. |
| K973223 |
08/27/1997 |
STELLAR MODEL HS-04 |
STELLAR MEDICAL CORP. |
| K022846 |
08/27/2002 |
SW-180 SHORTWAVE THERAPY UNIT |
ITO CO., LTD. |
| K012941 |
08/31/2001 |
DRYSTAR, MODEL 4500M |
AGFA CORP. |
| K013006 |
09/06/2001 |
OVUS CAPLESS SAFETY NEEDLE |
OVUS SYSTEMS |
| K032794 |
09/08/2003 |
CUSTODIOL |
DR. FRANZ KOHLER CHEMIE GMBH |
| K032793 |
09/09/2003 |
US-100 PORTABLE ULTRASOUND THERAPY UNIT |
ITO CO., LTD. |
| K013138 |
09/19/2001 |
ADC COMPACT PLUS |
AGFA-GEVAERT AG |
| K013167 |
09/21/2001 |
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 |
NEWCARE PRODUCTS, LLC. |
| K993501 |
10/15/1999 |
3D1 MICROPOSITIONING HEADSTAGE |
SCIENTIFIC TOOLS, INC. |
| K983647 |
10/16/1998 |
ECHO-COAT ULTRASOUND NEEDLES |
STS BIOPOLYMERS |
| K003507 |
11/13/2000 |
MEDRELIEF |
HEALTHONICS, INC. |
| K043293 |
11/29/2004 |
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U |
ACRORAD CO., LTD. |
| K043461 |
12/15/2004 |
CUSTODIOL |
DR. FRANZ KOHLER CHEMIE GMBH |
| K964990 |
12/16/1996 |
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K965079 |
12/19/1996 |
SOMNITOR 32K SLEEP ACTIVITY MONITOR |
NEURIM PHARMACEUTICALS, LTD. |
| K970131 |
01/14/1997 |
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE |
C.L. MCINTOSH & ASSOC., INC. |
| K990202 |
01/21/1999 |
SUGITA TITANIUM ANEURYSM CLIP |
MIZUHO AMERICA, INC. |
| K012010 |
06/27/2001 |
MODIFICATION TO LR 5200 FILM RECORDER |
AGFA CORP. |
|
|
