| MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL (K082627) | Minxray, Inc. | 2008-11-07 |
| 1.5T ATLAS SPEEDER HEAD-NECK COIL (K083160) | Quality Electrodynamics | 2008-11-07 |
| ONCENTRA RT VIEWER 1.0 (K082642) | Nucletron Corporation | 2008-11-07 |
| PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS (K082243) | General Medical Merate S.P.A | 2008-11-07 |
| SYNGO MR B17 (K082427) | Siemens Medical Solutions USA, Inc. | 2008-11-07 |
| DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS (K082261) | Dxrad Solutions , Ltd. | 2008-11-06 |
| HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL (K082987) | Invivo | 2008-11-06 |
| INFINITT CARDIOLOGY PACS (K082706) | Infinitt Co., Ltd. | 2008-11-06 |
| DISCOVERY MR450 (K083147) | Ge Medical Systems, LLC | 2008-11-04 |
| SONIXTOUCH ULTRASOUND SYSTEM (K083095) | Ultrasonix Medical Corporation | 2008-10-31 |
| MASTER3DS (K082410) | E-Woo Technology | 2008-10-31 |
| APPLICATORS FOR AFTERLOADING BRACHYTHERAPY (K082530) | Isodose Control B.V. | 2008-10-30 |
| DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 (K082798) | Medicatech USA | 2008-10-28 |
| MEDICAL DISPLAY, MD205MG-1 (K082493) | Nec Display Solutions , Ltd. | 2008-10-23 |
| RAYDOSE (K082221) | Raysearch Laboratories AB | 2008-10-22 |
| M5 DIAGNOSTIC ULTRASOUND SYSTEM (K083001) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-10-22 |
| SHOWCASE (K082135) | Trillium Technology, Inc. | 2008-10-21 |
| ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A (K083014) | Toshiba America Medical Systems, In.C | 2008-10-17 |
| GE XTREME INJECTOR OPTION (K082960) | Ge Medical Systems, LLC | 2008-10-17 |
| P3T ABDOMEN (K082458) | Medrad, Inc. | 2008-10-17 |
| VB IMAGE VIEWER (K080581) | Olympus Medical Systems Corporation | 2008-10-16 |
| OSDX HIP BMD SYSTEM (K082402) | Imaging Therapeutics, Inc. | 2008-10-16 |
| HRB-127-32 HIGH RESOLUTION BRAIN COIL (K082916) | Invivo | 2008-10-15 |
| XR-EXPRESS (K082336) | New Mexico Software, Inc. | 2008-10-15 |
| 4D VIEWER RADIOLOGY, MODEL USWP-100A (K082684) | Toshiba America Medical Systems, In.C | 2008-10-14 |
| SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 (K082543) | Sonocine, Inc. | 2008-10-14 |
| INFX-8000H, INFINIX-I (K082830) | Toshiba America Medical Systems, In.C | 2008-10-10 |
| SOMATOM FLASH DS (K082220) | Siemens Medical Solutions USA, Inc. | 2008-10-10 |
| CENTERING INTRALUMINAL APPLICATOR (K082653) | Varian Medical Systems, Inc. | 2008-10-10 |
| PAX-500 (K082350) | VATECH Co., Ltd. | 2008-10-10 |
| ZONARE ULTRA ULTRASOUND SYSTEM (K082326) | Zonare Medical Systems, Inc. | 2008-10-08 |
| S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM (K082229) | Volcano Corporation | 2008-10-08 |
| GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM (K082816) | Ge Medical Systems, LLC | 2008-10-08 |
| GE LIGHTSPEED 7.2 CT SCANNER SYSTEM (K082761) | Ge Medical Systems, LLC | 2008-10-08 |
| STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 (K081935) | Aktina Medical Physics Corp. | 2008-10-07 |
| COLOR LCD MONITOR (K082663) | Eizo Nanao Corporation | 2008-10-06 |
| MAGNETOM C! (K082331) | Siemens Medical Solutions USA, Inc. | 2008-10-01 |
| IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 (K082510) | Tomtec Imaging Systems GmbH | 2008-10-01 |
| IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR (K082364) | Topcon Corp. | 2008-09-30 |
| CIVASTRING PD-103 (K082159) | Civatech Oncology, Inc. | 2008-09-30 |
| MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT (K082656) | Fukuda Denshi USA, Inc. | 2008-09-30 |
| UNISYN IMAGE FUSION, VERSION 1.0 (K081987) | Convergent Imaging Solutions | 2008-09-26 |
| GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION (K082317) | General Electric Co. | 2008-09-26 |
| MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) (K081386) | Esaote, S.p.A. | 2008-09-25 |
| TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T (K082636) | Quality Electrodynamics | 2008-09-25 |
| AW SERVER (K081985) | Ge Medical Systems, LLC | 2008-09-25 |
| ULTRAEXTEND USWS-900A (K082596) | Toshiba America Medical Systems, In.C | 2008-09-23 |
| PLANISIGHT LINASYS (K082228) | Pathfinder Therapeutics, Inc. | 2008-09-22 |
| RAYPAX SYSTEM (K081948) | Raypax, Inc. | 2008-09-19 |
| SPY ANALYSIS TOOLKIT, MODEL SA9000 (K081792) | Novadaq Technologies, Inc. | 2008-09-17 |
| MODIFICATION TO AURORA MRI SYSTEM (K073425) | Aurora Imaging Technology, Inc. | 2008-09-16 |
| INREACH PLANNING LAPTOP (K082386) | Superdimension, Ltd. | 2008-09-16 |
| 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A) (K081945) | Totoku Electric Co., Ltd. | 2008-09-12 |
| CONTURA LUMEN MARKER (K082264) | Senorx, Inc. | 2008-09-12 |
| DRAD3000E/RADREX-I (K082494) | Toshiba America Medical Systems, In.C | 2008-09-12 |
| CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM (K082368) | Digirad Corp. | 2008-09-12 |
| QUANTRA (K082483) | Hologic, Inc. | 2008-09-12 |
| VISUALASE THERMAL THERAPY SYSTEM (K081656) | Biotex, Inc. | 2008-09-10 |
| PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (K081557) | Jddb Manufacturing, Inc. | 2008-09-10 |
| CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA (K073328) | Paieon, Inc. | 2008-09-09 |
| MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A (K082485) | Neusoft Medical Systems Co., Ltd. | 2008-09-09 |
| UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM (K081919) | Fukuda Denshi Co., Ltd. | 2008-09-09 |
| PACSMATE MMD-3213M MONITOR (K082496) | Iei Technology Corp. | 2008-09-09 |
| AMICAS PACS, VERSION 6.0 (K082144) | Amicas, Inc. | 2008-09-05 |
| 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) (K081357) | Eizo GmbH | 2008-09-05 |
| Z3D CONTRAST ACUITY (K080196) | Clario Medical Imaging, Inc. | 2008-09-05 |
| GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM (K082104) | Ge Medical Systems, Inc. | 2008-09-02 |
| 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION (K080711) | Hologic, Inc. | 2008-09-02 |
| VIVID I AND VIVID Q (K082374) | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008-09-02 |
| MLCI2 (K082122) | Elekta , Ltd. | 2008-08-29 |
| DSA 2000EX (K082341) | Eigen, LLC | 2008-08-29 |
| NORAS MR-BI320-PA 3T (K082373) | Noras Mri Products GmbH | 2008-08-29 |
| STEREOS WORKSTATION (K080529) | Biospace Med | 2008-08-29 |
| VOLUMINA (K081215) | Kjaya Medical, LLC | 2008-08-26 |
| MODIFICATION TO HI-ART TREATMENT SYSTEM (K082005) | Tomotherapy Incorporated | 2008-08-25 |
| SONOSITE MAXX SERIES ULTRASOUND SYSTEM (K082098) | Sonosite,Inc. | 2008-08-25 |
| CENTRICITY PACS IW (K082318) | Ge Healthcare Dynamic Imaging Solutions | 2008-08-25 |
| RADVISION ET DIAGNOSTIC X-RAY SYSTEM (K082064) | Almana Medical Imaging | 2008-08-22 |
| YSIO (K081722) | Siemens Medical Solutions USA, Inc. | 2008-08-22 |
| PICASSO MASTER, ECT AND MASTER 3D (K081847) | E-Woo Technology | 2008-08-21 |
| PCA-8000A, MARK 11, PET / CT SYSTEM (K082244) | Toshiba America Medical Systems, In.C | 2008-08-21 |
| GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 (K082185) | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-08-15 |
| VERISTA IMAGING ISOCAM II GAMMA CAMERA (K081757) | Verista Imaging, Inc. | 2008-08-15 |
| C-INSIGHT (K081672) | Mazor Surgical Technologies , Ltd. | 2008-08-15 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 (K082119) | Toshiba America Medical Systems, In.C | 2008-08-12 |
| ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL (K081745) | Hitachi Medical Systems America, Inc. | 2008-08-12 |
| MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS (K080930) | U-System, Inc. | 2008-08-07 |
| ATLAS-BASED AUTOSEGMENTATION (K080799) | Computerized Medical Systems, Inc. | 2008-08-07 |
| RFVISION, MODEL 9.9D (K080847) | Almana Medical Imaging | 2008-08-06 |
| ALLTECH ECHOSTAR 1.5 T MR SYSTEM (K082100) | Alltech Medical Systems America, Inc. | 2008-08-06 |
| EDGE PACS (K081752) | Ashva Technologies, Pvt., Ltd. | 2008-08-06 |
| GE VIVID E9 ULTRASOUND (K081921) | General Electric Co. | 2008-08-06 |
| SONIX MDP ULTRASOUND SCANNER (K080935) | Ultrasonix Medical Corporation | 2008-08-06 |
| MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM (K081859) | Sicel Technologies, Inc. | 2008-08-04 |
| FIATLUX VISUALIZE (K082041) | Fiatlux Imaging, Inc. | 2008-08-01 |
| CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM (K081836) | Carestream Health, Inc. | 2008-07-30 |
| THD SLIDE (K081429) | Thd Spa | 2008-07-30 |
| MAMMO WORKSTATION (K081630) | Image Diagnost International GmbH | 2008-07-29 |
| RSVP PHANTOM PELVIS, MODEL TLP260 (K081760) | The Phantom Laboratory, Inc. | 2008-07-29 |
| FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM (K081112) | Isodose Control B.V. | 2008-07-29 |