| IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION (K081976) | Agfa Healthcare Corporation | 2008-07-28 |
| AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS (K081963) | Agfa Healthcare Corporation | 2008-07-25 |
| GE SIGNA MR ONCOLOGY PACKAGE (K081916) | Ge Medical Systems, LLC | 2008-07-22 |
| SAVI APPLICATOR KIT (K081677) | Cianna Medical, Inc. | 2008-07-22 |
| BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST (K081218) | It-V Medizintechnik, GmbH | 2008-07-21 |
| SIMPLANT ORTHO ; VISTADENT 3D (K081402) | Materialise Dental NV | 2008-07-18 |
| STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE (K081512) | Medtronic Navigation, Inc. | 2008-07-18 |
| QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI (K080905) | Quantum Medical Imaging, LLC | 2008-07-16 |
| EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE (K081873) | Shenzhen Emperor Electronic Technology Co. , Ltd. | 2008-07-16 |
| ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 (K081843) | Aloka Co., Ltd. | 2008-07-15 |
| TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE (K081188) | Varian Medical Systems, Inc. | 2008-07-14 |
| CX50 DIAGNOSTIC ULTRASOUND SYSTEM (K081802) | Philips Ultrasound, Inc. | 2008-07-11 |
| CAPIMAGE (K081829) | Danish Diagnostic Development A/S | 2008-07-11 |
| MODEL 7340 ULTRASOUND SYSTEM (K081794) | Esaote, S.p.A. | 2008-07-10 |
| NUWAV (K081781) | Laborie Medical Technologies, Corp. | 2008-07-09 |
| SYNGO IMAGING (VERSION V31) (K081734) | Siemens AG Medical Solutions | 2008-07-03 |
| SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM (K081676) | Medison Co., Ltd. | 2008-07-02 |
| LASER IMAGER DRYPRO MODEL 873 (K081637) | Konica Minolta Medical & Graphic, Inc. | 2008-07-01 |
| IPLAN RT IMAGE (K080886) | Brainlab AG | 2008-06-24 |
| DIGITAL RADIOGRAPHY CXDI-60G (K081648) | Canon, Inc. | 2008-06-24 |
| ZURA TEE SYSTEM (K080223) | Imacor, LLC | 2008-06-24 |
| HD15 DIAGNOSTIC ULTRASOUND SYSTEM (K081661) | Philips Ultrasound, Inc. | 2008-06-24 |
| INFX-8000F (INFINIX CSI AND INFINIX DPI) (K081624) | Toshiba America Medical Systems, In.C | 2008-06-23 |
| BIOGRAPH HD FAMILY (K081453) | Siemens Medical Solutions USA, Inc. | 2008-06-23 |
| INFX-8000C (INFINIX CC-I AND VC-I) (K081621) | Toshiba America Medical Systems, In.C | 2008-06-23 |
| DR VISION NEO, DR VISION DOU (K080614) | Almana Medical Imaging | 2008-06-20 |
| VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE (K081076) | Velocity Medical Solutions, LLC | 2008-06-20 |
| SMITH & NEPHEW CDS SYSTEM (K081491) | Smith & Nephew, Inc. | 2008-06-19 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL (K081322) | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 |
| PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 (K081340) | Shanghai Chenguang Medical Technologies Co, Ltd. | 2008-06-18 |
| ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N (K081198) | Hitachi Medical Systems America, Inc. | 2008-06-18 |
| INFX-8000V, INFINIX-CFI AND INFINIX VFI (K081582) | Toshiba America Medical Systems, In.C | 2008-06-17 |
| DC NEURO (K081262) | Invivo Corporation | 2008-06-17 |
| SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 (K081469) | Sectra Imtec AB | 2008-06-12 |
| OPTIMA PET/CT 560 (K081496) | Ge Medical Systems, LLC | 2008-06-12 |
| USHIFU STEPPER (K080970) | Ushifu Development Company, LLC | 2008-06-11 |
| ALZ WEB PACS, VERSION 1.0 (K081304) | Alz, Inc. | 2008-06-11 |
| SATURN 9000-810 (K080589) | New Medical Co., Ltd. | 2008-06-11 |
| DESKTOP PRO (K080585) | Elekta , Ltd. | 2008-06-11 |
| CSBP-001A BODY ORGAN PERFUSION SYSTEM (K081482) | Toshiba America Medical Systems, In.C | 2008-06-11 |
| PRECISION 500D R&F X-RAY SYSTEM (K081091) | GE Healthcare | 2008-06-11 |
| MODEIFICATION TO IPLAN RT DOSE (K080888) | Brainlab AG | 2008-06-11 |
| MODIFICATION TO INREACH SYSTEM (K081379) | Superdimension, Ltd. | 2008-06-11 |
| 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A) (K081242) | Tokotu Electric Co., Ltd. | 2008-06-11 |
| APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 (K081065) | Toshiba America Medical Systems, In.C | 2008-06-06 |
| ERGO++ VERSION 1.7 (K080601) | 3D Line Medical Systems S.R.L. | 2008-06-06 |
| FUJIFILM FCR VIEW, MODEL CR-VW674 (K081308) | Fujifilm Medical Systems U.S.A, Inc. | 2008-06-04 |
| 21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A) (K081055) | Totoku Electric Co., Ltd. | 2008-06-04 |
| MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM (K081121) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-06-04 |
| 21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A) (K081056) | Totoku Electric Co., Ltd. | 2008-06-04 |
| DRF 4343 (K080859) | Villa Sistemi Medicali S.P.A. | 2008-06-04 |
| MRI PATIENT POSITIONING DEVICES (K080072) | CIVCO Medical Instruments Co., Inc. | 2008-06-04 |
| NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE (K081426) | Philips Medical Systems (Cleveland), Inc. | 2008-06-04 |
| SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) (K080555) | Ivu Imaging Corporation | 2008-06-03 |
| SOMATOM DEFINITION, MODEL AS/AS+ (K081022) | Siemens Medical Solutions USA, Inc. | 2008-06-02 |
| 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A (K080952) | Totoku Electric Co., Ltd. | 2008-05-29 |
| 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A (K080951) | Totoku Electric Co., Ltd. | 2008-05-29 |
| WBR XPRESS3.CARDIAC (K081201) | Ultraspect , Ltd. | 2008-05-28 |
| ILUMA VISION (K081347) | Imtec Corp. | 2008-05-28 |
| VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET (K080934) | Nucletron Corporation | 2008-05-28 |
| DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K081320) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-05-27 |
| ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 (K081154) | B-K Medical Aps | 2008-05-23 |
| MROPEN (K073362) | Paramed S.R.L. | 2008-05-23 |
| OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) (K081281) | Nucletron Corporation | 2008-05-20 |
| BI-RADS COMPANION (K072258) | Almen Laboratories, Inc. | 2008-05-16 |
| SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM (K081110) | Shantou Institute of Ultrasonic Instuments | 2008-05-16 |
| FMRI HARDWARE SYSTEM (K080515) | Nordicneurolab | 2008-05-16 |
| MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA (K080582) | Medicatech USA | 2008-05-15 |
| IB NEURO, VERSION 1.0 (K080762) | Imaging Biometrics, LLC | 2008-05-15 |
| SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION (K080701) | Shimadzu Corp. | 2008-05-14 |
| CALYPSO 4D LOCALIZATION SYSTEM (K080726) | Calypso Medical Technologies, Inc. | 2008-05-14 |
| CORRIDOR4DM (K080575) | Invia | 2008-05-13 |
| GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) (K081105) | GE Healthcare | 2008-05-09 |
| LEICA FL800 (K080612) | Leica Microsystems (Schweiz) AG | 2008-05-09 |
| MAMMOSITE CAVITY EVALUATION DEVICE (K081179) | Hologic, Inc. | 2008-05-09 |
| 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) (K081036) | Varian Medical Systems, Inc. | 2008-05-09 |
| CHRYSALIS (K080655) | Meta Imaging Solutions, LLC | 2008-05-09 |
| AXXENT VAGINAL APPLICATOR (K072616) | Xoft, Inc. | 2008-05-09 |
| VERISUITE 1.6, VERISUITE-PARTICLE 1.6 (K080742) | Medcom GmbH | 2008-05-09 |
| BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 (K081066) | Medi-Physics, Inc., Dba GE Healthcare | 2008-05-05 |
| NORAS MR-BI320-PA 1.5T (K081118) | Noras Mri Products GmbH | 2008-05-02 |
| OEC 9900 ELITE (K073543) | Ge Oec Medical Systems | 2008-05-02 |
| CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY (K081079) | Senorx, Inc. | 2008-05-02 |
| CORONIS 5MP MAMMO SL, MODEL MDMG 6121 (K081109) | Barcoview, Medical Imaging Systems | 2008-05-02 |
| 3-D IMAGING WORKSTATION (K081093) | Eigen, LLC | 2008-05-01 |
| CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 (K080791) | Senorx, Inc. | 2008-04-30 |
| S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA (K080968) | Esaote, S.p.A. | 2008-04-29 |
| SMARTSPOT PRIMAX (K080890) | Cmt Medical Technologies, Ltd. | 2008-04-29 |
| TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS (K080871) | Nucletron Corporation | 2008-04-29 |
| GEMINI CONDOR (K081135) | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 |
| SIGNA 3.0T MR750 SYSTEM (K081028) | Ge Medical Systems, LLC | 2008-04-25 |
| ACUSON X300 ULTRASOUND SYSTEM (K080760) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-04-25 |
| LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A (K073358) | Heeyoung Co., Ltd. | 2008-04-25 |
| SYNGO DYNAMICS VERSION 7.0 (K081018) | Siemens Medical Solutions | 2008-04-25 |
| DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI (K080351) | Dexela, Ltd. | 2008-04-22 |
| SYNGO MULTIMODALITY WORKPLACE (K072728) | Siemens AG Medical Solutions | 2008-04-22 |
| FCR GO PORTABLE DIGITAL X-RAY SYSTEM (K080945) | Fujifilm Medical Systems U.S.A, Inc. | 2008-04-18 |
| NM APPLICATION SUITE (K080961) | Philips Nuclear Medicine, Inc. | 2008-04-18 |
| DIGITAL LIGHTBOX (K080608) | Brainlab AG | 2008-04-17 |
| ONCENTRA GYN (K080929) | Nucletron Corporation | 2008-04-16 |