| MAGNETOM AERA AND MAGNETOM SKYRA (K111242) | Siemens Medical Solutions USA, Inc. | 2011-11-23 |
| SDX-4343CS (K112751) | Samsung Mobile Display Co., Ltd. | 2011-11-23 |
| INGENUITY TF PET/MR (K103483) | Philips Healthcare (Cleveland) | 2011-11-23 |
| CAROTID COIL GE 1.5T (K113280) | Tursiop Technologies, LLC | 2011-11-23 |
| FRAXION (K112210) | Medical Intelligence Medizintechnik GmbH | 2011-11-22 |
| SYNGO AORTIC VALVEGUIDE SOFTWARE (K113027) | Siemens Medical Solutions USA, Inc. | 2011-11-22 |
| INFINIX-CCI (K113052) | Toshiba America Medical Systems, In.C | 2011-11-22 |
| SAFIRE (K103424) | Siemens Medical Solutions USA, Inc. | 2011-11-22 |
| CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING (K112768) | Calypso Medical Technologies, Inc. | 2011-11-18 |
| MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM (K110596) | Wide Corporation | 2011-11-18 |
| CAROTID COIL (K112002) | Shanghai Chenguang Medical Technologies Co, Ltd. | 2011-11-18 |
| SYNGO VIA MI WORKFLOWS (K113029) | Siemens Medical Solutions USA, Inc. | 2011-11-18 |
| ONCO TRAC MODEL 1, 2, 4 (K111642) | Translational Sciences Corporation | 2011-11-18 |
| KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (K112132) | Medicatech USA | 2011-11-18 |
| VITREA CT MYOCARDIAL ANALYSIS (K112531) | Vital Images, Inc. | 2011-11-18 |
| ONCENTRA PROSTATE 4.0 (K112420) | Nucletron | 2011-11-18 |
| SONOSITE EDGE ULTRASOUND SYSTEM (K113156) | Sonosite,Inc. | 2011-11-15 |
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K112839) | Varian Medical Systems | 2011-11-14 |
| DIGITAL FLAT PANEL X-RAY DETECTOR (K112558) | Samsung Mobile Display Co., Ltd. | 2011-11-10 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K113063) | Activiews, Ltd. | 2011-11-10 |
| MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 (K112145) | Totoku Electric Co., Ltd. | 2011-11-07 |
| S6 DIAGNOSTIC ULTRASOUND SYSTEM (K112602) | Sonoscape Company Limited | 2011-11-07 |
| FXA (TM) (K110765) | Aces GmbH | 2011-11-04 |
| PERFSCAPE V2.0 (K111161) | Olea Medical | 2011-11-04 |
| UC-CARE NAVIGO SYTEM (K100784) | UC-CARE , Ltd. | 2011-11-01 |
| 4MP COLOR LCD MONITOR, RADIFORCERX430 (K112466) | Eizo Nanao Corporation | 2011-10-27 |
| DX-D 600 (K112670) | Agfa Healthcare N.V. | 2011-10-27 |
| GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L (K111434) | Giotto USA, LLC | 2011-10-27 |
| 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) (K112604) | Totoku Electric Co., Ltd. | 2011-10-27 |
| VIZION DR (K112661) | Viztek, LLC | 2011-10-20 |
| DIGIVIEW 250 (K103348) | Kub Technologies, Inc. | 2011-10-20 |
| CARESTREAM PACS (K110919) | Carestream Health, Inc. | 2011-10-20 |
| PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K112974) | Curve Dental, Inc. | 2011-10-20 |
| RADIOACTIVE SEED LOCALIZATION NEEDLE (K111979) | Biocompatibles, Inc. | 2011-10-18 |
| SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 (K112439) | Fujifilm Medical System U.S.A., Inc. | 2011-10-17 |
| CORONIS 5MP (K111990) | Barco N.V. | 2011-10-17 |
| SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING (K111311) | Omisa Inc. (Segasist Technologies) | 2011-10-17 |
| LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE (K112051) | Broncus Technologies, Inc. | 2011-10-12 |
| SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM (K112646) | Samsung Medison Co., Ltd. | 2011-10-12 |
| BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER (K110646) | Beam-Med, Ltd. | 2011-10-12 |
| TOMOTHERAPY TREATMENT SYSTEM (K112446) | Tomotherapy Incorporated | 2011-10-07 |
| MULTIPLE (K112460) | Larson Medical Products, Inc. | 2011-10-07 |
| SENOGRAPH DS, SENOGRAPH ESSENSTIAL (K103485) | General Electric Company | 2011-10-06 |
| DRYVIEW CHROMA IMAGING SYSTEM (K111566) | Carestream Health, Inc. | 2011-10-06 |
| OEC(R) 9800, OEC(R) 9800 PLUS (K111551) | Ge Oec Medical Systems, Inc. | 2011-10-04 |
| FLAATZ 560 (K111583) | Drtech Corp. | 2011-10-04 |
| APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM (K110870) | Toshiba America Medical Systems, In.C | 2011-10-04 |
| HTS EXTREMITY COIL, HTS SURFACE COIL (K112293) | Time Medical Systems, Inc. | 2011-09-30 |
| APEX (K111676) | Elekta Limited | 2011-09-30 |
| WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE (K111865) | Fujifilm Medical System U.S.A., Inc. | 2011-09-30 |
| 3DI INCLUDING CSCORE (K112530) | Shina Systems , Ltd. | 2011-09-30 |
| IMAGELINK (K112096) | Computer Programs and Systems, Inc. | 2011-09-30 |
| SURGIMAP (TM) SPINE (K111019) | Nemaris, Inc. | 2011-09-30 |
| DISCOVERY MR750W 3.0T (K103327) | Ge Healthcare Japan Corporation | 2011-09-30 |
| SONIX ULTRASOUND SCANNER (K112726) | Ultrasonix Medical Corporation | 2011-09-27 |
| HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER (K110673) | Hitachi Medical Systems America, Inc. | 2011-09-27 |
| LOGIQ P3 (K112371) | GE Healthcare | 2011-09-27 |
| 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR (K111496) | Totoku Electric Co., Ltd. | 2011-09-26 |
| SURGICASE ORTHOGNATHIC SOFTWARE WIZARD (K111641) | Materialise NV | 2011-09-26 |
| MAMMODIAGNOST DR (K110572) | Philips Medical Systems | 2011-09-23 |
| PLANMED NUANCE EXCEL (K111361) | Planmeca USA, Inc. | 2011-09-23 |
| LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (K111791) | Gamma Medica-Ideas Incorporated | 2011-09-23 |
| VENUE 40 (K112122) | GE Healthcare | 2011-09-23 |
| CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE (K112474) | Cedars-Sinai Medical Center | 2011-09-23 |
| DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K112022) | Advanced Instrumentations, Inc. | 2011-09-22 |
| CORONIS FUSION 4MP DL (K111989) | Barco N.V. | 2011-09-22 |
| VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET (K111973) | Nucletron | 2011-09-21 |
| VIRTUE (K111833) | Diagnosoft, Inc. | 2011-09-21 |
| MOBILETT MIRA (K111912) | Siemens Medical Solutions USA, Inc. | 2011-09-19 |
| S8 DIAGNOSTIC ULTRASOUND SYSTEM (K112451) | Sonoscape Company Limited | 2011-09-16 |
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K112596) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2011-09-16 |
| ASTRA (K111694) | Candelis, Inc. | 2011-09-15 |
| EQUAL DOSE (K103515) | Nucletron Corporation | 2011-09-15 |
| FEEL-DRCS (K110033) | Imfou Co., Ltd. | 2011-09-15 |
| 4CH FLEX SPEEDER (K112366) | Toshiba Medical Systems Coporation, Japan | 2011-09-15 |
| MOLECULAR BREAST IMAGING SOFTWARE (K111731) | Gamma Medica-Ideas Incorporated | 2011-09-15 |
| R4 ACERT ULTRASOUND REPORTING SYSTEM (K101898) | R4, LLC | 2011-09-15 |
| XELIS CARDIAC (K111660) | Infinitt Co., Ltd. | 2011-09-13 |
| GE VEO RECONSTRUCTION OPTION (K103489) | General Electric Co. | 2011-09-09 |
| .DECIMAL ELECTRON APERTURE (K111759) | .Decimal, Inc. | 2011-09-09 |
| MRGFUS PELVIC PA COIL MODEL 1.0 (K111060) | Insightech, Ltd. | 2011-09-09 |
| TOSHIBA 3T EXTRA LARGE KNEE COIL (K112313) | Quality Electrodynamics | 2011-09-09 |
| RESOLUTIONMD MOBILE MODEL RMB-MOB-2X (K111346) | Calgary Scientific, Inc. | 2011-09-09 |
| XELIS FUSION (K111613) | Infinitt Co., Ltd. | 2011-09-08 |
| SV BRAIN ARRAY, SIEMENS 3T (K111802) | Mri Interventions, Inc. | 2011-09-08 |
| DIGITAL RADIOGRAPHY (K111682) | Canon Inc. -Medical Equipment Group | 2011-09-02 |
| DIGITAL RADIOGRAPHY (K112309) | Canon Inc. -Medical Equipment Group | 2011-09-02 |
| VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM (K112213) | GE Healthcare | 2011-09-01 |
| ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM (K110729) | Fujifilm Medical Systems U.S.A, Inc. | 2011-09-01 |
| WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE (K111548) | Fujifilm Medical System U.S.A., Inc. | 2011-08-30 |
| ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM (K112339) | Samsung Medison Co., Ltd. | 2011-08-29 |
| AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE (K103308) | KARL STORZ Endoscopy-America, Inc. | 2011-08-29 |
| ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (K103181) | Genoray Co., Ltd. | 2011-08-26 |
| AQUILION LB MOVEMENT BASE KIT (K111633) | Toshiba America Medical Systems, In.C | 2011-08-25 |
| SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS (K112112) | Sentinel Medical, Inc. | 2011-08-25 |
| CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE (K111373) | Circle Cardiovascular Imaging, Inc. | 2011-08-23 |
| DDRELEMENT (K110828) | Swissray Medical AG | 2011-08-23 |
| TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 (K111508) | Hologic, Inc. | 2011-08-19 |
| TRUEBEAM (K111106) | Varian Medical Systems, Inc. | 2011-08-18 |
| XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (K111167) | Velopex International, Inc. | 2011-08-18 |