| SEDECAL, MILLENNIUM PLUS (K090279) | Sedecal., Sa. | 2009-03-11 |
| PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) (K082964) | Prism Clinical Imaging, Inc. | 2009-03-09 |
| CARDIUS 3 X-ACT (K083649) | Digirad Corp. | 2009-03-09 |
| CLEARVUE PRONE BREAST TREATMENT TABLE (K090349) | Orbital Therapy, LLC | 2009-03-09 |
| CSBP-001A BODY PERFUSION SYSTEM (K090504) | Toshibamedical Systems Corporation | 2009-03-05 |
| BODYVIZ, MODEL 100 (K090295) | Visual Medical Solutions, LLC | 2009-03-04 |
| DATACOM DC PACS (K083182) | Datacom Technology Corp. | 2009-03-04 |
| RADIONICS XKNIFE HDRT SYSTEM (K083414) | Integra Radionics, Inc. | 2009-03-02 |
| SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS (K090238) | Sedecal., Sa. | 2009-02-27 |
| BONEVUE (K083691) | Micromri, Inc. | 2009-02-25 |
| VISIX IMAGING (K082623) | Televere Systems | 2009-02-25 |
| NEONATE HEAD AND BODY COILS (K083541) | Advanced Imaging Research, Inc. | 2009-02-24 |
| RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS (K083645) | 5 Star Medical, Inc. | 2009-02-24 |
| RESOLUTIONMD, RELEASE 2.1 (K082693) | Calgary Scientific, Inc. | 2009-02-23 |
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K090334) | Siemens Medi Cal Solutions, Inc. | 2009-02-20 |
| NEUROSCAPE (K083491) | Olea Medical | 2009-02-19 |
| PRESCISION OPTION (K082775) | Siemens Medical Solutions USA, Inc. | 2009-02-19 |
| ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 (K090296) | Biodex Medical Systems, Inc. | 2009-02-19 |
| ECHELON C MRI SYSTEM (K083533) | Hitachi Medical Systems America, Inc. | 2009-02-17 |
| THE IC-PRO SYSTEM, MODEL VERSION 3.2 (K083745) | Paieon, Inc. | 2009-02-17 |
| DRAD30003/RADREX-I (K083503) | Toshiba America Medical Systems, In.C | 2009-02-13 |
| MAMMODIAGNOST VU (K083740) | Philips Medical Systems Nederland B.V. | 2009-02-13 |
| COLON VIEW, MODEL CSCV-001A (K090220) | Toshibamedical Systems Corporation | 2009-02-11 |
| AXXENT SURFACE APPLICATOR, MODEL 710257 (K083734) | Xoft, Inc. | 2009-02-11 |
| HUMANSCAN M5S-D ULTRASOUND TRANSDUCER (K083824) | Humanscan Company, Ltd. | 2009-02-10 |
| APLIO ARTIDA V2.0 SSH-880CV (K090158) | Toshiba America Medical Systems, In.C | 2009-02-06 |
| NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K090173) | Neusoft Medical Systems Co., Ltd. | 2009-02-05 |
| SICAT IMPLANT (K090119) | Sicat GmbH & Co. KG | 2009-02-05 |
| NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 (K083667) | B-K Medical Aps | 2009-02-02 |
| CADSTREAM, VERSION 5.0 (K081556) | Confirma, Inc. | 2009-02-02 |
| MYLABFIVE (K083882) | Esaote Europe B.V. | 2009-01-30 |
| PACS SCAN (K083618) | Pacsgear, Inc. | 2009-01-28 |
| THD SLIDE ONE (K090009) | Thd Spa | 2009-01-28 |
| COLOR LCD MONITOR, RADIFORCE RX320 (K090045) | Eizo Nanao Corporation | 2009-01-28 |
| RADPRO ION (K083725) | Virtual Imaging, Inc. | 2009-01-22 |
| RAYAUTOPLAN 1.0 (K083264) | Raysearch Laboratories AB | 2009-01-22 |
| IMAGE STORAGE SYSTEM, MODEL KSS-400 (K081797) | Konan Medical, Inc. | 2009-01-22 |
| PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C (K090044) | Oncolog Medical QA AB | 2009-01-22 |
| NORAS CPC MULTIFUNCTIONAL COIL (K083578) | Noras Mri Products GmbH | 2009-01-16 |
| LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD (K083916) | Nec Display Solutions , Ltd. | 2009-01-14 |
| ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE (K083149) | Siemens Medical Solutions USA, Inc. | 2009-01-14 |
| SPECIALTY COILS FOR THE MAGNETOM ESSENZA (K083166) | Siemens Medical Solutions USA, Inc. | 2009-01-13 |
| FLYING DIAGNOSTIC ULTRASOUND SYSTEM (K083877) | Neusoft Medical Systems Co., Ltd. | 2009-01-13 |
| MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG (K083907) | Nec Display Solutions , Ltd. | 2009-01-13 |
| MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK (K083332) | Nec Display Solutions , Ltd. | 2009-01-09 |
| IMAGESVR PACS (K082808) | Jaguar Technology Limited | 2009-01-09 |
| SONY UP-DF750 DIGITAL FILM IMAGER (K083522) | Sony Electronics, Inc. | 2009-01-09 |
| ELLEX INNOVATIVE IMAGING EYE CUBED V4 (K083061) | Ellex, Inc. | 2009-01-09 |
| LUBRICANO-ULTRASOUND (K083358) | Farco Pharma GmbH | 2009-01-09 |
| KUBTEC XPERT 20 (K083510) | Kub Technologies, Inc. | 2009-01-08 |
| WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER (K083274) | Biocompatibles, Inc. | 2009-01-08 |
| CARDIO VUE QUANTITATIVE ANALYSIS (CVQ) (K082526) | Mri Cardiac Services, Incorporated | 2009-01-05 |
| CARESTREAM PACS, MODEL CARESTREAM PACS VII (K083673) | Carestream Health, Inc. | 2008-12-30 |
| IKOENGELO, VERSION 2 (K083591) | Ikoetech, LLC | 2008-12-29 |
| RSVP HALF SPHERE PHANTOM, MODEL DDP010 (K082909) | The Phantom Laboratory, Inc. | 2008-12-23 |
| TT1 GENERAL PURPOSE COIL (K083434) | Tursiop Technologies, LLC | 2008-12-23 |
| IMAGE-ARENA APPLICATIONS (K083348) | Tomtec Imaging Systems GmbH | 2008-12-23 |
| SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER (K081148) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-12-22 |
| CT BRAIN PERFUSION FOR ZIOSTATION (K083084) | Ziosoft, Inc. | 2008-12-19 |
| ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM (K083254) | Aloka Co., Ltd. | 2008-12-19 |
| PHILIPS MODEL MX 16 SLICE CT SYSTEM (K083498) | Philips Medical Systems (Cleveland), Inc. | 2008-12-17 |
| STASYS MOTION CORRECTION SOFTWARE (K082904) | Digirad Corp. | 2008-12-17 |
| PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION (K083555) | Emsoma Co., Ltd. | 2008-12-16 |
| NEURO III-SV (K083137) | Imris, Inc. | 2008-12-16 |
| DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC (K082224) | Shimadzu Medical Systems | 2008-12-15 |
| DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM (K083505) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-12-12 |
| VISAGE PACS, VERSION 6.0/CS 3.1 (K082269) | Visage Imaging, Inc. | 2008-12-12 |
| MODEL TSX-301B AQUILION CT SYSTEM (K083282) | Toshiba America Medical Systems, In.C | 2008-12-12 |
| GE DISCOVERY NM/CT 570C (K083504) | Ge Medical Systems F.I. Haifa | 2008-12-12 |
| IBA PROTON THERAPY SYSTEM- PROTEUS 235 (K082416) | Ion Beam Applications S.A. | 2008-12-12 |
| MRI-PLAQUE VIEW, VERSION 1.1.2003 (K082607) | Vpdiagnostics, Inc. | 2008-12-05 |
| HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F (K081073) | Pausch, LLC | 2008-12-05 |
| PRAGER SHELL (K082893) | Esi, Inc. | 2008-12-05 |
| MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (K083029) | Ralco S.R.L. | 2008-12-05 |
| ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) (K083086) | Hitachi Medical Systems America, Inc. | 2008-12-05 |
| VIATRONIX V3D-CARDIAC, REVISION 1.0 (K083293) | Viatronix, Inc. | 2008-12-05 |
| SUINSA DIAGNOSTIC X-RAY SYSTEM (K083109) | Suinsa | 2008-12-04 |
| VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 (K082456) | Verathon Incorporated | 2008-12-01 |
| QV-9000 UNIVERSAL SYSTEM (K083181) | Quantum Medical Imaging, LLC | 2008-11-26 |
| CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM (K082432) | Bioptics, Inc. | 2008-11-21 |
| 16CH AI BREAST COILS 1.5 T AND 3 T (K083255) | Rapid Biomedical GmbH | 2008-11-21 |
| NEORAY DR 2520 DIGITAL IMAGING SYSTEM (K083048) | Portavision Medical, LLC | 2008-11-21 |
| GE LUNAR FEMUR STRENGTH SOFTWARE (K072664) | Ge Medical Systems Ultrasound and Primary Care Dia | 2008-11-21 |
| VIZTEK DR, MODELS: DR1000, DR3000, DR4000 (K082604) | Viztek, Inc. | 2008-11-21 |
| NORDICICE SOFTWARE (K082441) | Nordicimaginglab AS | 2008-11-21 |
| SYMBIA, VERSION 4.0 (K082506) | Siemens Medical Solutions USA, Inc. | 2008-11-21 |
| INFINITT XELIS (K082990) | Infinitt Co., Ltd. | 2008-11-20 |
| SNTRYPACS (K082240) | Qstar Technologies, Inc. | 2008-11-20 |
| CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 (K082628) | Circle Cardiovascular Imaging, Inc. | 2008-11-20 |
| STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 (K082773) | Standard Imaging, Inc. | 2008-11-19 |
| IC-PRO SYSTEM, VERSION 3.1.0.4 (K082907) | Paieon, Inc. | 2008-11-18 |
| VIDA PULMONARY WORKSTATION 2 (PW2) (K083227) | Vida Diagnostics, Inc. | 2008-11-18 |
| DIGITAL RADIOGRAPHY, FLEXDR C30 (K082347) | Konica Minolta Technoproduct Co., Ltd. | 2008-11-18 |
| STEREO NAVIGATOR ACCESSORY, STN-1000 (K082354) | Naviscan Pet Systems | 2008-11-18 |
| C-QUEST (K082581) | Medx, Inc. | 2008-11-14 |
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |
| CENTRICITY PACS WEB DIAGNOSTIC (K083018) | Ge Healthcare Dynamic Imaging Solutions | 2008-11-14 |
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K082142) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (K083035) | Sicel Technologies, Inc. | 2008-11-13 |
| COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS) (K082606) | D3 Radiation Planning | 2008-11-10 |