| AQUILION ONE VISION, V4.90 (K122109) | Toshiba America Medical Systems, In.C | 2012-09-21 |
| ASPIRE HD PLUS, ASPIRE HD-S (K121674) | Fujifilm Medical System U.S.A., Inc. | 2012-09-21 |
| VOLUSON E6/E8/E8EXPERT/E10 (K122327) | GE Healthcare | 2012-09-21 |
| E-CUBE 7 (K121729) | Alpinion Medical Systems Co., Ltd. | 2012-09-20 |
| 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT (K121676) | Ge Medical Systems, LLC | 2012-09-20 |
| ORTHOCAD SOFTWARE OPTION (K120288) | Esaote, S.p.A. | 2012-09-19 |
| VITASCAN LT SCANMASTER (K121689) | Vitacon Medical, Inc. | 2012-09-19 |
| DX-D FULL LEG FULL SPINE (K122119) | Afga Healthcare N.V. | 2012-09-13 |
| VIRTUOST (K113725) | O.N. Diagnostics | 2012-09-13 |
| AIM (K121479) | Inneroptic Technology, Inc. | 2012-09-13 |
| VIAMO SSA-640A V4.0 (K122491) | Toshibamedical Systems Corporation | 2012-09-13 |
| GSI VIEWER WITH VUE OPTION (K121827) | GE Medical Systems SCS | 2012-09-13 |
| PATIENT POSITIONING SYSTEM (K122413) | Forte Automation Systems, Inc. | 2012-09-13 |
| CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE (K122427) | Carestream Dental, LLC | 2012-09-12 |
| AYCAN MOBILE (K122260) | Aycan Digitalsysteme GmbH | 2012-09-12 |
| SOMATOM DEFINITION (K122471) | Siemens Medical Systems, Inc. | 2012-09-11 |
| VOLUSON P6, VOLUSON P8 (K122387) | GE Healthcare | 2012-09-11 |
| C2-9-D ULTRASOUND TRANSDUCER (K122515) | GE Healthcare | 2012-09-11 |
| VITREAVIEW (K122136) | Vital Images, Inc. | 2012-09-07 |
| DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA (K121983) | Benq Medical Technology Corpation | 2012-09-07 |
| MR VESSELLQ XPRESS (K122164) | GE Medical Systems SCS | 2012-09-07 |
| UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM (K122583) | Samsung Medison Co., Ltd. | 2012-09-05 |
| THIXO-GEL ULTRASOUND SPRAY (K121311) | Cloverline International Pharma Services GmbH | 2012-08-30 |
| PROTURA COUCH SOFTWARE (K122201) | Med-Tec, Inc. D/B/A Civco Medical Solutions | 2012-08-30 |
| TOMOTHERAPY TREATMENT SYSTEM (K121934) | Accuray Incorporated | 2012-08-29 |
| FDR GO FLEX (K120629) | Fujifilm Medical System U.S.A., Inc. | 2012-08-28 |
| KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) (K120246) | Carestream Health, Inc. | 2012-08-28 |
| AIXPLORER (K112255) | Supersonic Imagine | 2012-08-28 |
| PAX-UNI3D, PHT-7500 (K121400) | VATECH Co., Ltd. | 2012-08-28 |
| AIXPLORER (K121329) | Supersonic Imagine | 2012-08-24 |
| SYSTEM, X-RAY, STATIONARY (K121854) | Beijing Sinopharm Hundric Mediline Info. Tech. Co. | 2012-08-22 |
| VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM (K121063) | Ge Medical System Israel , Ltd. | 2012-08-21 |
| OCTAVE SPEEDER SPINE (K121911) | Toshiba Medical Systems Corporation, Japan | 2012-08-17 |
| VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM (K121062) | Ge Medical System Israel , Ltd. | 2012-08-17 |
| OCTAVE SPEEDER HEAD (K121910) | Toshiba Medical Systems Corporation, Japan | 2012-08-17 |
| LUNG VOLUME ANALYSIS (K113715) | Toshibamedical Systems Corporation | 2012-08-17 |
| DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC (K122182) | Rayence Co., Ltd. | 2012-08-16 |
| OEC 9900 ELITE (K122234) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-08-16 |
| APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM (K121422) | Toshiba Medical Systems Coporation, Japan | 2012-08-16 |
| DX-D IMAGING PACKAGE (K121095) | Agfa Healthcare N.V. | 2012-08-16 |
| BIOJET (K122329) | Jet Soft Srl | 2012-08-16 |
| EXINI (K122205) | Exini Diagnostics AB | 2012-08-15 |
| EXACTRAC X-RAY X-RAY (K120789) | Brainlab AG | 2012-08-14 |
| MULTIX FUSION (K121513) | Siemens Medical Solution | 2012-08-10 |
| IMRIS ONCOLOGY PACKAGE (K121997) | Imris, Inc. | 2012-08-10 |
| ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT (K113210) | Isoaid, LLC | 2012-08-10 |
| BIOPSY DIGIT S BIOPSY SL (K113607) | Giotto USA, LLC | 2012-08-10 |
| G-SCAN BRIO (K122006) | Esaote, S.p.A. | 2012-08-06 |
| 8MP COLOR LCD MONITOR, REDIFORCE RX840 (K120451) | Eizo Nanao Corporation | 2012-08-03 |
| IDENTIFY (K112692) | Humediq GmbH | 2012-08-03 |
| SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS (K121867) | Chison Medical Imaging Co., Ltd. | 2012-08-02 |
| MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE (K120734) | Microsoft Corp. | 2012-08-02 |
| DRAGON LW (K121410) | Sedecal., Sa. | 2012-08-02 |
| DYNAPBV BODY SOFTWARE (K121292) | Siemens Medical Solutions USA, Inc. | 2012-07-30 |
| SENTINEL (K120668) | C-Rad Positioning AB | 2012-07-30 |
| CS-SERIES-FP WITH 3030+OPTION (K121293) | Omega Medical Imaging, LLC | 2012-07-26 |
| MOBILE C-ARM (K121303) | Canon Inc. -Medical Equipment Group | 2012-07-26 |
| AQUILION RXL (K121553) | Toshibamedical Systems Corporation | 2012-07-26 |
| E-CUBE 15 (K121888) | Alpinion Medical Systems Co., Ltd. | 2012-07-26 |
| NERVEVISION SOFTWARE SYSTEMS (K121075) | 3D Imaging Partners, Inc. | 2012-07-26 |
| E-CUBE INNO (K121937) | Alpinion Medical Systems Co., Ltd. | 2012-07-26 |
| CLARISCT (K120753) | Icrco, Inc. | 2012-07-26 |
| GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER (K120993) | Varian Medical Systems, Inc. | 2012-07-26 |
| NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER (K121195) | Ninepoint Medical, Inc. | 2012-07-25 |
| NIO 5MP (K121788) | Barco N.V. | 2012-07-23 |
| Z6 DIAGNOSTIC ULTRASOUND SYSTEM (K122010) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-07-20 |
| VERSAVUE ENTERPRISE SUITE (K121517) | Icad, Inc. | 2012-07-20 |
| CR 10-X DIGITIZER (K121948) | Agfa Healthcare N.V. | 2012-07-20 |
| CFR QUANT (K113754) | University of Texas Medical School AT Houston | 2012-07-19 |
| 3MP COLOR LCD MONITOR, RADIFORCE RX340 (K113562) | Eizo Nanao Corporation | 2012-07-16 |
| MAGNETOM SPECTRA (K121160) | Siemens Medical Solutions USA, Inc. | 2012-07-16 |
| MYRIAN 1.11 (K113620) | Intrasense | 2012-07-12 |
| MINICAT (K113421) | Xoran Technologies, Inc. | 2012-07-11 |
| LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM (K121838) | Liebel-Flarsheim | 2012-07-11 |
| DIRECTPATH (K121449) | Cybernet Systems Co., Ltd. | 2012-07-10 |
| V5MS TRANSDUCER (K121807) | Siemens Medical Solutions USA, Inc. | 2012-07-10 |
| S-SCAN (K121650) | Esaote, S.p.A. | 2012-07-09 |
| THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV (K120305) | Thinking Systems Corp. | 2012-07-09 |
| SYNAPSE 3D CARDIAC TOOLS (K120636) | Fujifilm Medical System U.S.A., Inc. | 2012-07-05 |
| CARDIOPACS (K120514) | Lumedx | 2012-07-05 |
| SIMPLANT GO (K120733) | Materialise Dental NV | 2012-07-05 |
| ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY (K121448) | Elekta Inc. D/B/A Nucletron Corporation | 2012-07-02 |
| EXACTRAC ROBOTICS NOVALIS ROBOTICS (K120520) | Brainlab AG | 2012-06-29 |
| ARTISTETM SOLUTION WITH SYS VCIO (K121295) | Siemens Medical Solutions USA, Inc. | 2012-06-27 |
| QUANTRA (K120472) | Hologic, Inc. | 2012-06-22 |
| APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM (K121577) | Toshiba Medical Systems Corporation, Japan | 2012-06-22 |
| SHEATHES ULTRASOND GEL (K112827) | Sheathing Technologies, Inc. | 2012-06-22 |
| ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM (K121646) | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2012-06-22 |
| SYNGO.MR NEUROLOGY (K121459) | Siemens Medical Solutions USA, Inc. | 2012-06-22 |
| ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM (K121699) | Siemens Medical Solutions USA, Inc. | 2012-06-22 |
| QFIX RADIOTHERAPY CHAIR (K120916) | Wfr/Aquaplast Corp. | 2012-06-20 |
| BODYFIX SYSTEM (K121530) | Medical Intelligence Medizintechnik GmbH | 2012-06-20 |
| CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL (K120910) | GE Medical Systems SCS | 2012-06-18 |
| READY VIEW (K113456) | Ge Healthcare (Ge Medical Systems Scs) | 2012-06-15 |
| DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM (K113613) | Shantou Institute of Ultrasonic Instuments | 2012-06-15 |
| 1.5T 16CH FLEX SPEEDER LARGE (K121362) | Neocoil, LLC | 2012-06-15 |
| FUSION FLAT PANEL (K113449) | Icrco, Inc. | 2012-06-14 |
| SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS (K120648) | Fujifilm Medical System U.S.A., Inc. | 2012-06-14 |
| CHISON DIAGNOSTIC ULTRASOUND SYSTEM (K120801) | Chison Medical Imaging Co., Ltd. | 2012-06-14 |
| SONIXGPS NEEDLE SENSOR (K111818) | Ultrasonix Medical Corporation | 2012-06-13 |