| MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM (K012239) | Hitachi Medical Corp. | 2001-08-10 |
| BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 (K012369) | Atys Medical | 2001-08-10 |
| CYBERKNIFE SYSTEM (K011024) | Accuray, Inc. | 2001-08-10 |
| HISPEED X/I SMART GANTRY OPTION (K012385) | Ge Medical Systems, Inc. | 2001-08-10 |
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM (K012389) | Ge Medical Systems, Inc. | 2001-08-10 |
| KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS (K012155) | Eastman Kodak Company | 2001-08-10 |
| LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (K012373) | Ferrania S.P.A. | 2001-08-09 |
| CT COLONOGRAPHY/NAVIGATOR2 (K012313) | Ge Medical Systems, Inc. | 2001-08-07 |
| MUSCLE IMAGING SYSTEM (MIS) (K011416) | Millennium Magnetic Imaging, Inc. | 2001-08-06 |
| ADVANCED HIP ASSESSMENT SOFTWARE (K011917) | Ge Lunar Corp. | 2001-08-03 |
| 1.5T INFINITY TWINSPEED MR SYSTEM (K012200) | GE Medical Systems | 2001-08-03 |
| IN SPACE 3D (K011447) | Siemens Medical Solutions USA, Inc. | 2001-08-03 |
| MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES (K012099) | Totoku Electric Co., Ltd. | 2001-07-31 |
| EFILM WORKSTATION (K012211) | Efilm Medical, Inc. | 2001-07-31 |
| QCU ANALYTICAL SOFTWARE PACKAGE (K011582) | Medis Medical Imaging Systems BV | 2001-07-31 |
| EXAC TRAC 2.0 (NOVALIS BODY MODULE) (K003285) | Brainlab AG | 2001-07-31 |
| RF-IVD WIRELESS DOSIMETER-MODEL 1133 (K011332) | Sun Nuclear Corp. | 2001-07-26 |
| TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES (K012191) | Teratech Corp. | 2001-07-26 |
| NORTHEAST PROTON THERAPY CENTER (K983332) | Massachusetts General Hospital | 2001-07-20 |
| INFINION ENHANCEMENT PACKAGE (K011296) | Philips Medical Systems (Cleveland), Inc. | 2001-07-19 |
| AMERITEK BRACHYTHERAPY TEMPLATE (K011581) | Amertek Medical, Inc. | 2001-07-17 |
| INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S (K011155) | Ibt, Inc. | 2001-07-12 |
| PROTON THERAPY SYSTEM (K983024) | Ion Beam Applications S.A. | 2001-07-12 |
| VOXAR VC, MODEL 1.0 (K012072) | Voxar Limited | 2001-07-12 |
| VARISEED 7.0 (K012017) | Varian Medical Systems | 2001-07-12 |
| VORTEX (K012097) | Ultravisual Medical Systems | 2001-07-12 |
| IMMOBILIZATION SYSTEM FOR ENT (K003779) | Arplay Medical S.A. | 2001-07-12 |
| MODIFIED M-IV MAMMOGRAPHY SYSTEM (K011987) | Lorad, A Hologic Co. | 2001-07-11 |
| TELEPAX (K011173) | Imed Systems & Consulting, LLC | 2001-07-11 |
| ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 (K011205) | Isoaid | 2001-07-10 |
| UROLOGIC (K011311) | Pck Electronic Industry and Trade Co, Ltd. | 2001-07-10 |
| SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC (K011141) | Shimadzu Corp. | 2001-07-03 |
| SMART RAD (K003438) | Cmt Medical Technologies, Ltd. | 2001-07-03 |
| CT/MASTER, VERSION 1.0 (K011180) | Columbia Scientific, Inc. | 2001-06-27 |
| CYPRESS SYSTEM (K010950) | Acuson Corp. | 2001-06-27 |
| SYNGO MULTIMODALITY WORKSTATION (K010938) | Siemens Medical Solutions USA, Inc. | 2001-06-26 |
| BRACHYSEED PD-103 MODELS #PD1 (K011119) | Draximage, Inc. | 2001-06-25 |
| THIN FILM DRESSING FOR ULTRASOUND EXAM (K011284) | Martin E. Wendelken | 2001-06-20 |
| Q-RAD RADIOGRAPHIC SYSTEM (K011486) | Quantum Medical Imaging, LLC | 2001-06-20 |
| PTW DOSIMETRY DIODE, T60008 (K010916) | Ptw-New York Corp. | 2001-06-20 |
| ZIEHM VISION (K011292) | Ziehm International, Inc. | 2001-06-20 |
| QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) (K011572) | Digirad Corp. | 2001-06-15 |
| MX8000 V5.0 CT SYSTEM (K010817) | Philips Medical Systems (Cleveland), Inc. | 2001-06-15 |
| MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM (K011095) | Iodp SA | 2001-06-13 |
| CARDIOCAM MODEL 9CSY0799 (K011611) | Danish Diagnostic Development A/S | 2001-06-08 |
| CARDIAC VIEW, MODEL 2001 (K010802) | Magna Lab, Inc. | 2001-06-08 |
| ULTRASOUND SCANNER, TYPE 2102 (K011417) | B-K Medical A/S | 2001-06-08 |
| LIFEJET PRINTER 400 (K011617) | Ferrania S.P.A. Stabilimento DI Ferrania | 2001-06-08 |
| BREAST-BOARD (MULTIPLE) (K003778) | Arplay Medical S.A. | 2001-06-08 |
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |
| XSCAN32 TELERADIOLOGY SOFTWARE (K002911) | Radiographic Digital Imaging, Inc. | 2001-06-07 |
| QED DIODE DETECTORS, MODELS 1112-1116 (K011466) | Sun Nuclear Corp. | 2001-06-06 |
| PINNACLE MAGNETIC RESONANCE IMAGING SCANNER (K011485) | Fonar Corp. | 2001-06-06 |
| HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM (K010682) | Mds Nordion | 2001-06-05 |
| EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM (K011252) | Hitachi Medical Corp. | 2001-05-30 |
| MARK 9000 PHASED ARRAY SHOULDER COIL (K010946) | Usa Instruments, Inc. | 2001-05-30 |
| BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS (K010773) | Siemens Medical Solutions USA, Inc. | 2001-05-30 |
| PROGNOST ES, MODEL 0302 0000 (K011290) | Xmar Corp. | 2001-05-30 |
| MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) (K011111) | Modular X-Ray Devices | 2001-05-30 |
| KFA-127 KNEE, FOOT AND ANKLE ARRAY (K003505) | Mri Devices Corp. | 2001-05-25 |
| GOODNET (K010763) | Goodman Co., Ltd. | 2001-05-25 |
| ULTRAGUIDE MR-GUIDE 3000 (K011418) | Ultraguide , Ltd. | 2001-05-24 |
| DCM 1.0 (K011246) | Mds Nordion | 2001-05-23 |
| ALOKA SSD-5500 WITH KI AND A-SMA (K011457) | Aloka Co., Ltd. | 2001-05-23 |
| VHF ULTRASONIC ARC-SCAN SYSTEM (K003890) | Ultralink, LLC | 2001-05-22 |
| CARDIAC VIEW, MODEL 2001 (K010513) | Magna-Lab, Inc. | 2001-05-21 |
| GE LOGIQ 9, MODEL 2188900-X (K011188) | GE Medical Systems | 2001-05-18 |
| RADCALC, MODEL V.4.0 (K010464) | Lifeline Software, Inc. | 2001-05-17 |
| E-Z EM PERCUPUMP 2001 CT INJECTOR (K011160) | E-Z-Em, Inc. | 2001-05-16 |
| MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL (K010730) | Usa Instruments, Inc. | 2001-05-16 |
| OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM (K011314) | Aloka Co., Ltd. | 2001-05-15 |
| SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 (K011315) | Aloka Co., Ltd. | 2001-05-15 |
| PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 (K010472) | Thomson & Nielsen Electronics, Ltd. | 2001-05-08 |
| AQUARIUS WORKSTATION (K011142) | Terarecon,Inc. | 2001-05-08 |
| BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION (K010691) | Philips Medical Systems (Cleveland), Inc. | 2001-05-08 |
| SIMPLICT (K010813) | Neorad AS | 2001-05-07 |
| IVD (IN VIVO DOSIMETER), MODEL 1131 (K010449) | Sun Nuclear Corp. | 2001-05-04 |
| HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY (K011224) | Advanced Technology Laboratories, Inc. | 2001-05-04 |
| TETRAD TC-C3-ACP (K002193) | Tetrad Corp. | 2001-05-04 |
| ECLIPSE 6.5 (K010975) | Varian Medical Systems, Inc. | 2001-05-02 |
| DRYSTAR 4500 PRINTER, MODEL 4500 (K010275) | Agfa Medical Imaging | 2001-04-27 |
| CEDARS-SINAI BPGS AND MOCO (K010509) | Smv America | 2001-04-27 |
| THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 (K010283) | Theragenics Corp. | 2001-04-26 |
| CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 (K010417) | Nuclear Assoc., Div. Inovision LP | 2001-04-26 |
| MODIFICATION TO MIRAGE (K010726) | Segami Corp., Inc. | 2001-04-26 |
| MEDIFACE PACS (K010259) | Mediface Co., Ltd. | 2001-04-26 |
| GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 (K003206) | Proxima Therapeutics, Inc. | 2001-04-25 |
| DOSIMETRY CHECK (K010225) | Math Resolutions, LLC | 2001-04-24 |
| TRAY ADAPTERS, MULTIPLE (K010174) | Arplay Medical S.A. | 2001-04-18 |
| LEAD BLOCKS (K010172) | Arplay Medical S.A. | 2001-04-18 |
| U04 (K010942) | Siemens Medical Solutions USA, Inc. | 2001-04-12 |
| FIESTA IMAGING OPTION (K002997) | GE Medical Systems | 2001-04-11 |
| ECHOSEED/IODINE-125 SEEDS, MODEL 6733 (K010821) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 2001-04-11 |
| PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 (K010784) | Nucletron Corp. | 2001-04-10 |
| BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 (K010570) | Mri Devices Corp. | 2001-04-09 |
| TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE (K010883) | Teratech Corp. | 2001-04-06 |
| EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 (K010129) | Toshiba America Medical Systems, In.C | 2001-04-05 |
| MODEL 455GE PHASED ARRAY WRIST COIL (K010074) | Medical Advances, Inc. | 2001-04-03 |
| THINKINGNET (K010271) | Thinking Systems Corp. | 2001-04-03 |
| MAMMOGRAPH (K010792) | Digitec Medical Service Corp. | 2001-04-03 |