meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2003-10-29

Clearances · page 86 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033326 PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc. JAK Class II 2003-10-29
K032996 ELEKTA SYNERGY SYSTEM Elekta Oncology Systems, Ltd. IYE Class II 2003-10-23
K032576 BIOPSY BREAST COIL, MODEL BBC Mri Devices Corp. MOS Class II 2003-10-23
K033139 GE MARLIN ULTRASOUND General Electric Co. IYN Class II 2003-10-23
K032477 GE LOGIQ BOOK General Electric Co. IYN Class II 2003-10-22
K033254 FORTE GAMMA CAMERA SYSTEM Adac Laboratories KPS Class II 2003-10-22
K032974 GE LOGIQ 5 PRO OR EXPERT General Electric Co. IYN Class II 2003-10-21
K031066 VIEWMATE ULTRASOUND IMAGING SYSTEM Ep Medsystems IYN Class II 2003-10-17
K033196 SONOLINE ANTARES WITH CLARIFY VE Siemens Medical Solutions USA, Inc. IYN Class II 2003-10-16
K032456 PROWESS Prowess, Inc. MUJ Class II 2003-10-16
K032428 MAGNETOM AVANTO MR SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2003-10-16
K032546 HOLOGIC DR IMAGEPRO Hologic, Inc. LLZ Class II 2003-10-16
K032533 INTELEPACS Intelerad Medical Systems, Inc. LLZ Class II 2003-10-16
K033244 DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION Ge Medical Systems, Inc. OWB Class II 2003-10-16
K032186 AUTOALIGN Cortechs Labs, Inc. LLZ Class II 2003-10-14
K032620 GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM General Electric Co. IYN Class II 2003-10-10
K033152 HAC-12 AND HAC-30 HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2003-10-10
K032956 ACCUSONIC A-SCAN MODEL, 24-4000 Accutome, Inc. IYO Class II 2003-10-10
K033168 GE 0.2T SIGNA PROFILE/I MR SYSTEM General Electric Co. LNH Class II 2003-10-10
K032924 RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 Volume Interactions Pte, Ltd. LLZ Class II 2003-10-10
K033151 KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL Mri Devices Corp. MOS Class II 2003-10-10
K032654 PORT CASSETTE Orex Computed Radiography, Ltd. IXK Class II 2003-10-09
K032724 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Adac Laboratories MUJ Class II 2003-10-09
K032795 GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM Ge Medical Systems, LLC LNH Class II 2003-10-08
K032960 WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A Wide Corporation LLZ Class II 2003-10-08
K032725 MOSFET AUTOSENSE WIRELESS Thomson & Nielsen Electronics, Ltd. IYE Class II 2003-10-03
K032790 MICROMLC Siemens Medical Solutions USA, Inc. IXI Class II 2003-10-02
K031590 SECTRA ORTHOPEDIC PACKAGE Sectra-Imtec AB LLZ Class II 2003-10-02
K032243 MINICAT DENTOCAT Xoran Technologies, Inc. JAK Class II 2003-10-02
K031567 3D INVIVO BY CSIST Chung-Shan Institute of Science and Technology LLZ Class II 2003-10-02
K032324 ECHOENCODER Icardiogram, Incorporated LLZ Class II 2003-10-02
K032210 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM Alara, Inc. MQB Class II 2003-10-02
K032100 I-BEAM Computerized Medical Systems, Inc. IYE Class II 2003-10-02
K032875 ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM Aloka Co. Ltd USA IYO Class II 2003-09-30
K032232 AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE Hitachi Medical Systems America, Inc. LNH Class II 2003-09-29
K032633 HRK-63-8 KNEE ARRAY COIL Mri Devices Corp. MOS Class II 2003-09-25
K032550 EXOMIO, MODEL 2.0 SP1 Medcom GmbH KPQ Class II 2003-09-25
K032176 RATTAN IMACS BY RATTAN INFORMATION CORPORATION Rattan Information Corporation LLZ Class II 2003-09-25
K032248 PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 Aktina Medical Physics Corp. IYE Class II 2003-09-25
K032157 TELEMIS-MEDICAL SOLUTION Telemis S.A. LLZ Class II 2003-09-24
K032681 KONICA LASER IMAGER, MODEL DRYPRO MODEL 771 Konica Medical and Graphic Corporation LMC Class II 2003-09-24
K032678 MODIFICATION TO: AURORA Aurora Imaging Technology, Inc. LNH Class II 2003-09-24
K032635 DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 Agfa Corp. LMC Class II 2003-09-24
K032760 APAX PACS SYSTEM Tis, Inc. LLZ Class II 2003-09-17
K030821 SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5 Simuplan S.L. MUJ Class II 2003-09-17
K032618 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL Usa Instruments, Inc. MOS Class II 2003-09-12
K032541 POLESTAR N-20 Odin Medical Technologies , Ltd. LNH Class II 2003-09-12
K032538 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL Usa Instruments, Inc. MOS Class II 2003-09-12
K022156 LATEX ULTRASONIC PROBE COVER Pleasure Latex Products Sdn. Bhd. ITX Class II 2003-09-11
K032640 FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM U-Systems, Inc. IYO Class II 2003-09-11
K032638 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY Planar Systems, Inc. LLZ Class II 2003-09-11
K032280 SIREMOBIL ISO-C 3D Siemens AG IZL Class II 2003-09-10
K031815 INTERA-SENSATION FAMILY Philips Medical Systems LNH Class II 2003-09-10
K031764 ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES Siemens Medical Solutions USA, Inc. IYE Class II 2003-09-05
K032594 ONE DIMENSIONAL WATER PHANTOM, WP 1D Wellhofer Dosimetrie IYE Class II 2003-09-05
K032345 CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY Accuray, Inc. MUJ Class II 2003-09-03
K032020 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW Iiyama Corporation LLZ Class II 2003-09-02
K032022 DIGITAL IMAGER Pyramid Medical, Inc. LMA Class II 2003-09-02
K032156 ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT Wfr/Aquaplast Corp. IYE Class II 2003-09-02
K031975 IMSURE Prodigm, Inc. IYE Class II 2003-08-29
K030066 CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 Nuclear Associates KPT Class II 2003-08-29
K031634 OMNIPRO I'MRT Wellhofer Dosimetrie IYE Class II 2003-08-29
K032026 LCD MONITOR, RADIFORCE G11, G31, G51 Eizo Nanao Corporation LLZ Class II 2003-08-27
K032474 3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL Usa Instruments, Inc. MOS Class II 2003-08-25
K032415 MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL Usa Instruments, Inc. MOS Class II 2003-08-25
K032500 MODIFICARION TO WACKERS-LIU CQ SOFTWARE Eclipse Systems, Inc. KPS Class II 2003-08-25
K032503 EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. IYN Class II 2003-08-22
K032483 VIATRONIX V3D EXPLORER, REVISION 1.2 Viatronix, Inc. LLZ Class II 2003-08-22
K031637 INNOVA 3100 GE Medical Systems OWB Class II 2003-08-22
K032490 TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 Toshiba America Medical Systems, In.C LNH Class II 2003-08-21
K032090 NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 Mri Devices Corp. MOS Class II 2003-08-21
K032429 QSC-127 SHOULDER ARRAY COIL SET Mri Devices Corp. MOS Class II 2003-08-21
K032209 NOMOS CORVUS 5.0M Nomos Corp. MUJ Class II 2003-08-21
K031771 SHIMADZU COLLIMATOR R-30H Shimadzu Corp. IZX Class II 2003-08-21
K032063 PEM 2400 PET SCANNER Pem Technologies KPS Class II 2003-08-18
K032372 NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 Nucletron Corporation JAQ Class II 2003-08-15
K031816 DVNET MDV-PACS Dvnet International Technology Co., Ltd. LLZ Class II 2003-08-14
K032401 ORTHOVIEW Omsbar, Ltd. LLZ Class II 2003-08-14
K031866 MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC Med-Tec,Inc. JAI Class II 2003-08-14
K031836 PHILIPS FRESCO RELEASE 1 Philips Medical Systems North America Co. LLZ Class II 2003-08-14
K032121 MODIFICATION TO E-SCAN XQ Esaote, S.p.A. LNH Class II 2003-08-13
K031562 RAMSOFT PACS, MODEL 3.0 Ramsoft, Inc. LLZ Class II 2003-08-11
K031778 PRACTICEBUILDER 1-2-3 Erad Imagemedical Corp. LLZ Class II 2003-08-07
K031349 OTP 1.2 Nucletron Corp. MUJ Class II 2003-08-07
K031158 SWIFT 2.0, MODEL 132.001 Nucletron Corp. JAQ Class II 2003-08-07
K031779 CADSTREAM Confirma, Inc. LLZ Class II 2003-08-06
K032329 SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYN Class II 2003-08-06
K032281 SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C IYN Class II 2003-08-06
K031574 SQUEEZE-EASE MAMMOGRAPHY CUSHION S & S X-Ray Products, Inc. IZH Class II 2003-08-04
K030487 R 72 Ralco S.R.L. KPW Class II 2003-08-01
K032202 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I Planar Systems, Inc. LLZ Class II 2003-08-01
K031704 FILMLESS CLINIC Connect Imaging, Inc. LLZ Class II 2003-07-31
K032045 8 CHANNEL CARDIAC PHASED ARRAY COIL GE Medical Systems MOS Class II 2003-07-30
K032082 AURORA Aurora Imaging Technology, Inc. LNH Class II 2003-07-30
K031731 MR FIBER OPTIC ECG GATING SYSTEM Sa Instruments, Inc. LNH Class II 2003-07-30
K031991 DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS Image Analysis, Inc. KGI Class II 2003-07-30
K030962 DPX SERIES BRAVO DUO BONE DENSITOMETER Ge Lunar Corp. KGI Class II 2003-07-25
K032182 GE LOGIQ 7, MODEL 2354858 General Electric Co. IYN Class II 2003-07-25
K032174 WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A Wide Corporation LLZ Class II 2003-07-24
K031920 CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 Trans Vascular Incorporated ITX Class II 2003-07-23

14,721 clearances in the Radiology panel. Data: openFDA.