meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2003-03-25

Clearances · page 88 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030317 MODEL 1300GE-64: PEDIATRIC POSITIONER Midwest Rf, LLC MOS Class II 2003-03-25
K030610 POD PAC-20M Portable Ophthalmic Devices, Inc. IYO Class II 2003-03-21
K024012 OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems JAA Class II 2003-03-20
K024183 ALTON PT STEPPER Alton Design, LLC KXK Class II 2003-03-17
K030609 MODULEAF Mrc Systems GmbH IXI Class II 2003-03-17
K030455 BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2003-03-13
K030745 GAMMAMED 212 AND 232 SOURCE ASSEMBLY Varian Medical Systems KXK Class II 2003-03-12
K024085 CCD CAMERA, MODEL PKP-06000-000 Perkins Electronics Co. IZJ Class II 2003-03-11
K010705 OPTIDOS Ptw-New York Corp. KXK Class II 2003-03-11
K024284 VICTOREEN THEBES II, MODEL 7020 Syncor Radiation Management IYE Class II 2003-03-11
K024159 STRYKERWARE SYSTEM Stryker Endoscopy LLZ Class II 2003-03-10
K030242 FYRELINK Mpacs, LLC LLZ Class II 2003-03-10
K030420 LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM GE Medical Systems JAK Class II 2003-03-10
K030520 INTERA FAMILY Philips Medical Systems North America Co. LNH Class II 2003-03-06
K030495 3.0T TORSO PHASED ARRAY COIL Ge Medical Systems, Inc. MOS Class II 2003-03-05
K024171 VIDAR BONE TRACK SYSTEM SOFTWARE Vidar Systems Corp. JAK Class II 2003-03-04
K030042 PREMIER III PHASED ARRAY CTL SPINE COIL Usa Instruments, Inc. MOS Class II 2003-02-24
K024149 PRIMELUNG Accuimage Diagnostics Corp. JAK Class II 2003-02-21
K021945 PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) Planmed OY IZH Class II 2003-02-21
K023982 LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL Usa Instruments, Inc. MOS Class II 2003-02-21
K023929 MAGNETIC RESONANCE DIAGNOSTIC DEVICE Advanced Imaging Research, Inc. MOS Class II 2003-02-21
K023848 MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: Igc-Medical Advances, Inc. MOS Class II 2003-02-14
K024147 PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM Varian Medical Systems, Inc. MQB Class II 2003-02-12
K023801 FILM PROCESSOR, MODEL LIFE RAY PRO 1000 S.A.I.E.P. S.R.L. IXW Class II 2003-02-12
K023825 FILM PROCESSOR, MODEL LIFE RAY PRO 2500 S.A.I.E.P. S.R.L. IXW Class II 2003-02-12
K023255 TECHNOS MP, MODEL AU6 Biosound Esaote, Inc. IYN Class II 2003-02-11
K030199 GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM General Electric Co. KPS Class II 2003-02-11
K023785 LUNG NODULE ASSESSMENT AND COMPARISON OPTION Philips Medical Systems (Cleveland), Inc. JAK Class II 2003-02-10
K030223 SONOCALC Sonometric Health, LLC LLZ Class II 2003-02-06
K022877 OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM Vision Chips, Inc. LLZ Class II 2003-02-05
K030085 CARDIUS-1 AND CARDIS-2 Digirad Corp. KPS Class II 2003-02-05
K023988 GE DISCOVERY LS SYSTEM GE Medical Systems KPS Class II 2003-02-04
K024187 SPIRIT III TOTALSENSE CARDIAC COIL Usa Instruments, Inc. MOS Class II 2003-02-04
K024066 INFINION SOFTWARE FEATURES Philips Medical Systems (Cleveland), Inc. LNH Class II 2003-02-04
K022863 HTS COIL Jockey Club Mri Engineering Center MOS Class II 2003-02-04
K024042 PANORAMA ENHANCEMENTS Philips Medical Systems, Inc. LNH Class II 2003-02-04
K024188 UP-DF500 FILMSTATION DIGITAL FILM IMAGER Sony Medical Systems LMC Class II 2003-02-04
K022961 RTDOSEPLAN Math Resolutions, LLC MUJ Class II 2003-01-31
K022326 RADIOMED MARKER Radiomed Corporation JAK Class II 2003-01-31
K030191 TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM Teratech Corp. IYN Class II 2003-01-29
K023686 AURORA MR-GUIDED INTERVENTIONAL SYSTEM Aurora Imaging Technology, Inc. LNH Class II 2003-01-29
K023512 PICUS ULTRASOUND IMAGING SYSTEMS Pie Medical IYN Class II 2003-01-24
K023970 QUANTITATIVE VASCULAR ANGIOGRAPHY - CMS Medis Medical Imaging Systems BV IZI Class II 2003-01-24
K024028 SHARP VIEW IMAGE ENHANCEMENT SYSTEM Context Vision AB LLZ Class II 2003-01-24
K024103 IVUS PLUS Indec Systems, Inc. LLZ Class II 2003-01-24
K023650 INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL Usa Instruments, Inc. MOS Class II 2003-01-24
K023613 AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 Alphatek Corp. IXW Class II 2003-01-23
K030064 ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY Sonosite,Inc. ITX Class II 2003-01-22
K024236 ULTRASOUND SCANNER, TYPE 2400 B-K Medical A/S IYN Class II 2003-01-17
K023533 BARCO MEDIS 5MP2 AURA Barco N.V. LLZ Class II 2003-01-17
K023519 RADIONICS VARILINK 2 Radionics, A Division of Tyco Healthcare Group LP IYE Class II 2003-01-16
K024200 INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) Ge Medical Systems, Inc. OWB Class II 2003-01-16
K024137 JUPITER PROCESSING AND REVIEW WORKSTATION Ge Medical Systems, Inc. LLZ Class II 2003-01-15
K023449 NON-INVASIVE PATIENT FIXATION SYSTEM Stryker Leibinger IYE Class II 2003-01-13
K024114 A-SCAN 100 Ophthalmic Technologies, Inc. IYO Class II 2003-01-10
K024209 QWH-250-PAN WRIST ARRAY COIL Mri Devices Corp. MOS Class II 2003-01-09
K024352 HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM Mri Devices Corp. MOS Class II 2003-01-09
K024354 PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS Mri Devices Corp. MOS Class II 2003-01-09
K023460 PACSPLUS Medical Standard Co., Ltd. LLZ Class II 2003-01-09
K023864 PERFORMA STEREO Instrumentarium Corp. Imaging Division IZH Class II 2003-01-09
K023394 UNISIGHT SYSTEM WITH UNIGATE Electronic Business Machine Co., Ltd. (Ebm) LLZ Class II 2003-01-07
K024208 OBC-250-PAN BREAST ARRAY COIL Mri Devices Corp. MOS Class II 2003-01-07
K021338 ACCULEAF Direx Systems Corp. IYE Class II 2003-01-07
K023467 HCP DICOM NET Softlink International, Inc. LLZ Class II 2003-01-07
K023476 UNIPACS WORKSTATION Universal Pacs, Inc. LLZ Class II 2003-01-07
K023373 ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 Gvi Technology Partners IYX Class I 2003-01-03
K021987 PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY S&S Par Scientific IXI Class II 2002-12-27
K022517 USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY U-Systems, Inc. IYN Class II 2002-12-24
K023877 Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN Philips Ultrasound, Inc. LLZ Class II 2002-12-23
K023246 AMALGA PACS Global Care Solutions, S.A. LLZ Class II 2002-12-23
K023339 IMAGETILE Barco N.V. LLZ Class II 2002-12-23
K023341 CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. LLZ Class II 2002-12-23
K023340 CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. LLZ Class II 2002-12-23
K023322 CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. LLZ Class II 2002-12-23
K023293 MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 Med-Tec,Inc. IYE Class II 2002-12-23
K023247 CHAMPION 5000 PERIPHERAL VASCULAR COIL Usa Instruments, Inc. MOS Class II 2002-12-23
K023936 MODIFICATION TO MEDIPRIME Algotec Systems, Ltd. LLZ Class II 2002-12-20
K023554 DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE Ge Lunar Corp. KGI Class II 2002-12-20
K023137 PHILIPS EASYVISION WORKSTATION RELEASE 6 Philips Medical Systems North America Co. LLZ Class II 2002-12-19
K023996 ALOKA SSD-3500 ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2002-12-18
K020683 ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 Ati Medical, Inc. KXK Class II 2002-12-17
K023084 MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL Medical Advances, Inc. MOS Class II 2002-12-16
K022773 BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco N.V. LLZ Class II 2002-12-13
K023229 S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE American Mammographics, Inc. IZH Class II 2002-12-13
K023957 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) Sonosite,Inc. IYN Class II 2002-12-12
K022928 HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS Hudson Diagnostic Imaging, LLC IYO Class II 2002-12-11
K023932 GE PHOTON ENERGY RECOVERY (PER) OPTION Ge Medical Systems F.I. Haifa KPS Class II 2002-12-11
K023242 I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE Implant Sciences Corp. KXK Class II 2002-12-04
K022911 MODEL AMI1200 C-ARM Integrity Practice Management, Inc. JAA Class II 2002-12-02
K023390 MY BREAST FRIEND, BREAST SELF-EXAM PAD Mbf Sales, LLC IXH Class I 2002-11-26
K023178 INNOVA 4100 Ge Medical Systems, Inc. OWB Class II 2002-11-26
K023768 ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 Cti Pet Systems, Inc. KPS Class II 2002-11-25
K022970 AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 Amicas, Inc. LLZ Class II 2002-11-22
K023110 CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 Digirad Corp. KPS Class II 2002-11-22
K022899 PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 Philips Medical Systems North America Co. JAA Class II 2002-11-22
K023687 SOMATOM EMOTION 6 CT SYSTEMS Siemens Medical Systems, Inc. JAK Class II 2002-11-22
K023760 CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B Toshiba America Medical Systems, In.C JAK Class II 2002-11-22
K023750 CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G Canon USA, Inc. MQB Class II 2002-11-22
K023772 KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Acuson Corp. LLZ Class II 2002-11-22
K023636 BLOCKING TRAY Southeastern Radiation Products, Inc. IYE Class II 2002-11-22

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