meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
24
Latest Decision
2001-02-28

Clearances · page 94 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K003762 ALI 3D TOOL MODULE FOR MEDICAL IMAGES A.L.I. Technologies, Inc. LLZ Class II 2001-02-28
K003946 SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL GE Medical Systems MOS Class II 2001-02-27
K003672 MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE Medge Platforms, Inc. IYO Class II 2001-02-22
K010140 HRH-127 HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2001-02-22
K003651 AURORA Aurora Imaging Technology, Inc. LNH Class II 2001-02-21
K010374 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 2001-02-21
K003882 NUCAMMA BI90 Is2 Research, Inc. KPS Class II 2001-02-21
K010336 ADVANTAGE WINDOWS CT/PET FUSION Ge Medical Systems, Inc. LLZ Class II 2001-02-16
K003607 ONYX-RAD TELEMEDICINE PACS Viztek, Inc. LLZ Class II 2001-02-15
K003936 PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING Tomtec Imaging Systems GmbH IYO Class II 2001-02-14
K003795 BIOLUCENT MAMMOGRAPHY CUSHION Biolucent, Inc. IZH Class II 2001-02-14
K010187 KIMAX, MODEL 1024 Medical Metrics, Inc. JAA Class II 2001-02-14
K010137 ORBITER II CCI/SPECT ORBITER II CCI/SPECT Siemens Medical Solutions USA, Inc. KPS Class II 2001-02-13
K003853 INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 Philips Medical Systems (Cleveland), Inc. LNH Class II 2001-02-13
K003514 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 Shimadzu Medical Systems IYN Class II 2001-02-12
K010304 MXR-2000 MOBILE X-RAY UNIT Irom Imaging, Inc. IZL Class II 2001-02-12
K003510 INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 Visualization Technology, Inc. LLZ Class II 2001-02-12
K003515 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 Shimadzu Medical Systems IYN Class II 2001-02-12
K003041 ULTRASOUND SCANNER TYPE 2101 B-K Medical A/S IYO Class II 2001-02-07
K003655 PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL Mri Devices Corp. MOS Class II 2001-02-02
K010057 MODIFICATION TO ARTOSCAN M Biosound Esaote, Inc. LNH Class II 2001-02-02
K003945 OPDIMA Siemens Medical Solutions USA, Inc. IZH Class II 2001-02-02
K003436 SURGI-VISION GUIDEWIRE COIL Surgi-Vision, Inc. MOS Class II 2001-02-02
K004037 X-RAY SYSTEM XR-MX Karl Storz Endoscopy JAA Class II 2001-02-02
K002429 SELECT SEED I-125 Nucletron Corp. KXK Class II 2001-02-02
K003437 ODYSSEY LX, MODEL 211320 Philips Medical Systems (Cleveland), Inc. LLZ Class II 2001-02-02
K002237 P3IMRT TM Adac Laboratories MUJ Class II 2001-02-02
K003636 PORTALVISION Varian Medical Systems, Inc. IYE Class II 2001-02-02
K010042 CT PERFUSION 2 General Electric Co. JAK Class II 2001-01-30
K003639 VITREA 2 CT PERFUSION OPTION Vital Images, Inc. JAK Class II 2001-01-23
K003573 DIFFUSION TENSOR IMAGING OPTION Ge Medical Systems, Inc. LNH Class II 2001-01-23
K003628 MAGNETOM RHAPSODY SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2001-01-23
K003459 PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW Philips Medical Systems North America, Inc. LLZ Class II 2001-01-22
K003688 VIEW READING STATION Electromed Intl., Ltd. LLZ Class II 2001-01-22
K003481 CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 Codonics, Inc. LMC Class II 2001-01-19
K003358 QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) Smv America KPS Class II 2001-01-19
K003484 NETRA WORKSTATION AND NETRAMD SOFTWARE Scimage, Inc. LLZ Class II 2001-01-19
K003453 SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS Fonar Corp. LNH Class II 2001-01-18
K003736 MRI LINE MARKER I.Z.I. Corp. JAK Class II 2001-01-18
K003479 U-SYSTEMS ULTRASOUND SYSTEM USI-2000 U-Systems, Inc. IYN Class II 2001-01-18
K003931 VIVID 7 WITH SONOPAC, MODEL FB0008XX Ge Medical Systems, Inc. IYN Class II 2001-01-18
K001097 ACTIVE ARRAY CATHETER, MODEL CS-2000 Image-Guided Neurologics, Inc. MOS Class II 2001-01-18
K003575 MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM GE Medical Systems LNI Class II 2001-01-17
K003775 PORTABLE BREAST COMPRESSION DEVICE Pem Technologies IYX Class I 2001-01-12
K003292 260 CORVUS Pie Medical IYO Class II 2001-01-05
K003330 AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) Aktina Medical Physics Corp. IYE Class II 2001-01-04
K003386 SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 Midwest Rf, LLC MOS Class II 2000-12-28
K003097 BRAIN COIL, MODEL 9800GE-64 Midwest Rf, LLC MOS Class II 2000-12-28
K003516 GYROSCAN INTERA 3.0T Philips Medical Systems North America, Inc. LNH Class II 2000-12-27
K003568 XISCAN 6000 IMAGING SYSTEM Xitec, Inc. OXO Class II 2000-12-27
K003739 ALOKA SSD-4000 Aloka Co., Ltd. IYN Class II 2000-12-27
K003230 V SCORE WITH AUTO GATE MODEL TBD Vital Images, Inc. JAK Class II 2000-12-27
K001499 PHORMAX EAGLE SCANNER SYSTEM Phormax Corp. MQB Class II 2000-12-27
K003366 MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL Igc-Medical Advances, Inc. MOS Class II 2000-12-22
K003685 MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL Medical Advances, Inc. MOS Class II 2000-12-22
K003849 GE ADVANCE NXI PET SYSTEM Ge Medical Systems, Inc. KPS Class II 2000-12-22
K003270 PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067 Nucletron Corp. JAQ Class II 2000-12-22
K003192 MAGNETIC CONCERTO Siemens Medical Solutions USA, Inc. LNH Class II 2000-12-21
K003623 INTERACTIVE REAL TIME SCANNING PACKAGE Siemens Medical Solutions USA, Inc. LNH Class II 2000-12-21
K003264 QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION Ge Medical Systems F.I. Haifa KPS Class II 2000-12-21
K000081 MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM Isotopes and Metals , Ltd. JAQ Class II 2000-12-19
K002964 NEURO II Innovative Magnetic Resonance Imaging Systems, Inc. LNH Class II 2000-12-19
K002942 PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING Philips Medical Systems North America, Inc. LLZ Class II 2000-12-19
K003656 X-POSURE SYSTEM VERSION 2 MAMMO Pronosco A/S KGI Class II 2000-12-15
K003144 MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL Medical Advances, Inc. MOS Class II 2000-12-13
K003241 ECAT PET SCANNER Cti Pet Systems, Inc. KPS Class II 2000-12-13
K001550 EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR Imatron, Inc. LLZ Class II 2000-12-11
K002782 HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION Nuclear Diagnostics AB LLZ Class II 2000-12-05
K003141 UBM PLUS, MODEL P45 Paradigm Medical Industries, Inc. IYO Class II 2000-12-05
K002894 MEDIPRIME Algotec Systems, Ltd. LLZ Class II 2000-12-05
K002807 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING Acuson Corp. IYO Class II 2000-12-01
K003266 SIREMOBIL ISO-C 3D Siemens Medical Solutions USA, Inc. OXO Class II 2000-12-01
K001510 OS-2000 OPTICAL SONOGRAPHY SYSTEM Advanced Diagnostics, Inc. NCS Class II 2000-11-30
K002472 DELTA 32 AND DELTA 32 TACT Instrumentarium Imaging, Inc. IZH Class II 2000-11-29
K002916 SURGI-VISION PROSTATE COIL Surgi-Vision, Inc. MOS Class II 2000-11-28
K003473 DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM Elscintec Systems , Ltd. IZH Class II 2000-11-28
K001947 T.I.M.S., VERSION 2.00 Total Medical Information Management Systems, Inc. LLZ Class II 2000-11-22
K003525 VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYN Class II 2000-11-22
K002860 MODEL 6900GE-64: C-SPINE ARRAY Midwest Rf, LLC MOS Class II 2000-11-22
K002864 MODEL 6600GE-64: TRAMA NECK ARRAY Midwest Rf, LLC MOS Class II 2000-11-21
K002724 NUMALINK Numa, Inc. LLZ Class II 2000-11-17
K003408 CT CORD IQ OPTION 1.0 GE Medical Systems JAK Class II 2000-11-17
K002597 CN ACQUISITION STATION Cardionow, Inc. LLZ Class II 2000-11-17
K002840 MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM The Phantom Laboratory, Inc. IZI Class II 2000-11-17
K002780 VIATRONIX VISUALIZATION SYSTEM (VVS) Viatronix, Inc. LLZ Class II 2000-11-17
K001544 VAGINAL APPLICATOR SHIELDED Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2000-11-17
K003399 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 2000-11-16
K002774 HRH-63 HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2000-11-16
K003434 ALLEGRO TB, ALLEGRO N Adac Laboratories KPS Class II 2000-11-16
K002584 ECAT ACCEL PET SCANNER Cti Pet Systems, Inc. KPS Class II 2000-11-16
K002608 INVAC Duncan Hynd Associates, Ltd. IYE Class II 2000-11-16
K001841 35/CD CINECONVERTER Tagarno A/S LMA Class II 2000-11-15
K002357 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS Pie Medical IYO Class II 2000-11-09
K003340 OBC-149 BREAST ARRAY COIL Mri Devices Corp. MOS Class II 2000-11-08
K003256 PCCR DIGITAL IMAGING DEVICE Orex Computed Radiography, Ltd. MQB Class II 2000-11-08
K002640 FREEDOM AUTOMATIC FILM PROCESSOR J. Morita USA, Inc. IXW Class II 2000-11-08
K003331 QWH-149 WRIST ARRAY COIL Mri Devices Corp. MOS Class II 2000-11-08
K002509 NOVALIS (SHAPED BEAM SURGERY SYSTEM) Brainlab AG MUJ Class II 2000-11-03
K002715 ECAT PET SCANNER Cti Pet Systems, Inc. KPS Class II 2000-10-31
K002590 CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER Cedara Software Corp. LLZ Class II 2000-10-31

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