meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
20
Latest Decision
2000-10-31

Clearances · page 95 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K002611 SIGNA MFO/I MAGNETIC RESONANCE SYSTEM GE Medical Systems LNH Class II 2000-10-31
K002424 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A Toshiba America Medical Systems, In.C LLZ Class II 2000-10-27
K002880 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC Pie Medical IYN Class II 2000-10-26
K002531 EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 Toshiba America Mri, Inc. LNH Class II 2000-10-26
K002483 POWER 5000 GENERAL PURPOSE COIL Usa Instruments, Inc. MOS Class II 2000-10-25
K001295 PIPER Rtek Medical Systems, LLC MUJ Class II 2000-10-25
K002522 OPART, MODEL MRT-600 Toshiba America Mri, Inc. MOS Class II 2000-10-25
K001070 RADIOMED SOURCE Radiomed Corp. KXK Class II 2000-10-24
K003152 SOMATOM SMILE Siemens Medical Solutions USA, Inc. JAK Class II 2000-10-24
K001163 DMLC IV-ERGO 3D Line USA, Inc. IXI Class II 2000-10-23
K002500 X-POSURE SYSTEM VERSION 2 RAD Pronosco A/S KGI Class II 2000-10-23
K002446 RE-ENTRANT CHAMBER, MODEL 1008 OR 44D Sun Nuclear Corp. KXK Class II 2000-10-23
K003121 MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS Medison America, Inc. IYO Class II 2000-10-20
K003125 SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2000-10-20
K000246 RADIOCAMERAS EXTRACRANIAL SYSTEM Surgical Navigation Technologies, Inc. IYE Class II 2000-10-20
K002229 WACKERS-LIU CQ SOFTWARE Eclipse Systems, Inc. KPS Class II 2000-10-20
K002519 VITREA 2, VERSION 2.1 Vital Images, Inc. LLZ Class II 2000-10-19
K002444 PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 Sun Nuclear Corp. IYE Class II 2000-10-18
K002482 VISION 9000 PHASED ARRAY TORSO COIL Usa Instruments, Inc. MOS Class II 2000-10-17
K002936 MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM Sectra-Imtec AB LLZ Class II 2000-10-17
K002198 FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS Fluoro Scan Imaging Systems, Inc. OWB Class II 2000-10-17
K002420 HITACHI ALTAIRE Hitachi Medical Systems America, Inc. LNH Class II 2000-10-17
K002147 FOCUS Computerized Medical Systems, Inc. MUJ Class II 2000-10-13
K003014 SOMATOM EMOTION MS Siemens Medical Solutions USA, Inc. JAK Class II 2000-10-12
K002345 SURGI-VISION URETHRAL COIL Surgi-Vision, Inc. MOS Class II 2000-10-11
K002179 MAGNETOM ALLEGRA SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2000-10-11
K002978 LIGTHSPEED 3.0 CT SCANNER SYSTEM GE Medical Systems JAK Class II 2000-10-10
K002490 INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. LNH Class II 2000-10-03
K002833 MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER Standard Imaging, Inc. KPT Class II 2000-09-28
K002144 MEDLINK DIAGNOSTIC OFFLINE WORKSTATION Advanced Technology Laboratories, Inc. LLZ Class II 2000-09-28
K001833 PREFERENCE TREATMENT SYSTEM Northwest Medical Physics Equipment, Inc. IYE Class II 2000-09-28
K002711 HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER Hologic, Inc. KGI Class II 2000-09-28
K002039 ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART Cti Pet Systems, Inc. LLZ Class II 2000-09-27
K002146 KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY Eastman Kodak Company LMC Class II 2000-09-27
K002005 BOLUSPRO ULTRA Marconi Medical Systems, Inc. JAK Class II 2000-09-22
K002784 ALOKA UST-5280-5 Aloka Co., Ltd. ITX Class II 2000-09-20
K002242 POLESTAR N-10 Odin Technologies , Ltd. LNH Class II 2000-09-20
K001366 PROSTEC 125I BRANCHYTHERAPY SNAPSEED Prostec, LLC KXK Class II 2000-09-19
K002553 DS DS I-SERIES Smv America KPS Class II 2000-09-15
K002685 CORDLESS COMPACT MOBILE X-RAY SYSTEM Medison Radiology Systems, Inc. IZL Class II 2000-09-15
K002470 M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER Agilent Technologies, Inc. IYN Class II 2000-09-08
K001765 LOOK COLLAGEN SPACERS, MODEL 1514B Surgical Specialties Corp KXK Class II 2000-09-07
K002016 PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc. OWB Class II 2000-09-06
K001796 GYROSCAN INTERA (R7.5) Philips Medical Systems North America, Inc. LNH Class II 2000-09-06
K001987 EXPLORER GRADIENT Philips Medical Systems North America, Inc. LNH Class II 2000-09-06
K994103 OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT Olympus America, Inc. ITX Class II 2000-09-05
K993675 PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM Nomos Corp. MUJ Class II 2000-09-05
K002051 INVIDOS Scanditronix Medical AB IYE Class II 2000-09-05
K002602 OBC-63 MEBREAST ARRAY COIL Mri Devices Corp. MOS Class II 2000-09-05
K002312 PROTON VISION 7.0 Varian Medical Systems, Inc. MUJ Class II 2000-08-30
K001946 NEUROVASCULAR ARRAY COIL Ge Medical Systems, Inc. MOS Class II 2000-08-30
K001052 MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX Med-Tec,Inc. IYE Class II 2000-08-30
K002539 OBC-096 BREAST ARRAY COIL Mri Devices Corp. MOS Class II 2000-08-30
K002533 TCD 100M, PWD13 TRANSDUCER Spencer Technologies IYN Class II 2000-08-30
K002404 MICRO-MAX, MODEL 319 Tek Marketing, Inc. IXW Class II 2000-08-30
K994283 MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM Medis Medical Imaging Systems BV LNH Class II 2000-08-30
K002100 XIMX SYSTEM Medical Manager Research Development LLZ Class II 2000-08-25
K001681 POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM Smv America KPS Class II 2000-08-25
K002491 COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS Medison Co., Ltd. IYN Class II 2000-08-25
K002240 RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 Precision Therapy Intl., Inc. MUJ Class II 2000-08-23
K000475 BRACHYSEED Draximage, Inc. KXK Class II 2000-08-22
K002194 TREATVISION Varian Medical Systems, Inc. LHN Class II 2000-08-18
K000209 DOSE 1 Scanditronix Wellhofer North America IYE Class II 2000-08-18
K001773 ORTHONE Oni, Inc. LNH Class II 2000-08-18
K002415 POWERDRIVE 350 OPTION Philips Medical Systems (Cleveland), Inc. LNH Class II 2000-08-18
K002397 M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER Agilent Technologies, Inc. IYN Class II 2000-08-17
K001870 MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL Usa Instruments, Inc. MOS Class II 2000-08-14
K001944 HAC-300 HEAD ARRAY COIL Mri Devices Corp. MOS Class II 2000-08-14
K002239 SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM Kontron Medical Systems Sas IYN Class II 2000-08-08
K002225 OR TABLE/MAGNETOM OPEN VIVA SYSTEM Siemens Medical Solutions USA, Inc. LNH Class II 2000-08-08
K002258 ULTRAGUIDE CT-GUIDE 1010 Ultraguide , Ltd. JAK Class II 2000-08-08
K001825 STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER Standard Imaging, Inc. JAQ Class II 2000-08-02
K002085 ULTRASOUND SCANNER, TYPE 1101 B & K Medical A/S IYO Class II 2000-08-01
K990517 EXPLORER CVS TRANSCRANIAL DOPPLER Diagnostic Medical Systems IYN Class II 2000-08-01
K002185 SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM Medison America, Inc. IYN Class II 2000-08-01
K001400 ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2000-08-01
K001748 MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 2000-07-27
K001753 MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 2000-07-27
K001750 MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 2000-07-21
K992414 PROTON BEAM THERAPY SYSTEM (PBTS) Optivus Technology, Inc. LHN Class II 2000-07-21
K001754 MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 2000-07-19
K001751 MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 2000-07-19
K001752 MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 2000-07-19
K001276 MEDICAL IMAGE MERGE (MIM) Syntermed, Inc. KPS Class II 2000-07-17
K994018 PHARMASEED, MODEL BT-125-3 Syncor Pharmaceuticals, Inc. KXK Class II 2000-07-17
K001582 LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE Usa Instruments, Inc. MOS Class II 2000-07-17
K994016 PHARMASEED, MODEL BT-103-3 Syncor Pharmaceuticals, Inc. KXK Class II 2000-07-14
K993674 POCKET ULTRASONIC PACHYMETER Quantel Medical IYO Class II 2000-07-13
K002003 HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING Atl Ultrasound, Inc. IYN Class II 2000-07-13
K001747 MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco NV Display Systems LLZ Class II 2000-07-13
K994413 BRAINSCAN Brainlab AG MUJ Class II 2000-07-13
K001812 PEDIATRIC REFERENCE DATA Lunar Corp. KGI Class II 2000-07-10
K001596 LIFERX Bowdengs Technologies, LLC LLZ Class II 2000-07-06
K001334 HITACHI AIRIS II Hitachi Medical Systems America, Inc. LNH Class II 2000-07-06
K001894 MODIFICATION TO E-SCAN Biosound Esaote, Inc. LNH Class II 2000-07-06
K001756 LUNAR REPORT GENERATOR II Lunar Corp. KGI Class II 2000-07-06
K001888 UNICORN MODEL SYS0630 Danish Diagnostic Development A/S KPS Class II 2000-06-30
K001682 VSCORE WITH EKG SIGNAL GATING Vital Images, Inc. JAK Class II 2000-06-30
K993939 NICOLET EME LEGEND TC22 Nicolet Biomedical IYN Class II 2000-06-29
K001700 XPLAN 2.1 Radionics, Inc. MUJ Class II 2000-06-28

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