Review Panel
Radiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 14,721
- Product Codes (page)
- 25
- Latest Decision
- 2001-07-11
Clearances · page 93 of 148
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K011173 | TELEPAX | Imed Systems & Consulting, LLC | LLZ | Class II | 2001-07-11 |
| K011311 | UROLOGIC | Pck Electronic Industry and Trade Co, Ltd. | OWB | Class II | 2001-07-10 |
| K011205 | ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 | Isoaid | KXK | Class II | 2001-07-10 |
| K011141 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC | Shimadzu Corp. | JAK | Class II | 2001-07-03 |
| K003438 | SMART RAD | Cmt Medical Technologies, Ltd. | MQB | Class II | 2001-07-03 |
| K011180 | CT/MASTER, VERSION 1.0 | Columbia Scientific, Inc. | JAK | Class II | 2001-06-27 |
| K010950 | CYPRESS SYSTEM | Acuson Corp. | IYO | Class II | 2001-06-27 |
| K010938 | SYNGO MULTIMODALITY WORKSTATION | Siemens Medical Solutions USA, Inc. | LLZ | Class II | 2001-06-26 |
| K011119 | BRACHYSEED PD-103 MODELS #PD1 | Draximage, Inc. | KXK | Class II | 2001-06-25 |
| K010916 | PTW DOSIMETRY DIODE, T60008 | Ptw-New York Corp. | IYE | Class II | 2001-06-20 |
| K011284 | THIN FILM DRESSING FOR ULTRASOUND EXAM | Martin E. Wendelken | ITX | Class II | 2001-06-20 |
| K011486 | Q-RAD RADIOGRAPHIC SYSTEM | Quantum Medical Imaging, LLC | KPR | Class II | 2001-06-20 |
| K011292 | ZIEHM VISION | Ziehm International, Inc. | OWB | Class II | 2001-06-20 |
| K011572 | QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) | Digirad Corp. | KPS | Class II | 2001-06-15 |
| K010817 | MX8000 V5.0 CT SYSTEM | Philips Medical Systems (Cleveland), Inc. | JAK | Class II | 2001-06-15 |
| K011095 | MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM | Iodp SA | IYO | Class II | 2001-06-13 |
| K011617 | LIFEJET PRINTER 400 | Ferrania S.P.A. Stabilimento DI Ferrania | LMC | Class II | 2001-06-08 |
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM | GE Medical Systems | JAA | Class II | 2001-06-08 |
| K011611 | CARDIOCAM MODEL 9CSY0799 | Danish Diagnostic Development A/S | KPS | Class II | 2001-06-08 |
| K011417 | ULTRASOUND SCANNER, TYPE 2102 | B-K Medical A/S | IYO | Class II | 2001-06-08 |
| K003778 | BREAST-BOARD (MULTIPLE) | Arplay Medical S.A. | IYE | Class II | 2001-06-08 |
| K010802 | CARDIAC VIEW, MODEL 2001 | Magna Lab, Inc. | MOS | Class II | 2001-06-08 |
| K002911 | XSCAN32 TELERADIOLOGY SOFTWARE | Radiographic Digital Imaging, Inc. | LLZ | Class II | 2001-06-07 |
| K011485 | PINNACLE MAGNETIC RESONANCE IMAGING SCANNER | Fonar Corp. | LNH | Class II | 2001-06-06 |
| K011466 | QED DIODE DETECTORS, MODELS 1112-1116 | Sun Nuclear Corp. | LNH | Class II | 2001-06-06 |
| K010682 | HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM | Mds Nordion | MUJ | Class II | 2001-06-05 |
| K011252 | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM | Hitachi Medical Corp. | IYO | Class II | 2001-05-30 |
| K010946 | MARK 9000 PHASED ARRAY SHOULDER COIL | Usa Instruments, Inc. | MOS | Class II | 2001-05-30 |
| K010773 | BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS | Siemens Medical Solutions USA, Inc. | LNH | Class II | 2001-05-30 |
| K011290 | PROGNOST ES, MODEL 0302 0000 | Xmar Corp. | IZF | Class II | 2001-05-30 |
| K011111 | MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) | Modular X-Ray Devices | KPR | Class II | 2001-05-30 |
| K010763 | GOODNET | Goodman Co., Ltd. | LLZ | Class II | 2001-05-25 |
| K003505 | KFA-127 KNEE, FOOT AND ANKLE ARRAY | Mri Devices Corp. | MOS | Class II | 2001-05-25 |
| K011418 | ULTRAGUIDE MR-GUIDE 3000 | Ultraguide , Ltd. | LNH | Class II | 2001-05-24 |
| K011457 | ALOKA SSD-5500 WITH KI AND A-SMA | Aloka Co., Ltd. | IYN | Class II | 2001-05-23 |
| K011246 | DCM 1.0 | Mds Nordion | MUJ | Class II | 2001-05-23 |
| K003890 | VHF ULTRASONIC ARC-SCAN SYSTEM | Ultralink, LLC | IYO | Class II | 2001-05-22 |
| K010513 | CARDIAC VIEW, MODEL 2001 | Magna-Lab, Inc. | MOS | Class II | 2001-05-21 |
| K011188 | GE LOGIQ 9, MODEL 2188900-X | GE Medical Systems | IYN | Class II | 2001-05-18 |
| K010464 | RADCALC, MODEL V.4.0 | Lifeline Software, Inc. | IYE | Class II | 2001-05-17 |
| K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | E-Z-Em, Inc. | JAK | Class II | 2001-05-16 |
| K010730 | MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL | Usa Instruments, Inc. | MOS | Class II | 2001-05-16 |
| K011315 | SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 | Aloka Co., Ltd. | IYN | Class II | 2001-05-15 |
| K011314 | OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM | Aloka Co., Ltd. | ITX | Class II | 2001-05-15 |
| K010472 | PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 | Thomson & Nielsen Electronics, Ltd. | IYE | Class II | 2001-05-08 |
| K010691 | BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION | Philips Medical Systems (Cleveland), Inc. | LNH | Class II | 2001-05-08 |
| K011142 | AQUARIUS WORKSTATION | Terarecon,Inc. | LLZ | Class II | 2001-05-08 |
| K010813 | SIMPLICT | Neorad AS | JAK | Class II | 2001-05-07 |
| K002193 | TETRAD TC-C3-ACP | Tetrad Corp. | ITX | Class II | 2001-05-04 |
| K011224 | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | Advanced Technology Laboratories, Inc. | IYN | Class II | 2001-05-04 |
| K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 | Sun Nuclear Corp. | IYE | Class II | 2001-05-04 |
| K010975 | ECLIPSE 6.5 | Varian Medical Systems, Inc. | IYE | Class II | 2001-05-02 |
| K010275 | DRYSTAR 4500 PRINTER, MODEL 4500 | Agfa Medical Imaging | LMC | Class II | 2001-04-27 |
| K010509 | CEDARS-SINAI BPGS AND MOCO | Smv America | KPS | Class II | 2001-04-27 |
| K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | Theragenics Corp. | KXK | Class II | 2001-04-26 |
| K010726 | MODIFICATION TO MIRAGE | Segami Corp., Inc. | LLZ | Class II | 2001-04-26 |
| K010259 | MEDIFACE PACS | Mediface Co., Ltd. | LLZ | Class II | 2001-04-26 |
| K010417 | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | Nuclear Assoc., Div. Inovision LP | KPT | Class II | 2001-04-26 |
| K003206 | GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 | Proxima Therapeutics, Inc. | KXK | Class II | 2001-04-25 |
| K010225 | DOSIMETRY CHECK | Math Resolutions, LLC | IYE | Class II | 2001-04-24 |
| K010172 | LEAD BLOCKS | Arplay Medical S.A. | IXI | Class II | 2001-04-18 |
| K010174 | TRAY ADAPTERS, MULTIPLE | Arplay Medical S.A. | IYE | Class II | 2001-04-18 |
| K010942 | U04 | Siemens Medical Solutions USA, Inc. | OWB | Class II | 2001-04-12 |
| K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | KXK | Class II | 2001-04-11 |
| K002997 | FIESTA IMAGING OPTION | GE Medical Systems | LNH | Class II | 2001-04-11 |
| K010784 | PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 | Nucletron Corp. | MUJ | Class II | 2001-04-10 |
| K010570 | BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 | Mri Devices Corp. | LNH | Class II | 2001-04-09 |
| K010883 | TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE | Teratech Corp. | ITX | Class II | 2001-04-06 |
| K010129 | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 | Toshiba America Medical Systems, In.C | LNI | Class II | 2001-04-05 |
| K003986 | ULTRASOUND SCANNER TYPE 2102 | B-K Medical A/S | IYN | Class II | 2001-04-03 |
| K010271 | THINKINGNET | Thinking Systems Corp. | LLZ | Class II | 2001-04-03 |
| K010074 | MODEL 455GE PHASED ARRAY WRIST COIL | Medical Advances, Inc. | MOS | Class II | 2001-04-03 |
| K003613 | 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL | GE Medical Systems | MOS | Class II | 2001-04-03 |
| K010792 | MAMMOGRAPH | Digitec Medical Service Corp. | IZH | Class II | 2001-04-03 |
| K010762 | PHILIPS BV LIBRA | Philips Medical Systems, Inc. | OXO | Class II | 2001-04-02 |
| K002856 | AT3C70 TRANSDUCER | Sonora Medical Systems | ITX | Class II | 2001-04-02 |
| K010063 | COUCH FOR TOTAL BODY RADIATION | Arplay Medical S.A. | IYE | Class II | 2001-04-02 |
| K010641 | GE CT-PET SYSTEM | Ge Medical Systems, Inc. | JAK | Class II | 2001-03-30 |
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM | Siemens Medical Corp. | IZI | Class II | 2001-03-30 |
| K010571 | ADC QS/IPD WORKSTATION | Agfa Corp. | LLZ | Class II | 2001-03-28 |
| K010058 | IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK | Witt Biomedical Corporation | LLZ | Class II | 2001-03-21 |
| K002789 | MEDEVIEW SYSTEM | Medeview.Com | LLZ | Class II | 2001-03-21 |
| K010649 | EXHALE DOPPLER SYSTEM | Broncus Technologies, Inc. | IYN | Class II | 2001-03-20 |
| K010631 | NEMIO | Toshiba America Medical Systems, In.C | IYN | Class II | 2001-03-15 |
| K010116 | PLANMED SOPHIE, PLANMED SOPHIE CLASSIC | Planmed OY | IZH | Class II | 2001-03-15 |
| K003899 | IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM | Mri Devices Corp. | LNH | Class II | 2001-03-15 |
| K003947 | FUNCTIONAL BRAIN MAPPING OPTION FOR MRI | GE Medical Systems | LNH | Class II | 2001-03-13 |
| K010062 | STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM | Arplay Medical S.A. | IYE | Class II | 2001-03-13 |
| K003746 | 3D-DOCTOR | Able Software Corp. | LLZ | Class II | 2001-03-13 |
| K010405 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | Biosound Esaote, Inc. | IYN | Class II | 2001-03-13 |
| K004015 | BEAM BLOCK TRAYS | Arplay Medical S.A. | IYE | Class II | 2001-03-13 |
| K010435 | PHILIPS BV PULSERA/ENDURA | Philips Medical Systems, Inc. | OWB | Class II | 2001-03-12 |
| K010391 | ATLAS MULTI-PURPOSE DSA SYSTEM | Cares Built, Inc. | IZI | Class II | 2001-03-12 |
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM | Ge Oec Medical Systems | OXO | Class II | 2001-03-12 |
| K010392 | ATHENA REMOTE CONTROLLED RF SYSTEM | Cares Built, Inc. | JAA | Class II | 2001-03-12 |
| K010393 | APOLLO MOBILE C ARM SYSTEM | Cares Built, Inc. | OXO | Class II | 2001-03-12 |
| K010521 | NICOLET VERSALAB | Nicolet Biomedical | JAF | Class II | 2001-03-09 |
| K003787 | NEWTOM QR-DVT 9000 | Aperio Services, LLC | OAS | Class II | 2001-03-08 |
| K010329 | LOGIQ 500 | General Electric Co. | IYN | Class II | 2001-03-01 |
| K003725 | 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS | Pie Medical | IYO | Class II | 2001-03-01 |
14,721 clearances in the Radiology panel. Data: openFDA.