meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
26
Latest Decision
1988-12-13

Clearances · page 133 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883976 CFX 625 Fischer Imaging Corp. IZO Class I 1988-12-13
K875187 SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT Shimadzu Corp. IYO Class II 1988-12-12
K884743 TEMPOROMANDIBULAR JOINT COIL (TMJ) Diasonics, Inc. LNH Class II 1988-12-05
K884606 MT/S (SPINE TRANSMIT COIL) Diasonics, Inc. LNH Class II 1988-12-05
K883752 ACUSON L538 TRANSDUCER Acuson Corp. IYO Class II 1988-12-01
K883547 GE MR MAX SYSTEM General Electric Co. LNH Class II 1988-11-30
K884008 SONY CINE VIDEO SYSTEM SME-3300 Sony Medical Electronics Co. IZI Class II 1988-11-30
K884604 MT/S CARLSON SPINE COIL, PART # 100-50082500-01 Diasonics, Inc. LNH Class II 1988-11-30
K884603 SHOULDER TRANSMIT AND RECEIVE COILS Diasonics, Inc. LNH Class II 1988-11-30
K881140 ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY Advanced Technology Laboratories, Inc. IYO Class II 1988-11-29
K882755 MODEL 500V VASCULAR SPECTRUM ANALYZER Multigon Industries, Inc. IYN Class II 1988-11-29
K884369 POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM General Electric Co. LNH Class II 1988-11-28
K883372 ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT Ausonics Pty , Ltd. JAA Class II 1988-11-25
K882453 POLYSCAN DIGITAL SCANNER Medical and Scientific Enterprises, Inc. IYW Class I 1988-11-23
K883476 VOXEL FLINGER(TM) 3-D IMAGING SYSTEM Reality Imaging Corp. LLZ Class II 1988-11-23
K884062 MAGNETOM (M, H, 42, 63) SEQUENCES Siemens Medical Solutions USA, Inc. LNH Class II 1988-11-23
K884148 DISKCAM DC 6001 Camtronics, Ltd. LMB Class I 1988-11-23
K883985 CARDIAC CX Fischer Imaging Corp. JAA Class II 1988-11-21
K883994 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1988-11-21
K883860 ADVANTAGE Fischer Imaging Corp. IZI Class II 1988-11-21
K883872 CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL Siemens Medical Solutions USA, Inc. LNH Class II 1988-11-21
K883831 IMAGER Fischer Imaging Corp. IZI Class II 1988-11-21
K880404 CSI/QCT Columbia Scientific, Inc. KGI Class II 1988-11-17
K875378 SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION Shimadzu Precision Instruments, Inc. KPS Class II 1988-11-16
K883604 MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS) Medrad, Inc. LLZ Class II 1988-11-15
K883756 TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM Toshiba Medical Systems LNH Class II 1988-11-14
K883019 SATURNE 42 AND 43 General Electric Co. IYE Class II 1988-11-10
K883621 INSTRUMENTARIUM ULF MR IMAGING SYSTEM Instrumentarium Corp. LNH Class II 1988-11-10
K882875 STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY Lorad Medical Systems, Inc. IZH Class II 1988-11-07
K883664 LUM VASCULAR PROCEDURE SYSTEM #B5200A General Electric Co. IYB Class I 1988-11-07
K882939 NIOBI-X RADIATION REDUCTION FILTER American Canadian Products, Inc. ITY Class I 1988-11-04
K883481 HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE Hewlett-Packard Co. IYO Class II 1988-11-04
K883834 MEDRAD OMNIPLANE 300 SYSTEM Medrad, Inc. KPR Class II 1988-11-04
K882271 CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY Nuccardiac Software, Inc. LLZ Class II 1988-11-03
K880690 SIEMENS PACS/I-A Siemens Gammasonics, Inc. IZI Class II 1988-10-31
K883699 B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER Fonar Corp. LNH Class II 1988-10-31
K883863 GENESIS 180 Fischer Imaging Corp. IXR Class II 1988-10-21
K883161 HIMOBILIX 2N Bay X-Ray, Inc. JAA Class II 1988-10-21
K882754 REPORT AND IMAGE MANAGEMENT SYSTEM Medical Image Processing Specialists, Inc. LMD Class I 1988-10-21
K884134 MICRO-X 100CP Fischer Imaging Corp. IZO Class I 1988-10-21
K883974 TANGENT II Fischer Imaging Corp. IZZ Class II 1988-10-20
K881305 TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM Toshiba Medical Systems JAK Class II 1988-10-19
K883649 INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H Instrumentarium Corp. LNH Class II 1988-10-19
K883519 FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000) Philips Medical Systems (Cleveland), Inc. LNH Class II 1988-10-19
K883864 RADKOR SFR-70 Radkor, Inc. IYB Class I 1988-10-19
K882358 PULSED FLUOROSCOPIC CONTROL MODEL:PF-02 U.S. Imaging, Inc. IZI Class II 1988-10-19
K883648 BETA 3000M MOBILE NMR IMAGING SYSTEM Fonar Corp. LNH Class II 1988-10-19
K883482 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1988-10-19
K883885 RADKOR, RF-159 Radkor, Inc. KXJ Class II 1988-10-19
K883737 VFQ HEAD COIL Resonex, Inc. LNH Class II 1988-10-13
K883092 BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR Bennett X-Ray Corp. IZL Class II 1988-10-13
K882478 100-01778-52 ULTRASOUND SYSTEM Diasonics, Inc. IYO Class II 1988-10-12
K881481 DIGITRON STENOSIS PROTOCOL Siemens Gammasonics, Inc. LLZ Class II 1988-10-12
K883264 SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25 Philips Medical Systems, Inc. IYE Class II 1988-10-11
K882378 P-7 COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems (Cleveland), Inc. JAK Class II 1988-10-11
K883101 DVS (OPTION 01) O.M.I. Oncology Microsystems, Inc. IYE Class II 1988-10-07
K883546 TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER Advanced Technology Laboratories, Inc. IYO Class II 1988-10-07
K883516 DIASONICS MT/P IMAGING SYSTEM Diasonics, Inc. LNH Class II 1988-10-07
K883520 0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST Philips Medical Systems (Cleveland), Inc. LNH Class II 1988-10-07
K883965 PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR Teknar, Inc. IYO Class II 1988-10-05
K883067 MODIFIED SL-SERIES LINEAR ACCELERATORS Philips Medical Systems, Inc. IYE Class II 1988-09-30
K883280 HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED Hologic, Inc. KGI Class II 1988-09-29
K883360 HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM Hologic, Inc. KGI Class II 1988-09-27
K882231 SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION) Philips Medical Systems, Inc. IYE Class II 1988-09-22
K883378 VISTA MR 2055 HP SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1988-09-22
K882018 MEDACORD PVL, PERSONAL VASCULAR LABORATORY Medasonics, Inc. JAF Class II 1988-09-21
K882133 MAMMO M Ziehm International, Inc. IZH Class II 1988-09-19
K882326 VARIAN CLINAC 1800S Varian Assoc., Inc. IYE Class II 1988-09-19
K883702 EXCELVIEW ILLUMINATOR Excel Medical Products, Inc. IXC Class I 1988-09-19
K881993 PXI (PERSONAL X-RAY IMAGER) 512 Oklahoma Digital Technologies, Inc. LLZ Class II 1988-09-19
K882729 MEVATRON, M 2 CLASS Siemens Medical Laboratories, Inc. IYE Class II 1988-09-19
K883650 INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110 Instrumentarium Corp. LNH Class II 1988-09-16
K881889 CANON IOL ESTIMATOR KU-1 Canon USA, Inc. IYO Class II 1988-09-15
K882311 SHIMADZU LATERAL C-ARM MH-31 Shimadzu Precision Instruments, Inc. JAA Class II 1988-09-14
K883072 DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM Siemens Gammasonics, Inc. IZI Class II 1988-09-14
K881697 BREAST LESION LOCALIZATION NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic IZH Class II 1988-09-14
K883622 INSTRUMENTARIUM ULF MR IMAGING SYSTEM Instrumentarium Corp. LNH Class II 1988-09-14
K883431 RAYMAX 2100 MODELS 2130 & 2136 Raymax Medical Corp. IZO Class I 1988-09-12
K881701 RADKOR SFC-21 Radkor, Inc. IYB Class I 1988-09-08
K883160 CATAPULT BUCKY (KATAPULT BLENDA) Bay X-Ray, Inc. KPR Class II 1988-09-08
K882015 TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM Ultramed, Inc. IYN Class II 1988-09-08
K882737 ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER Acuson Corp. IYN Class II 1988-09-08
K883153 UNDISTAT WITH EXPLORATOR 35 (UCS 35E) Bay X-Ray, Inc. IXR Class II 1988-09-06
K883154 SELDIX 325 TWO PULSE GENERATOR/CONTROL Bay X-Ray, Inc. IZO Class I 1988-09-06
K883162 TELESTATIX X-RAY TABLE Bay X-Ray, Inc. IXR Class II 1988-09-06
K883155 RASTIX X-RAY TABLE Bay X-Ray, Inc. KXJ Class II 1988-09-06
K883521 C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS Philips Medical Systems (Cleveland), Inc. LNH Class II 1988-09-02
K881696 RADKOR XG-325 Radkor, Inc. IZO Class I 1988-09-02
K883527 GRID/RADIOGRAPHIC Umi, Inc. IXJ Class I 1988-09-02
K881700 RADKOR KOB-84 Radkor, Inc. KXJ Class II 1988-09-02
K881674 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC Shimadzu Precision Instruments, Inc. JAK Class II 1988-09-02
K883081 RADKOR, XG-515 Radkor, Inc. IZO Class I 1988-09-02
K880878 CX250 MOBILE GAMMA CAMERA & DCS CONSOLE Philips Medical Systems (Cleveland), Inc. IYX Class I 1988-09-01
K881013 MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A Toshiba Medical Systems IYX Class I 1988-08-29
K881850 TEKNAR PERCU-SCAN Teknar, Inc. IYO Class II 1988-08-29
K874854 GPS/WGPS/PREVIEW GP Labsonics, Inc. IYO Class II 1988-08-25
K881834 MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Ge Medical Systems Information Technologies IYO Class II 1988-08-24
K883238 GENESIS II TRANSCRANIAL PROBE Biosound, Inc. IYO Class II 1988-08-24
K873121 GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS) General Electric Co. LMD Class I 1988-08-23
K882906 DENTASCAN Mpdi, Inc. JAK Class II 1988-08-19

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