meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
39
Latest Decision
1992-12-30

Clearances · page 120 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K924756 MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL Siemens Medical Solutions USA, Inc. LNH Class II 1992-12-30
K926082 CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT Biodan Medical Systems, Ltd. IZI Class II 1992-12-30
K924719 ANCOR Siemens Medical Solutions USA, Inc. IZI Class II 1992-12-30
K920879 BRAINSCAN RADIOSURGERY MODULE Brainlab IYE Class II 1992-12-29
K925844 PHILIPS SUPER CP FAMILY Philips Medical Systems, Inc. IZO Class I 1992-12-28
K923455 HFG 350, 650, 1050 Varian Canada, Inc. KPR Class II 1992-12-28
K925105 PHILIPS MEDIO CP FAMILY Philips Medical Systems, Inc. IZO Class I 1992-12-28
K925705 ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM Denar Corp. IWY Class I 1992-12-28
K925251 LIXI IMAGING SCOPE. MODIFICATION Lixi, Inc. JAA Class II 1992-12-28
K924137 CSP-A (CEILING SUSPENDED POSITIONER-ANGIO) Fischer Imaging Corp. IZI Class II 1992-12-28
K923140 MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL Hitachi Medical Systems America, Inc. LNH Class II 1992-12-24
K924653 MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL Mri Devices Corp. LNH Class II 1992-12-24
K923423 QUADATURE HEAD/NECK/VASCULAR COIL Medical Advances, Inc. LNH Class II 1992-12-24
K924479 MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES Siemens Medical Solutions USA, Inc. LNH Class II 1992-12-24
K921653 VECTRA MAGNETIC RESONANCE SYSTEM General Electric Co. LNH Class II 1992-12-24
K924426 MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG Siemens Medical Solutions USA, Inc. LNH Class II 1992-12-18
K914821 CRS RADIATION BEAM SCANNER Consolidated Radiation Services, Inc. IYI Class II 1992-12-17
K924459 DIGISCAN 2 Siemens Medical Solutions USA, Inc. IXK Class II 1992-12-17
K923990 FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE Fujifilm Medical System U.S.A., Inc. IXK Class II 1992-12-17
K922564 6 FRENCH CATHETER S. and H. Engineering, Inc. JAQ Class II 1992-12-17
K924828 BI-N Xre Corp. IZI Class II 1992-12-17
K925716 BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC Bennett X-Ray Corp. IYB Class I 1992-12-17
K923786 POLYDOROS XS50 AND SX80 Siemens Medical Solutions USA, Inc. IZO Class I 1992-12-17
K925302 PHILIPS INTEGRIS H/HM SYSTEM Philips Medical Systems, Inc. IZF Class II 1992-12-17
K925997 KODAK EKTASCAN SP CASSETTE Eastman Kodak Company IXJ Class I 1992-12-17
K922303 M-LINK Medimage, Inc. KPS Class II 1992-12-11
K924126 EUB-405 Hitachi Medical Systems America, Inc. IYO Class II 1992-12-10
K923348 OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED Zeiss Humphrey System ITX Class II 1992-12-10
K924759 COLLIMATOR LIGHT SOURCE Denar Corp. IZT Class II 1992-12-09
K924311 SONOMED 4000P ULTRASONIC PACHYMETER Sonomed, Inc. IYO Class II 1992-12-08
K924552 DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II) E.I. Dupont DE Nemours & Co., Inc. IXW Class II 1992-12-07
K925170 SHIMADZU X-RAY TUBE STAND BH-100 SERIES Shimadzu Medical Systems IYB Class I 1992-12-07
K924877 OPTITRACK Adac Laboratories KPS Class II 1992-12-07
K924478 MTV-250A, MTV-300A Toshiba America Medical Systems, In.C LMA Class II 1992-12-04
K924586 CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE Capintec Instruments, Inc. IZD Class I 1992-12-03
K925169 SHIMADZU RADIOGRAPJHIC STAND BR-100 Shimadzu Medical Systems KPX Class II 1992-12-03
K924498 MAXXUS GE Medical Systems KPS Class II 1992-12-03
K923269 CONVEX AND LINEAR ARRAY TRANSDUCERS Aloka Co., Ltd. IYO Class II 1992-12-03
K914862 CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS Medasonics, Inc. IYN Class II 1992-12-03
K922222 ANGIOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. IZI Class II 1992-12-02
K923536 NUCLEAR MEDICINE LASER IMAGER General Scanning, Inc. LMC Class II 1992-11-30
K923025 SIGNA BREAST COIL AND ARRAY ACCESSORY GE Medical Systems LNH Class II 1992-11-27
K924430 AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 Alphatek Corp. IXW Class II 1992-11-27
K922591 UROLOGICAL C-ARM TABLE, MODEL #056-450 Biodan Medical Systems, Ltd. IXR Class II 1992-11-27
K924349 GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP General Electric Co. LNH Class II 1992-11-27
K925174 SHIMADZU RADIOGRAPHIC TABLE BK-100 Shimadzu Medical Systems IZZ Class II 1992-11-27
K924229 VG-A MIG Vortech Data, Inc. LMD Class I 1992-11-27
K923107 BODY BAND RESTRAINT STRAP SET Cook, Inc. JAA Class II 1992-11-27
K925175 SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90 Shimadzu Medical Systems IXR Class II 1992-11-27
K925332 BENNETT X-RAY ID PLUS Bennett X-Ray Technologies JAC Class I 1992-11-27
K922470 IES, IMAGE ENHANCEMENT SYSTEM Open Mri, Inc. LNH Class II 1992-11-27
K922286 MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER Norland Corp. KGI Class II 1992-11-27
K901615 PULMOCATH INTRABRONCHIAL CATHETER Omnitron Intl., Inc. JAQ Class II 1992-11-27
K921991 PLATO RADIATION THERAPY PLANNING SYSTEM Nucletron-Oldelft Corp. IYE Class II 1992-11-27
K923552 KODAK X-OMAT FS-1A PROCESSOR Eastman Kodak Company IXW Class II 1992-11-27
K922977 EXPOSET S & S Inficon, Inc. JAA Class II 1992-11-27
K924345 RADIOGRAPHIC FILM MARKETING SYSTEM Fischer Imaging Corp. JAC Class I 1992-11-27
K921341 ACUSON V714OR TRANSDUCER Acuson Corp. ITX Class II 1992-11-27
K923471 PLANMED CYTOGUIDE Planmed OY IZH Class II 1992-11-24
K913425 DIAL-A-RAD PORTA RAD TABLE Dial-A-Rad IXQ Class II 1992-11-24
K915696 INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE Interspec, Inc. ITX Class II 1992-11-24
K924593 DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 Philips Medical Systems, Inc. IXL Class II 1992-11-24
K924164 DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT Eigen JAA Class II 1992-11-23
K921962 LORAD DIGITAL SPOT MAMMOGRAPHY Lorad Medical Systems, Inc. IZH Class II 1992-11-23
K924154 KINEMATIC MRI MOVIEMAKER Resonex, Inc. LNH Class II 1992-11-23
K923654 POLY DIAGNOST CDX Xre Corp. IZI Class II 1992-11-20
K921705 ULTRASONIC PACHYMETER Precision Corneal Instruments IYO Class II 1992-11-16
K923619 ACCULITE SSL Medical Alignment Systems IWE Class I 1992-11-16
K921940 MRT-35(TM) Toshiba America Mri, Inc. LNH Class II 1992-11-10
K915647 DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 Pie Medical Equipment B.V. ITX Class II 1992-11-09
K923042 DU PONT LINX HD-25 LASR IMAGER E.I. Dupont DE Nemours & Co., Inc. LLZ Class II 1992-11-09
K921941 SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT General Electric Co. LNH Class II 1992-11-09
K913890 SONICATH(TM) 3.5 F, 20 MHZ Boston Scientific Corp ITX Class II 1992-11-09
K920578 PHILIPS GYROSCAN T5 SERIES II Philips Medical Systems North America, Inc. LNH Class II 1992-11-06
K920791 GYROSCAN S15/ACS-II Philips Medical Systems, Inc. LNH Class II 1992-11-06
K923948 SAT PAD Alliance Pharmaceutical Corp. LNH Class II 1992-11-06
K913435 PXI URCD Brotherston/Pxi KPR Class II 1992-11-05
K923881 QUADRATURE CERVICAL CONTOUR COIL Magnetic Research, Inc. LNH Class II 1992-11-05
K913436 PXI PNEUMATIC COMPRESSION PADDLE Brotherston/Pxi IZG Class II 1992-11-05
K921381 MEDGRAPHIX INTL VR 1000 SERIES Medgraphix Intl. LMC Class II 1992-11-02
K921108 CMS RECORD AND VERIFY Computerized Medical Systems, Inc. KPQ Class II 1992-11-02
K921906 HARRIS MODEL 2000 Harris Mfg. Co. LMC Class II 1992-11-02
K920906 DGH-500 PACHYMETER Dgh Technology, Inc. IYO Class II 1992-11-02
K923823 3D IMAGING Resonex, Inc. LNH Class II 1992-10-30
K923851 ACQSIM SIMULATOR/LOCALIZER Philips Medical Systems (Cleveland), Inc. KPQ Class II 1992-10-27
K922443 VERT-X UNIVERSAL VERTICAL BUCKY STAND Afp Imaging Corp. IXY Class I 1992-10-26
K923913 NOISE REDUCTION UNIT W/ LAST IMAGE HOLD Jms Imaging Products, Inc. LLZ Class II 1992-10-22
K923897 A BREAST COIL FOR THE GYREX 2T-DIX Elscint, Inc. LNH Class II 1992-10-21
K923585 DIGITAL FLUORO STORE Eigen JAA Class II 1992-10-21
K922605 TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 Biodan Medical Systems, Ltd. IYO Class II 1992-10-20
K923775 R-MADE HEAD/ARM SUPPORT R-Made, Inc. IXQ Class II 1992-10-20
K923680 ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM Minnetonka Medical LMB Class I 1992-10-20
K920319 SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI Siemens Gammasonics, Inc. LLZ Class II 1992-10-20
K921192 CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM GE Medical Systems JAK Class II 1992-10-20
K922604 DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE Biodan Medical Systems, Ltd. IYO Class II 1992-10-20
K923813 PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION Philips Medical Systems, Inc. IZI Class II 1992-10-16
K922287 E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS I.Z.I. Corp. KPQ Class II 1992-10-16
K921986 PATIENT INFORMATION MANAGER (PIM) Continental X-Ray Corp. IZH Class II 1992-10-16
K924798 BATTERY PACK Portable Power Systems, Inc. IZL Class II 1992-10-16
K924012 FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE Fujifilm Medical System U.S.A., Inc. IXK Class II 1992-10-16

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