meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
35
Latest Decision
1993-05-17

Clearances · page 119 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K930763 FIGLEAF SHIELD Byers Industries, Inc. IWT Class I 1993-05-17
K924921 INSTRUMENTARIUM MEGA4 HT Instrumentarium Imaging, Inc. LNH Class II 1993-05-17
K920347 TOP-X 650HF RADIOGRAPHIC X-RAY Control-X, Inc. KPR Class II 1993-05-17
K926554 525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR Tingle X-Ray Products, Inc. KPR Class II 1993-05-17
K924240 PROWESS 2000 Small Systems Group, Inc. IYE Class II 1993-05-17
K921891 SILENT SCAN Avotec, Inc. LNH Class II 1993-05-13
K923481 PHILIPS LASER DISK ARCHIVE Philips Medical Systems, Inc. LMC Class II 1993-05-05
K924472 INSTRUMENTARIUM MEGA4 HT Instrumentarium Imaging, Inc. LNH Class II 1993-05-03
K923581 INSTRUMENTARIUM MEGA4 HT Instrumentarium Imaging, Inc. LNH Class II 1993-05-03
K925050 PC TELERADIOLOGY(TM) Arizona State Radiology LMD Class I 1993-05-03
K930350 RADMAN IMAGE MANAGMENT SYSTEM Infocure Systems, Inc. LMD Class I 1993-04-27
K930230 RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER American Medical Sales, Inc. IXY Class I 1993-04-27
K926064 FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A Scientific Technology , Ltd. JAA Class II 1993-04-27
K926171 MRT-150A, QD SPINE COIL Toshiba America Mri, Inc. LNH Class II 1993-04-27
K924808 MRT-50A SUPER Toshiba America Mri, Inc. LNH Class II 1993-04-27
K923944 PHILIPS GYROVIEW HR - RELEASE 2 Philips Medical Systems North America, Inc. LNH Class II 1993-04-27
K921112 FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK Fujifilm Medical System U.S.A., Inc. KPR Class II 1993-04-27
K930249 BC/WT/PF Tingle X-Ray Products, Inc. IXY Class I 1993-04-27
K920851 MACVIEW Dimensional Medicine, Inc. LLZ Class II 1993-04-20
K923738 HIGH DOSE RATE REMOTE AFTERLOADING CATHETER Cook, Inc. JAQ Class II 1993-04-13
K930220 CASSETTE, RADIOGRAPHIC FILM X-Ray Accessories Mfg. Co. IXA Class II 1993-04-13
K924326 ARTHRODYN 45 DEGREE X-RAY TABLE Arthrodyn, Inc. IXR Class II 1993-04-08
K925289 MATRIX CR 2050, PMI 3000 Heraeus Kulzer, Inc. LMC Class II 1993-04-08
K924630 SURGICAD(TM) VIEW(TM) Surgicad Corp. LLZ Class II 1993-04-07
K930244 JPI X-RAY FILM CASSETTE Jpi, Inc. IXA Class II 1993-04-07
K930997 DOMINATOR RADIOLOGY SYSTEM Dominator Radiology Systems, Inc. LMD Class I 1993-04-07
K923359 PORT-XP Mobile Dental Equipment Corp. IZL Class II 1993-04-07
K924366 PERSONAL DISPLAY SYSTEM Vortech Data, Inc. LLZ Class II 1993-04-07
K921740 COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED Medical Instrumentation & Diagnostics Corp.(Midco) IYE Class II 1993-04-07
K926445 SOYEE ALUMINUM INTERSPACED X-RAY GRID X-Ray Accessories Mfg. Co. IXJ Class I 1993-04-07
K924632 LCM-2-LINAC COUCH-MOUNT SYSTEM Radionics, Inc. IYE Class II 1993-04-07
K926407 MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM Nucletron-Oldelft Corp. KXJ Class II 1993-03-31
K921185 TELEMEDIC TELERADIOLOGY SYSTEM Meditron Corp. LMD Class I 1993-03-29
K920882 ACUSON V714 TRANSDUCER Acuson Corp. ITX Class II 1993-03-26
K926365 MAGMA XHF-30, XHF-40, XHF-50 Imaging and X-Ray Intl., Inc. IZO Class I 1993-03-26
K930090 HELICAT Elscint, Inc. JAK Class II 1993-03-19
K926550 UNIX-LINK General Electric Co. IYX Class I 1993-03-18
K926397 FAST SPIN ECHO MEASURING FUNCTION Hitachi Medical Systems America, Inc. LNH Class II 1993-03-18
K925994 RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS) Rstar, Inc. LMD Class I 1993-03-18
K926261 JPI ALUMINUM INTERSPACED X-RAY GRID Jpi, Inc. IXJ Class I 1993-03-18
K926434 SIS-300(N)-DIA SCAN Micro-Focus Imaging., Inc. JAA Class II 1993-03-18
K923984 SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM Shimadzu Medical Systems LNH Class II 1993-03-16
K925929 RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS) Rstar, Inc. LMD Class I 1993-03-15
K926258 DLX GE Medical Systems IZI Class II 1993-03-15
K924082 PHILIPS TOMOSCAN SR7000 CT SYSTEMS Philips Medical Systems, Inc. JAK Class II 1993-03-10
K923533 ADMARK Planmeca USA, Inc. JAC Class I 1993-03-04
K926404 KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L Eastman Kodak Company JAC Class I 1993-03-04
K925934 WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT Continental X-Ray Corp. IXY Class I 1993-03-04
K923094 MOLYBDENUM Southeastern Medical Diagnostics, Inc. ITY Class I 1993-03-04
K925961 OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM Diagnostic Archives, Inc. IZI Class II 1993-03-02
K925725 CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR Bennett X-Ray Corp. IZH Class II 1993-02-26
K925721 KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE Eastman Kodak Company LMA Class II 1993-02-26
K925793 TELESHARE 910 Dejarnette Research Systems LLZ Class II 1993-02-26
K924445 BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY Control-X, Inc. IXY Class I 1993-02-19
K920351 PCX 650HF RADIOGRAPHIC X-RAY Control-X, Inc. IZO Class I 1993-02-12
K926083 NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES Biodan Medical Systems, Ltd. IYX Class I 1993-02-12
K925486 UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS. Aloka Co., Ltd. ITX Class II 1993-02-12
K923554 KODAK EKTASCAN Eastman Kodak Company IXW Class II 1993-02-12
K925646 SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS. Aloka Co., Ltd. IYO Class II 1993-02-12
K925009 2D TOF ANGIOGRAHY MEASURING FUNCTION Hitachi Medical Systems America, Inc. LNH Class II 1993-02-12
K926122 FLUOREX Toshiba America Medical Systems, In.C JAA Class II 1993-02-12
K920349 PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR Control-X, Inc. IZO Class I 1993-02-12
K921215 LASERSTAR IMAGER Frantz Imaging, Inc. LMC Class II 1993-02-05
K924444 B-4 FOUR-WAY RADIOGRAPHIC TABLE Control-X, Inc. IZZ Class II 1993-02-05
K924443 RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE Control-X, Inc. IZF Class II 1993-02-05
K922267 PHOTOPHONE(R) MULTI VIEW(TM) Image Data Corp. LLZ Class II 1993-02-02
K925845 VISTA HP/HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1993-02-02
K923077 ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION GE Medical Systems JAK Class II 1993-02-02
K924178 MEDVISION(TM) IMAGING SOFTWARE Evergreen Technologies, Inc. LMD Class I 1993-02-02
K925684 OLYMP-X,X-RAY GENERATOR Afp Imaging Corp. IZO Class I 1993-02-02
K925598 BUCKYMATIC AUTOMATIC CHEST FILM CHANGER Acoma Medical Imaging, Inc. KPX Class II 1993-02-01
K914583 TOSBEE Toshiba America Medical Systems, In.C IYD Class II 1993-01-28
K925330 SYSTEM, TOMOGRAPHIC, NUCLEAR Rjl Associates, LLC KPS Class II 1993-01-28
K925465 TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT Life Care Imaging LLZ Class II 1993-01-27
K924078 POLYDOROS C Siemens Medical Solutions USA, Inc. IZO Class I 1993-01-26
K923334 MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER Cook, Inc. IXA Class II 1993-01-26
K926069 WRIST TRACTION Octostop, Inc. KPR Class II 1993-01-21
K926056 9600 FLUOROSCOPIC IMAGING SYSTEM Oec-Diasonics, Inc. OXO Class II 1993-01-21
K924310 PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC GE Medical Systems LLZ Class II 1993-01-21
K924458 AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ Acoustic Imaging Technologies Corp. IYO Class II 1993-01-21
K925284 IMAGESSSHARE 910 Dejarnette Research Systems LMD Class I 1993-01-21
K922164 RAYTEL DIGITAL IMAGING SYSTEMS Olicon Imaging Systems, Inc. LMD Class I 1993-01-21
K923141 PHILIPS PRE-FILTER OPTION Philips Medical Systems, Inc. ITY Class I 1993-01-21
K925107 SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM Shimadzu Medical Systems LNH Class II 1993-01-15
K924980 CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH Endosonics Corp. ITX Class II 1993-01-15
K924489 SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST Siemens Medical Solutions USA, Inc. LNH Class II 1993-01-15
K924810 SIM/PLANT Columbia Scientific, Inc. JAK Class II 1993-01-15
K924639 NEW DETECTOR FOR TRANSCAM/POLARIS S315 Adac Laboratories IYX Class I 1993-01-15
K925097 VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING) Vortech Data, Inc. LMD Class I 1993-01-15
K923584 THERAPAX DXT 300 SERIES 3 Oldelft Corp. of America JAD Class II 1993-01-15
K924878 NEW DETECTOR OPTION Adac Laboratories IYX Class I 1993-01-15
K925569 AX-700LE AUTOMATIC X-RAY FILM PROCESSOR Alphatek Corp. IXW Class II 1993-01-15
K925212 GIOTTO PATIENT BED Gold Coast Imaging, Inc. IZH Class II 1993-01-15
K924423 MWX-7440 HIGH SPEED BUCKY Midwest X-Ray Equipment Co. KPX Class II 1993-01-15
K923870 3DTOF MRA Resonex, Inc. LNH Class II 1993-01-12
K925186 EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS Strichman Medical Equipment, Inc. KPS Class II 1993-01-12
K925133 DPD-510 THERAPEUTIC RADIATION DOSIMETER Scanditronix, Inc. IWB Class II 1993-01-04
K924879 EP 3000 Oec-Diasonics, Inc. JAA Class II 1993-01-04
K924708 CINENET CARDIAC IMAGE NETWORK Sony Medical Systems IZI Class II 1992-12-30
K920880 BRAINSCAN BRACHYTHERAPY MODULE Brainlab KXK Class II 1992-12-30

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