meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
32
Latest Decision
1992-04-02

Clearances · page 123 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920678 ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER Interspec, Inc. ITX Class II 1992-04-02
K913798 SONOLAYER ALPHA, MODEL SSH-140A Toshiba America Medical Systems, In.C ITX Class II 1992-04-01
K920097 MRT-50 QD HEAD COIL Toshiba America Mri, Inc. LNH Class II 1992-03-31
K920125 MRT-50 SPINE COIL Toshiba America Mri, Inc. LNH Class II 1992-03-31
K920455 THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.) S & S Inficon, Inc. IYE Class II 1992-03-31
K920115 MEDISCINT Oakfield Instruments, Ltd. IZD Class I 1992-03-30
K920310 SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE Siemens Gammasonics, Inc. LMD Class I 1992-03-30
K920041 ADAC XL-PLAN-PC Adac Laboratories IYE Class II 1992-03-30
K920309 SIENET DIAGNOSTIC REPORTING CONSOLE Siemens Gammasonics, Inc. LLZ Class II 1992-03-20
K914825 1-125 ENDOSEED Endo Technic Corp. KXK Class II 1992-03-19
K912327 DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. Davis Lead Aprons, Inc. KPY Class I 1992-03-18
K912326 DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS Davis Lead Aprons, Inc. KPY Class I 1992-03-18
K912378 DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS Davis Lead Aprons, Inc. KPY Class I 1992-03-18
K915873 MOS-III Sherman Ophthalmic Supplies, Inc. LNH Class II 1992-03-16
K915260 MRI ULTRAVIEW A&E Specialty Fabricators LNH Class II 1992-03-16
K915754 16 BIT A/D Resonex, Inc. LNH Class II 1992-03-16
K915657 MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28 Bruker Medical Imaging, Inc. LNH Class II 1992-03-13
K913472 LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM Baxter Healthcare Corp ITX Class II 1992-03-13
K920199 HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST Philips Medical Systems (Cleveland), Inc. LNH Class II 1992-03-06
K914834 VORTECH 3M NETWORK PRINTING Vortech Data, Inc. LMC Class II 1992-03-06
K920558 KONICA DIRECT DIGITIZER KD-1000 Konica Corp. KPR Class II 1992-03-06
K913908 OMNITRON GYN APPLICATOR SYSTEM Omnitron Intl., Inc. JAQ Class II 1992-03-06
K920159 MOBILE MRP-7000 Hitachi Medical Systems America, Inc. LNH Class II 1992-03-05
K914209 MODEL 310GE-64: WHOLE VOLUME NECK COIL Medical Advances, Inc. LNH Class II 1992-03-05
K915436 BLADDERSCAN BVI 2500 Diagnostic Ultrasound Corp. IYO Class II 1992-03-03
K914728 KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM Eastman Kodak Company LMB Class I 1992-03-02
K903562 CW DOPPLER 2.25 MHZ PROBE Diasonics, Inc. ITX Class II 1992-03-02
K914578 RTS TECHNOLOGY MODELS 721,722,723,724 Rts Technology, Inc. JAQ Class II 1992-02-28
K914366 MEDRAD PATHFINDER HR ROADMAPPING SYSTEM Medrad, Inc. LLZ Class II 1992-02-27
K914747 XENON CIRCUIT Gibeck, Inc. IYT Class II 1992-02-27
K914404 ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT Lunar KGI Class II 1992-02-27
K915535 FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM Lunar KGI Class II 1992-02-27
K913941 PSG(TM) 20 GUAGE DOPPLER NEEDLE Peripheral Systems Group ITX Class II 1992-02-27
K914305 SYTEC DENTASCAN General Electric Co. JAK Class II 1992-02-27
K914417 MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE Med-Vac, Inc. IXR Class II 1992-02-27
K915253 IR-192 IMPLANT, MODIFICATION Omnitron Intl., Inc. IWA Class II 1992-02-27
K915644 CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS Nuccardiac Software, Inc. KPS Class II 1992-02-27
K915552 INSTRUMENTARIUM MEGA4 Instrumentarium Imaging, Inc. LNH Class II 1992-02-27
K914807 APEX HELIX - A Elscint, Inc. KPS Class II 1992-02-27
K914444 XPR PRINTER REDUNDANCY Vortech Data, Inc. LMD Class I 1992-02-27
K915305 OPTION U1 FOR THE DPS-PLUS SYSTEM Adac Laboratories LLZ Class II 1992-02-26
K914191 XLP NETWORK PRINTING Vortech Data, Inc. LMD Class I 1992-02-18
K915579 3D PROCESSING OPTIONS FOR GYREX Elscint, Inc. LNH Class II 1992-02-18
K915623 SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE Shimadzu Medical Systems JAK Class II 1992-02-14
K915601 GYREX 2T-DLX Elscint, Inc. LNH Class II 1992-02-14
K914351 CLINITRON C-10 Ssi Medical Services, Inc. IXQ Class II 1992-02-14
K920031 KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE Eastman Kodak Company JAC Class I 1992-02-12
K915405 P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS) Precise Optics Photo Medic Equipment, Inc. JAA Class II 1992-02-04
K915748 AVIVA MAMMOGRAPHIC X-RAY SYSTEM Elscint, Inc. IZH Class II 1992-02-04
K914376 DXS DIGITAL X-RAY SUBTRACTION Philips Medical Systems (Cleveland), Inc. IZI Class II 1992-02-04
K913732 MAMMOGRAPHIC X-RAY SYSTEM Lorad Medical Systems, Inc. IZH Class II 1992-02-03
K912996 MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE Continental X-Ray Corp. IXR Class II 1992-02-03
K913067 DGH-4000 A-SCAN/PACHYMETER Dgh Technology, Inc. IYO Class II 1992-01-31
K915598 SPECIAL PURPOSE COILS FOR GYREX V Elscint, Inc. LNH Class II 1992-01-31
K915667 MODEL H170 PEDIATRIC CHEST X-RAY UNIT H.L. Lyons Co. IXY Class I 1992-01-31
K910850 PSF-50ET Toshiba America Medical Systems, In.C ITX Class II 1992-01-29
K913886 SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER Sony Medical Electronics Co. JAA Class II 1992-01-24
K914414 VIDEO FLUOROSCOPE Raymax Medical Corp. JAA Class II 1992-01-24
K915853 TANGENT V Fischer Imaging Corp. IXR Class II 1992-01-24
K915542 QCA PLUS Sanders Data Systems, LLC LLZ Class II 1992-01-24
K913673 VECTRA MAGNETIC RESONANCE SYSTEM General Electric Co. LNH Class II 1992-01-23
K913485 CT SYTEC 8000 General Electric Co. JAK Class II 1992-01-23
K915395 MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY Siemens Medical Solutions USA, Inc. LNH Class II 1992-01-23
K914808 LEKSELL GAMMAPLAN (LGP) Elekta Instruments, Inc. IWB Class II 1992-01-23
K915199 STORZ IMAGING SYSTEM Fischer Imaging Corp. IZI Class II 1992-01-23
K915541 SPECT TABLE, MODEL #056-760 Atomic Products Corp. IYZ Class I 1992-01-17
K915592 PEGASUS LATERAL CARDIAC POSITIONER Fischer Imaging Corp. JAA Class II 1992-01-13
K914446 UROVIEW 2000, MODIFICATION Oec-Diasonics, Inc. JAA Class II 1992-01-10
K915237 PHILIPS PCR-ACE SYSTEM Philips Medical Systems, Inc. LLZ Class II 1992-01-09
K912776 CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND Cardio Metrics, Inc. ITX Class II 1992-01-09
K912819 SC1150 CW/PD Pie Medical Equipment B.V. IYN Class II 1992-01-09
K915227 GEN-X 800/500 Swiss Ray Medical Systems IZO Class I 1992-01-09
K915339 GEN-X 800/300 Swissray Finatech, Inc. IZO Class I 1992-01-09
K915232 GRUNDIG ELECTRONICS VARIOUS MODELS Perkins Mfg. Co. IZI Class II 1992-01-09
K913418 SENOGRAPHE DMR/SMR/DM General Electric Co. IZH Class II 1992-01-06
K915156 I-125 SEEDS CODE: 6702 Medi-Physics Inc. Dba Nycomed Amersham Imaging KXK Class II 1992-01-06
K914143 KODAK X-OMAT 480 RA PROCESSOR Eastman Kodak Company IXW Class II 1992-01-06
K915094 VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM Vortech Data, Inc. LMB Class I 1991-12-27
K915112 MAGNETOM 42 SP,63 SP,IMPACT Siemens Medical Solutions USA, Inc. LNH Class II 1991-12-27
K913770 ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION General Electric Co. LNH Class II 1991-12-27
K913222 OPTIMA Olympic Controls Corp. IZO Class I 1991-12-20
K913845 PHILIPS MAMMODIAGNOST BC Philips Medical Systems, Inc. IZH Class II 1991-12-20
K911116 INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST Interson Corp. ITX Class II 1991-12-20
K913612 SEQUENCER Impac Medical Systems, Inc. IYE Class II 1991-12-19
K914582 KODAK EKTASCAN 1120 LASER PRINTER Eastman Kodak Company LMC Class II 1991-12-19
K915413 CAT-250B Toshiba America Medical Systems, In.C IZZ Class II 1991-12-19
K912799 EAGLE SYSTEM Marquette Electronics, Inc. LMC Class II 1991-12-18
K905488 DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN Ausonics Pty , Ltd. LMB Class I 1991-12-18
K913746 SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM Peripheral Systems Group ITX Class II 1991-12-17
K911113 INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST Interson Corp. ITX Class II 1991-12-17
K911115 INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM Interson Corp. ITX Class II 1991-12-17
K911117 INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST Interson Corp. ITX Class II 1991-12-17
K913641 SOPHY NXT Sopha Medical Systems, Inc. KPS Class II 1991-12-17
K912088 BIOPSY ACCESSORIES FOR ULTRASOUND PROBES Biosound, Inc. ITX Class II 1991-12-05
K914114 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) Resonex, Inc. LNH Class II 1991-12-04
K914013 SIEMENS SI-400 Siemens Ultrasound, Inc. IYO Class II 1991-12-02
K914944 BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC Bennett X-Ray Corp. IYB Class I 1991-12-02
K914328 MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. IZH Class II 1991-12-02
K912361 SI-450/ILUS (INTRALUMINAL ULTRASOUND) Siemens Ultrasound, Inc. ITX Class II 1991-12-02
K915088 KODAK MIN-R IDENTIFICATION CAMERA Eastman Kodak Company JAC Class I 1991-12-02

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