meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
39
Latest Decision
1985-04-10

Clearances · page 140 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K851011 HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR Hofmann X-Ray of America, Inc. IZO Class I 1985-04-10
K850823 SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR Philips Medical Systems (Cleveland), Inc. IZO Class I 1985-04-10
K850814 MODULAR X-RAY BARRIERS Victoreen, Inc. EAK Class I 1985-04-10
K844248 IR-192 IMPLANT Rads S.L., Inc. IWA Class II 1985-04-10
K850463 BASICAM COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. IYX Class I 1985-04-10
K850948 TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER D&R X-Ray Products, Inc. IXR Class II 1985-04-10
K850816 LEAD PLASTIC VIEWING PANELS Victoreen, Inc. EAK Class I 1985-04-10
K850959 EQUIPMENT SNAP KOVERS Advance Medical Designs, Inc. JAA Class II 1985-04-09
K850117 XMA 325 (X-RAY GENERATOR) Summit Industries, Inc. IZO Class I 1985-04-09
K850118 XMA INTEGRATED TABLE Summit Industries, Inc. IXQ Class II 1985-04-09
K842687 BIOMEDICS BLADDER SCANNER Biomedics ITX Class II 1985-04-08
K850027 MEDITECH EUROSCANNER M250 Stuart Medical, Inc. JAK Class II 1985-04-04
K850580 DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 Elscint, Inc. IYO Class II 1985-04-03
K843922 OSTEON BONE MINERAL ANALYZER Osteon, Inc. KGI Class II 1985-04-02
K850071 TECA MF-20 MICROVASCULAR DOPPLER Teca, Inc. IYN Class II 1985-04-02
K850116 BETASONIC III Teknar, Inc. IYO Class II 1985-03-29
K850422 ATS ACOUSTIC STANDOFF - WATER BAG Ats Laboratories, Inc. ITX Class II 1985-03-27
K850208 FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS Syncor Intl. Corp. IXD Class I 1985-03-26
K850163 IRIDIUM 192 WIRES Syncor Intl. Corp. IWA Class II 1985-03-26
K850726 WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD Syncor Intl. Corp. IWA Class II 1985-03-26
K850397 ORBITOR II COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. IYX Class I 1985-03-26
K850434 CS137 SEALED SOURCES Syncor Intl. Corp. KXK Class II 1985-03-26
K850614 SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY S & S X-Ray Products, Inc. IZH Class II 1985-03-26
K850125 MULTI-SIZE CASSETTE HOLDER Philips Medical Systems (Cleveland), Inc. IXY Class I 1985-03-26
K844375 EIGEN FLORO-STOR FS-100 Eigen Video JAA Class II 1985-03-26
K850571 I-125 IMPLANT GUN Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1985-03-26
K850197 KELLER CEPHALOMETRIC DEVICE Gary D. Keller IWY Class I 1985-03-22
K850421 CINE RADIOGRAPHIC FILM PROCESSOR M-45CR The Allen Products Co. IXX Class II 1985-03-22
K844298 ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM Adac Laboratories LLZ Class II 1985-03-01
K844037 DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER Toshiba Medical Systems LLZ Class II 1985-03-01
K843443 EDEC-100 Electromed Intl., Ltd. IZO Class I 1985-03-01
K844218 TOMOGRAPHIC GANTRY General Electric Co. IYX Class I 1985-03-01
K844549 HEAD-SPINE STABILIZER HSS-1 Imaging Accessories, Inc. IWY Class I 1985-03-01
K845030 CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1985-02-26
K844714 SELECTRON LDR SELECTRON LOW DOSE RATE Radiochemical Co. JAQ Class II 1985-02-26
K844317 DMI CONSOLE Dimensional Medicine, Inc. LLZ Class II 1985-02-26
K843696 OPHTHALMIC A-SCAN A-2000 SONOME Sonomed Technology, Inc. IYO Class II 1985-02-26
K843205 GL ULTRASOUND Z/SL 8300 Gl Ultrasound , Ltd. IYO Class II 1985-02-25
K844128 EUB-40 Hitachi Medical Corp. of America JAF Class II 1985-02-25
K844189 LINEAR SCANNER PROBE ELSCINT LTD. TL-35 Elscint, Inc. IYP Class I 1985-02-25
K844424 INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10 Varian Assoc., Inc. JAD Class II 1985-02-21
K844337 X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY Quality X-Ray Manufacturing, Inc. IYB Class I 1985-02-21
K850184 MEDICAL MULTI-IMAGE CAMERA-676 Dunn Instruments, Inc. LMC Class II 1985-02-21
K844554 BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG Belmont Equipment Corp. IWZ Class I 1985-02-21
K844293 AUTO DII MULTI FREQUENCY Technicare Corp. IYN Class II 1985-02-13
K842407 PULSED DOPPLER OPTION, CONTINU-WAVE General Electric Co. IYN Class II 1985-02-13
K843933 VINGMED DS100 DOPPLER FLOWMETER Vingmed, Inc. JAF Class II 1985-02-13
K843920 FLUOROSCAN/TM BY HEALTHMATE Healthmate, Inc. JAA Class II 1985-02-07
K844683 IMAGEN CHLAMYDIA TEST Boots-Celltech Diagnostics, Inc. IWP Class I 1985-02-06
K844404 IREX PS, PORTABLE SCANNER AND 118 Irex Corp. IYO Class II 1985-02-04
K844783 DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER Adac Laboratories LLZ Class II 1985-02-01
K844784 DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER Adac Laboratories LLZ Class II 1985-02-01
K844180 THE MCP-70-SE SYSTEM Ellis Pharmaceutical Consulting, Inc. KQA Class II 1985-02-01
K844477 STORZ CORNEO-SCAN II CS2000 Storz Instrument Co. IYO Class II 1985-01-23
K844449 HIGH RESOLUTION 5 MHZ LINEAR ARRAY Siemens Medical Solutions USA, Inc. IYO Class II 1985-01-23
K844472 CIVCO SCAN DRAPE CIVCO Medical Instruments Co., Inc. IYO Class II 1985-01-23
K844132 MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER Sigma Teleproducts, Inc. LMB Class I 1985-01-22
K843640 XENON XE 127/XE 133 GAS DISPENSER Mallinckrodt Critical Care IYT Class II 1985-01-14
K843891 DOPSCAN PLUS DS1060 Carolina Medical Electronics IYO Class II 1985-01-09
K842757 ULTRASCAN DIGITAL B CooperVision, Inc. IYO Class II 1985-01-09
K843917 FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL Afp Imaging Corp. JAA Class II 1985-01-03
K843972 ANGIOPLUS-S Oec-Diasonics, Inc. JAA Class II 1985-01-03
K843320 RT-50 General Electric Co. IYO Class II 1984-12-27
K844496 MEDIPART XENON BREATHING KIT MP-01XM Medipart Jerry Alexander IYT Class II 1984-12-24
K844495 MEDIPART XENON BREATHING KIT MP-02XM Medipart Jerry Alexander IYT Class II 1984-12-17
K844160 VENTIBOX Syncor Intl. Corp. KPY Class I 1984-12-17
K843927 CT 9000 General Electric Co. JAK Class II 1984-12-17
K843716 NUCLEAR 700 MEDICINE MECHANICAL POSIT- Technicare Corp. IYX Class I 1984-12-17
K843926 PRESTILIX 1690 Cgr Medical Corp. IXR Class II 1984-12-17
K843349 ND3100 VIDEO IMAGER Nuclear Data, Inc. LMB Class I 1984-12-17
K843928 COUNTERBALANCED VERTICAL CASSETTE HOLDER Poersch Metal Mfg. Co. IYB Class I 1984-12-17
K842900 PHILIPS SDR 1200 Philips Medical Systems, Inc. IYO Class II 1984-12-13
K843573 CIVCO-SUPER SCAN/BIOPSY GUIDE CIVCO Medical Instruments Co., Inc. ITX Class II 1984-12-13
K842880 MECHANICAL SECTOR PROBE 4 MHZ DFM General Electric Co. IYO Class II 1984-12-10
K842408 IREX 730 MECHANICAL SECTOR SCANNER Irex Corp. JAF Class II 1984-11-29
K842777 AUTOFOCUS DUAL ELEMENT PROBE Technicare Corp. IYO Class II 1984-11-29
K843502 3M LASER IMAGER 3M Company LMC Class II 1984-11-29
K843437 MEI MAMMOGRAPHY SYS MX-2049 Moti Enterprises, Inc. IZH Class II 1984-11-27
K843335 FLOOR MOUNTED X-RAY TUBESTAND Medicor USA , Ltd. IYB Class I 1984-11-27
K843340 PORTA-STAT Porta-Stat, Inc. IWY Class I 1984-11-27
K843366 SUPERPETT Scanditronix, Inc. KPS Class II 1984-11-21
K843558 DELTANODE, MEGA DELTA, DELTA LINK- Computer Design & Applications, Inc. IYX Class I 1984-11-13
K843288 KETRONIC MEDAX - N Ketronic, Inc. IYX Class I 1984-11-08
K842217 IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS Micro Consultants, Inc. JAA Class II 1984-11-08
K843235 STENOSCOP Cgr Medical Corp. JAA Class II 1984-11-08
K842191 DIGISTORE 50 Vas Corp. JAA Class II 1984-10-25
K843582 MULTI-FORMAT FILM CAMERA Bfi- Medical Waste Systems LMC Class II 1984-10-25
K842376 ULTRAMARK 4 ULTRASOUND SYS Advanced Technology Laboratories, Inc. IYO Class II 1984-10-05
K842093 MK 700 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1984-09-27
K842897 MEDICAL DIAG. ULTRASOUND INSTR. 77065 Hewlett-Packard Co. IYO Class II 1984-09-25
K843167 SONIC AID GREEN ULTRASOUND GEL Wpc Brands, Inc. IYO Class II 1984-09-19
K842811 ULTRASYSTEM LINSCAN PROBE Kelley Development Corp. IYO Class II 1984-09-17
K843244 LIGHT BEAM COLLIMATOR Dealers X-Ray Co., Inc. IZW Class II 1984-09-14
K842127 AMERICAN MEDICAL OPTICS IMAGING SYS American Medical Optics IYO Class II 1984-09-07
K843192 APR MOBILE Philips Medical Systems (Cleveland), Inc. IZL Class II 1984-09-05
K841997 CT 9800 General Electric Co. JAK Class II 1984-09-04
K842615 CLARK PRECISION BLOCK CUTTER, COOLING Clark Research and Development, Inc. IXI Class II 1984-09-04
K842895 WBA - I.R.I.S. Siemens Gammasonics, Inc. JAM Class I 1984-08-27
K843176 KODAK X-OMATIC RADIATION THERAPY CASS Eastman Kodak Company IXA Class II 1984-08-27
K842055 PICKER ARTIS ULTRASOUND IMAGING SYS Philips Medical Systems (Cleveland), Inc. IYN Class II 1984-08-24

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