meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
43
Latest Decision
1985-10-31

Clearances · page 139 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K851860 DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM Diasonics, Inc. IYO Class II 1985-10-31
K853459 XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM Xerox Medical Systems IXK Class II 1985-10-30
K853756 DYNAMIC CARDIAC PHANTOM 74-347 Victoreen, Inc. IXY Class I 1985-10-29
K853928 UNIVERSAL STAND FOR FILM CHANGER Canon USA, Inc. KPX Class II 1985-10-28
K854251 THE CSE FILM CHANGER SYSTEM Changer Service & Engineering, Inc. IZP Class II 1985-10-28
K853349 VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST Varian Assoc., Inc. KPQ Class II 1985-10-28
K852410 MEVAPLAN AND SOMADOS Siemens Medical Solutions USA, Inc. KPQ Class II 1985-10-28
K854085 OMNI PLANE SYSTEM Xre Corp. IXR Class II 1985-10-28
K852974 ACUSON RADIOLOGY DOPPLER ACCESSORY Acuson Computed Sonography ITX Class II 1985-10-24
K852510 COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS Image Analysis, Inc. KGI Class II 1985-10-18
K852509 QCT-BONE MINERAL PHANTOM Image Analysis, Inc. KGI Class II 1985-10-18
K850417 INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK Impact Systems Corp. LMD Class I 1985-10-16
K853983 CANON X-RAY 35MM CINE CAMERA CSI-35 Canon USA, Inc. IZJ Class II 1985-10-16
K853087 STORZ SOLID-STANDOFF PACHYMETRY PROBE Storz Instrument Co. IYO Class II 1985-10-16
K853984 CANON X-RAY IMAGE DISTRIBUTOR Canon USA, Inc. JAA Class II 1985-10-16
K852804 MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS Medcyc. Corp. IWL Class II 1985-10-15
K852865 OPTICAL DISC UNIT General Electric Co. JAK Class II 1985-10-10
K853175 REI-90/15 Radiological Engineering, Inc. IXR Class II 1985-10-10
K853753 DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302 Victoreen, Inc. KPR Class II 1985-10-02
K851895 POLYGEL ULTRASOUND GEL Parker Laboratories, Inc. IYO Class II 1985-09-27
K852528 BONE DENSITY CT PHANTOM Computerized Imaging Reference Systems, Inc. IXG Class I 1985-09-26
K850838 CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW Clinicomp, Inc. KPT Class II 1985-09-26
K852952 TRAUMA STAND Xre Corp. IYB Class I 1985-09-26
K851240 SONOLAYER-L SAL-32B Toshiba Medical Systems ITX Class II 1985-09-23
K851526 CONVEX PROBE, PVE-393M Toshiba Medical Systems ITX Class II 1985-09-23
K850416 TOMOMATIC 564 M.I.D., Inc. KPS Class II 1985-09-20
K851301 TARGET CAT#B7850AA & B7850AB & B7850B General Electric Co. LHN Class II 1985-09-20
K852768 ORALIX PANORAMIC D.C. Philips Medical Systems, Inc. IZF Class II 1985-09-19
K852570 5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517 Siemens Medical Solutions USA, Inc. IYO Class II 1985-09-19
K852571 3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509 Siemens Medical Solutions USA, Inc. IYO Class II 1985-09-19
K852907 SIEMENS MEVATRON ME Siemens Medical Laboratories, Inc. LHN Class II 1985-09-19
K851807 RT2600(115V)(220/240V) #H4008A & H4008AE General Electric Co. IYO Class II 1985-09-19
K853682 MOUNT TUBE RADIOGRAPHIC X-Ray Systems IYB Class I 1985-09-19
K852572 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 Siemens Medical Solutions USA, Inc. JAF Class II 1985-09-19
K851036 SONOLAYER-V, SSA-90A Toshiba Medical Systems ITX Class II 1985-09-17
K844686 OPHTHASCAN B Biophysic Medical, Inc. IYO Class II 1985-09-13
K851199 MEDIPART LUNG AEROSOL KIT MP-1012A-M Medipart Jerry Alexander IYT Class II 1985-09-10
K851200 MEDIPART LUNG AEROSOL KIT MP-1024A Medipart Jerry Alexander IYT Class II 1985-09-10
K851198 MEDIPART LUNG AEROSOL KIT MP-1012A Medipart Jerry Alexander IYT Class II 1985-09-10
K851201 MEDIPART LUND AEROSOL KIT MP-1024A-M Medipart Jerry Alexander IYT Class II 1985-09-10
K844184 D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB D.R.G. IYO Class II 1985-09-06
K852239 POSICAM TM(MODEL 3.2,4.3,6.5) Position Corp. KPS Class II 1985-09-03
K852349 RHYNOSTAT H-12 & V-22 Remesta Medical Corp. KPR Class II 1985-09-03
K850815 RADIOISOTOPE CALIBRATOR MODEL 34-062 Victoreen, Inc. KPT Class II 1985-08-21
K852023 CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 Syncor Intl. Corp. KXK Class II 1985-08-21
K850433 CESIUM 137 ENDOMETRIAL SOURCE Syncor Intl. Corp. KXK Class II 1985-08-21
K850837 MEDIPART FACE MASK & FILTER MP-30XM-I Medipart Jerry Alexander IYT Class II 1985-08-19
K850836 MEDIPART FACE MASK MP-XM-I Medipart Jerry Alexander IYT Class II 1985-08-19
K852132 MODEL 21225A CW COPPLER/IMAGING TRANSDUCER Hewlett-Packard Co. ITX Class II 1985-08-19
K850382 IRIDIUM SEEDS Radiation Safety & Nuclear Products, Inc. IWA Class II 1985-08-15
K852549 SONORANGER Ausonics Pty , Ltd. IYO Class II 1985-08-14
K851982 KITECKO ULTRASOUND STANDOFF PAD 3M Company IYO Class II 1985-08-14
K852353 DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM Thomson-Cgr Medical Corp. IXI Class II 1985-08-07
K853056 RESPIR GARD-II FACE MASK CORRUGATED TUBING Marquest Medical Products, Inc. IYT Class II 1985-08-07
K851813 THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE Victoreen, Inc. KPQ Class II 1985-08-07
K850977 COMPUTE RX-PLAN Medicalibration KPQ Class II 1985-07-26
K852693 XEN-REX I Nuclear Pharmacy, Inc. IYT Class II 1985-07-24
K852634 MICRO-FOCUS 50 CABINET X-RAY Micro-Focus Imaging., Inc. MWP Class II 1985-07-19
K844119 MAMMOGRAPH III American Medical Imports, Inc. IZH Class II 1985-07-19
K851041 ADAC MODELS XL-PLAN 23 & XL-PLAN 73 Adac Laboratories IYE Class II 1985-07-18
K852160 RADIOLOGICAL MARKING PEN Truett Laboratories, Inc. JAC Class I 1985-07-18
K852089 SATURN NUCLEAR MEDICINE COMPUTER SYSTEM Technicare Corp. IYX Class I 1985-07-18
K844620 BDS-3 BEAM DATA SCANNER Varian Assoc., Inc. LHO Class I 1985-07-01
K845007 RFA-7 RADIATION FIELD ANALYZER Varian Assoc., Inc. LHO Class I 1985-07-01
K851685 DIGITAL GAMMA CAMERA GCA 601 E Toshiba Medical Systems JWM Class II 1985-06-14
K850885 STARCAM DATA ACQUISITION & PROCESSING SYS H3300C General Electric Co. JWM Class II 1985-06-06
K851812 DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 Victoreen, Inc. IXF Class I 1985-06-05
K851687 JUMBO DIGITAL GAMMACAMERA GCA-90B Toshiba Medical Systems JWM Class II 1985-06-05
K851440 RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR Summit Industries, Inc. IXY Class I 1985-06-05
K851686 DIGITAL GAMMA CAMERA GCA 501S Toshiba Medical Systems JWM Class II 1985-06-05
K851031 EXPOSCOP MOBILE IMAGING SYSTEM Euro-Electronics, Inc. JAA Class II 1985-05-28
K851811 SLIT CAMERA MODEL 07-624 Victoreen, Inc. IXH Class I 1985-05-28
K842094 XMC-S TUBESTAND XMT-S TABLE XMH-NTWALL X-Ray Mfg. & Sales, Inc. IXQ Class II 1985-05-24
K851653 VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP Varian Assoc., Inc. KPQ Class II 1985-05-23
K844031 SONOMED TECH OPHTHALMIC B-SCAN B-3000 Sonomed Technology, Inc. ITX Class II 1985-05-22
K851696 AUSONICS 150 Ausonics Pty , Ltd. IYO Class II 1985-05-22
K851644 SPECTRUM 150 DT Raytheon Medical Systems IYX Class I 1985-05-21
K851067 CANON X-RAY FILM CHANGER CFC-U1 Canon USA, Inc. KPX Class II 1985-05-21
K850415 CRONEX KEVLAR CASSETTE E.I. Dupont DE Nemours & Co., Inc. IXA Class II 1985-05-14
K850198 FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG Summit Industries, Inc. IYB Class I 1985-05-14
K850543 THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY Atomic Energy of Canada IWB Class II 1985-05-10
K850455 QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM Xre Corp. IZI Class II 1985-05-06
K850367 MEDIPART XENON BREATHING KIT MP-02XM-I Medipart Jerry Alexander IYT Class II 1985-04-30
K850366 MEDIPART XENON BREATHING KIT MP-OIXM-I Medipart Jerry Alexander IYT Class II 1985-04-30
K850330 ANGIOTEC SC 1221 SCAN CONVERTER Angiotec LMA Class II 1985-04-30
K844916 MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER Hoffrel Instruments, Inc. IYO Class II 1985-04-22
K850080 DIGITAL IMAGE PROCESSOR FP-2C Eigen Video LLZ Class II 1985-04-19
K850290 ULTRASOUND GEL Litton Datamedix IYO Class II 1985-04-18
K843994 AUSONICS 357 Ausonics Pty , Ltd. IYO Class II 1985-04-18
K850678 AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL Fairchild Medical Systems, Inc. IZL Class II 1985-04-18
K843971 AUSONICS 150 Ausonics Pty , Ltd. IYO Class II 1985-04-18
K844835 ND2100 SPINE SCANNER Nuclear Data, Inc. KGI Class II 1985-04-18
K844299 CORNEOMAP 4500 Radionics Medical, Inc. IYO Class II 1985-04-18
K844926 HEAD-SPINE STABILIZER HSS-1 Imaging Accessories, Inc. JAK Class II 1985-04-16
K843708 ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS Adac Laboratories LLZ Class II 1985-04-16
K850173 AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT Ausonics Pty , Ltd. IZH Class II 1985-04-16
K844766 ND1100 BONE DENSITY SCANNER Nuclear Data, Inc. KGI Class II 1985-04-16
K850478 PLUS 1 Dymax Corp IYO Class II 1985-04-15
K844393 GL ULTRASOUND SECTOR 170 Gl Ultrasound , Ltd. IYO Class II 1985-04-10
K850813 MOBILE LEAD PLASTIC X-RAY BARRIERS Victoreen, Inc. IWX Class I 1985-04-10

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