meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
38
Latest Decision
1986-04-17

Clearances · page 138 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854478 REI-90/90 RADIOGRAPHIC TABLE Radiological Engineering, Inc. IXR Class II 1986-04-17
K860736 FISCHER IMAGING FX325R X-RAY GENERATOR Fischer Imaging Corp. IZO Class I 1986-04-17
K861252 NON-CIRCULAR ORBITING OPTION Siemens Gammasonics, Inc. KPS Class II 1986-04-16
K860469 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS Victoreen, Inc. KPZ Class II 1986-04-16
K854810 FC-1000 FLUOROSCOPIC IMAGING COMPUTER Inficon Leybold-Heraeus, Inc. LLZ Class II 1986-04-15
K854389 NIDEK US-1600 A-SCAN Nidek, Inc. IYO Class II 1986-04-08
K860849 MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM Marx Pland IWB Class II 1986-04-08
K860620 SHAMPAINE RADI-OP MODEL 1700RC Smith & Nephew, Inc. KXJ Class II 1986-04-08
K855002 KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM Eastman Kodak Company LLZ Class II 1986-04-07
K861225 KODAK AUTOMIXER II Eastman Kodak Company IXW Class II 1986-04-07
K860504 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM Victoreen, Inc. ITY Class I 1986-04-04
K861019 CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD Phase One Disign Co. EAK Class I 1986-04-02
K860913 SIREGRAPH D Siemens Medical Solutions USA, Inc. IXR Class II 1986-04-01
K860761 MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06 Lenzar Optics Corp. LMC Class II 1986-04-01
K860494 7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T Ausonics Pty , Ltd. ITX Class II 1986-03-26
K854667 7.5 MHZ LINEAR ARRAY SONOLINE PROBE Siemens Medical Solutions USA, Inc. IYO Class II 1986-03-20
K854668 5.0 MHZ LINEAR ARRAY SONOLINE PROBE Siemens Medical Solutions USA, Inc. IYO Class II 1986-03-20
K860606 RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM Bionix Corp. LHN Class II 1986-03-20
K860691 KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA Eastman Kodak Company LMC Class II 1986-03-13
K853147 SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY Scano, Inc. IYO Class II 1986-03-13
K860797 MEDICAL X-RAY FILM India-America Trading Co. IWZ Class I 1986-03-13
K855124 CONVEX PROBE, PVE-382M Toshiba Medical Systems IYO Class II 1986-03-12
K854555 GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT Gl Ultrasound , Ltd. IYO Class II 1986-03-12
K852686 SONOLINE CD Siemens Medical Solutions USA, Inc. IYO Class II 1986-03-10
K860061 OCULAB BIOMETRICPEN Oculab, Inc. IYO Class II 1986-03-10
K860062 OCULAB PACHPEN Oculab, Inc. IYO Class II 1986-03-10
K852346 XISCAN MODEL 1000 Xi Tech JAA Class II 1986-03-10
K854407 DIGIRAD REUSABLE IMAGE MEDIA Digirad Corp. LQA Class I 1986-03-10
K854203 TEC 2720 MAMEX DC MAG Tecnomed, Inc. IZH Class II 1986-03-06
K860129 ISO-MAMMO Philips Medical Systems (Cleveland), Inc. IZH Class II 1986-03-06
K860755 KODAK MIN-R FAST SCREEN SO-459 Eastman Kodak Company EAM Class I 1986-03-06
K860666 KODAK X-OMAT PROCESSOR, MODEL ME-3 Eastman Kodak Company IXW Class II 1986-03-06
K860754 KODAK T-MAT M FILM SO-245 Eastman Kodak Company IXA Class II 1986-03-06
K854110 KEITHLEY MODEL 75100 & 75200 Keithley Instruments, Inc. KPR Class II 1986-03-06
K854787 ACUSON L538 TRANSDUCER Acuson Computed Sonography ITX Class II 1986-03-03
K854743 2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE Johnson & Johnson Professionals, Inc. IYO Class II 1986-02-28
K854969 CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) Cilco, Inc. IYO Class II 1986-02-27
K853739 SONOLAYER SAL-55A/55AS Toshiba Medical Systems IYO Class II 1986-02-24
K854609 MEVAMATIC 3 Siemens Medical Laboratories, Inc. JAD Class II 1986-02-21
K860454 BASICAM S COUNTER BALANCE CAMERA Siemens Gammasonics, Inc. IXY Class I 1986-02-21
K853966 ACUSON L312 TRANSDUCER Acuson Computed Sonography ITX Class II 1986-02-20
K853702 ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN Johnson & Johnson Professionals, Inc. IYO Class II 1986-02-13
K853737 VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) Capintec, Inc. IYY Class I 1986-02-13
K854933 SANDHILL ELECTRONIC CALIPER Sandhill IXC Class I 1986-02-12
K855161 UPRIGHT BUCKY STAND/MOUNT X-Ray Systems KPR Class II 1986-02-12
K854410 VERIFLEX Old Delft Corp. of America KPZ Class II 1986-02-12
K854459 TBX MEDICAL X-RAY TABLE Gendex Corp. IXJ Class I 1986-02-12
K854429 ACUSON NEEDLE GUIDE SYSTEM Acuson Computed Sonography ITX Class II 1986-02-07
K852609 MEVASSIST(SETUP CONTROLLER) Magus Microcontrollers, Inc. IYE Class II 1986-02-06
K855052 TABLE RADIOGRAPHIC FIXED X-Ray Systems IXQ Class II 1986-02-06
K852862 CORNEO-GAGE TWO Sonogage, Inc. IYO Class II 1986-01-30
K860193 PORTALCAST Diacor, Inc. IXI Class II 1986-01-30
K855063 UNIVERSAL PATIENT CHAIR UNI 2000X Siemens Medical Solutions USA, Inc. JAI Class II 1986-01-30
K852648 STARPORT MODEL H3300AA General Electric Co. IYX Class I 1986-01-30
K860203 TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR Tingle X-Ray Products, Inc. IZO Class I 1986-01-30
K854328 MEDEX X-RAY TABLE Philips Medical Systems (Cleveland), Inc. KXJ Class II 1986-01-28
K853946 SONOLINE LX Siemens Medical Solutions USA, Inc. IYO Class II 1986-01-16
K844112 MYOPACH ULTRASONIC PACHOMETER Myocure, Inc. IYO Class II 1986-01-16
K854785 ACUSON AL558 TRANSDUCER Acuson Computed Sonography ITX Class II 1986-01-15
K854786 ACUSON BL538 TRANSDUCER Acuson Computed Sonography ITX Class II 1986-01-15
K854788 ACUSON AL538 TRANSDUCER Acuson Computed Sonography ITX Class II 1986-01-15
K852542 PALLADIUM SEED MODEL 100 Nuclear Medicine, Inc. IWI Class II 1986-01-14
K853008 SONOLINE SL-2(ULTRASOUND SCANNER) Siemens Medical Solutions USA, Inc. IYO Class II 1986-01-13
K853671 BEAMSCAN Victoreen, Inc. KPQ Class II 1986-01-10
K852842 SELECTRON HDR REMOTE AFTERLOADER Nucletron-Oldelft Corp. JAQ Class II 1986-01-10
K854880 RADIATION BEAM DATA ACQUISTIOIN SYSTEMS Computerized Medical Systems, Inc. KPQ Class II 1986-01-10
K855219 KODAK RP X-OMAT PROCESSOR MODEL M6B Eastman Kodak Company IXW Class II 1986-01-10
K854486 TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE Absolute X-Ray Corp. IXR Class II 1986-01-10
K855213 PET-SCOPE II IMAGE INTENSIFIER Philips Medical Systems (Cleveland), Inc. JAA Class II 1986-01-10
K855043 3M DRY SILVER IMAGER 3M Company LMC Class II 1986-01-10
K852947 ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M Advanced Technology Laboratories, Inc. ITX Class II 1986-01-06
K854510 MINXRAY 500M MAMMOGRAPHIC SYSTEM Minxray, Inc. IZH Class II 1986-01-01
K853482 ACE COMPUTER SYSTEM Cardiac Medical Systems Corp. IYX Class I 1986-01-01
K854219 KODAK M35 X-OMAT PROCESSOR Eastman Kodak Company IXW Class II 1986-01-01
K851972 DIASONICS ADA400 ADVANCED DIGITAL ARRAY Diasonics, Inc. IYO Class II 1985-12-31
K853217 QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES Quantum Medical Systems, Inc. IYO Class II 1985-12-30
K854135 HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A Hewlett-Packard Co. IYO Class II 1985-12-23
K853249 RT3600(115V) RT3600(220/240V) General Electric Co. ITX Class II 1985-12-09
K853964 COMPUTERIZED RADIATION TREATMENT PLANNING SYS Computerized Medical Systems, Inc. LHN Class II 1985-12-05
K852090 SONOLAYER-L, SAL-77A Toshiba Medical Systems ITX Class II 1985-12-02
K852159 NEW OPTIONAL PROBES FOR SSA-90A Toshiba Medical Systems ITX Class II 1985-12-02
K852908 EDEC 2000 Electromed Intl., Ltd. IZO Class I 1985-11-29
K853755 ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410 Victoreen, Inc. ITX Class II 1985-11-26
K851149 KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 Keymed, Inc. JAF Class II 1985-11-26
K853470 JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 Toshiba Medical Systems IYX Class I 1985-11-19
K853852 MULTISCAN 7 Multiscan, Inc. ITX Class II 1985-11-19
K854340 TECHNICARE 720 HPS CT SCANNER Technicare Corp. JAK Class II 1985-11-15
K853330 BOOMERANG ABSORPTION COMENSATION FILTER Entreprises Octostop, Inc. KPR Class II 1985-11-15
K852284 DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA Digirad Corp. LLZ Class II 1985-11-14
K853311 LINEAR ARRAY PROBE PLB-310M FOR SAL-32B Toshiba Medical Systems IYO Class II 1985-11-13
K853444 TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS Toshiba Medical Systems JAK Class II 1985-11-08
K853570 MEDIPART DRIERITE MP-1002 Medipart Jerry Alexander IYT Class II 1985-11-07
K853579 MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133 Medipart Jerry Alexander IYT Class II 1985-11-07
K853576 MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M Medipart Jerry Alexander IYT Class II 1985-11-07
K853395 RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 Raytheon Medical Systems IZH Class II 1985-11-01
K853044 STERICOVER Sterimed, Inc. IZI Class II 1985-11-01
K851446 UNIVERSAL SERVICE MODULE Diasonics, Inc. IYO Class II 1985-10-31
K852362 UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52 Johnson & Johnson Professionals, Inc. IYO Class II 1985-10-31
K850834 SDL-32 ELECTRONIC LINEAR SCANNER Shimadzu Corp. IYO Class II 1985-10-31
K853116 PAXIAL Biophysic Medical, Inc. IYO Class II 1985-10-31

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