meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
34
Latest Decision
1991-01-14

Clearances · page 127 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K904684 AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION Amici, Inc. IYT Class II 1991-01-14
K903805 AMICI XENON ADMINISTRATION SET Amici, Inc. IYT Class II 1991-01-14
K905095 MODEL 3100-21: QUADRATURE SPINE COIL Medical Advances, Inc. LNH Class II 1991-01-11
K904665 MODEL IW17.5A INTRA OPERATIVE TRANSDUCER Kretztechnik AG ITX Class II 1991-01-11
K903315 ICON Siemens Gammasonics, Inc. JWM Class II 1991-01-09
K905104 MODEL 3100-64: QUADRATURE SPINE COIL Medical Advances, Inc. LNH Class II 1991-01-08
K904174 STARCAM 4000 General Electric Co. IYX Class I 1991-01-04
K904127 A2J TELEMETER A2j, Inc. IWE Class I 1991-01-04
K904933 VARIOUS AFTERLOADING APPLICATORS Best Assoc. Corp. IWJ Class I 1991-01-04
K905566 KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS Eastman Kodak Company LMC Class II 1991-01-03
K904114 ANATECH X-RAY GENERATOR Continental X-Ray Corp. IZO Class I 1991-01-03
K905070 VISTAR Philips Medical Systems (Cleveland), Inc. LNH Class II 1991-01-02
K902691 DOPPLER OPTION FOR PLATINUM Philips Medical Systems, Inc. IYN Class II 1991-01-02
K905222 CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0 Nuccardiac Software, Inc. LLZ Class II 1990-12-26
K902987 G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS Electromek Diagnostic Systems, Inc. IZO Class I 1990-12-26
K905442 MRT35-SP Toshiba America Mri, Inc. LNH Class II 1990-12-21
K902985 G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN Electromek Diagnostic Systems, Inc. IZO Class I 1990-12-19
K902988 G.E. MSI 850/850II/1250 THREE PHASE GENERATORS Electromek Diagnostic Systems, Inc. IZO Class I 1990-12-19
K905441 MRT 35-A (TM) Toshiba America Mri, Inc. LNH Class II 1990-12-14
K904146 NEURO VISION RADIOGRAPHIC X-RAY SYSTEM Mallinckrodt Group, Inc. KPR Class II 1990-12-13
K904145 HYDRA VISION UROLOGICAL X-RAY SYSTEM Mallinckrodt Group, Inc. KPR Class II 1990-12-13
K904144 PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM Mallinckrodt Group, Inc. IZP Class II 1990-12-13
K904147 HUGH YOUNG II UROLOGICAL X-RAY SYSTEM Mallinckrodt Group, Inc. KPR Class II 1990-12-13
K905153 REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110 Shimadzu Medical Systems IXR Class II 1990-12-11
K905152 REMOTE CONTROLLED X-RAY DIAG. RSZ-200 Shimadzu Medical Systems IXR Class II 1990-12-11
K902488 MODIFIED CASS SYSTEM Medical Instrumentation & Diagnostics Corp.(Midco) KXK Class II 1990-12-07
K900932 37-702 AND 37-703 PC RAINBOW Victoreen, Inc. IYI Class II 1990-12-05
K904980 DPX-L AND DPX-ALPHA, MODIFICATION Lunar KGI Class II 1990-12-05
K904050 MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA Philips Medical Systems (Cleveland), Inc. IYX Class I 1990-12-05
K903921 MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE Imt America, Inc. IZZ Class II 1990-12-04
K904986 PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 Perkins Mfg. Co. JAA Class II 1990-12-04
K905086 HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES Hpi, Inc. IWP Class I 1990-12-03
K904012 PHILIPS INTEGRIS I 2000 SYSTEM Philips Medical Systems, Inc. JAA Class II 1990-11-29
K904005 HUESTIS FLEXI-BOARD Huestis Machine Corp. JAD Class II 1990-11-29
K904044 TF-63SA Toshiba America Medical Systems, In.C KPW Class II 1990-11-29
K903373 CATHETERIZATION C-ARM SUPPORT MH-51C(F) Shimadzu Medical Systems IZI Class II 1990-11-29
K904043 KXO-80C/80D Toshiba America Medical Systems, In.C IZO Class I 1990-11-29
K903372 CATH MULTIDIRECT BI-PLANE RADIO SYST MH-51A/MH-31A Shimadzu Medical Systems IZI Class II 1990-11-29
K904187 ECONOMY C-ARM TABLE, MODEL # 056-005 Atomic Products Corp. IXQ Class II 1990-11-29
K903371 CATHETERIZATION C-ARM SUPPORT MH-51B(F) Shimadzu Medical Systems IZI Class II 1990-11-29
K902926 COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM Philips Medical Systems North America, Inc. ITX Class II 1990-11-26
K901654 MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE Imt America, Inc. IXR Class II 1990-11-23
K903806 ANGIOTEC IMAGE MANAGEMENT SYSTEM Andros Analyzers, Inc. LMB Class I 1990-11-23
K902959 NORLAND XR26 LATERAL SPINE OPTION Norland Corp. KGI Class II 1990-11-23
K901329 CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. IYN Class II 1990-11-23
K903326 NIDEK US-2000 Nidek, Inc. IYO Class II 1990-11-21
K903770 MRT 50A Toshiba America Mri, Inc. LNH Class II 1990-11-20
K903768 MAGNETIC RESONANCE DEVICE MRT 150A Toshiba America Mri, Inc. LNH Class II 1990-11-20
K904528 INSTRUMENTARIUM MEGA4, MODIFICATION Instrumentarium Imaging, Inc. LNH Class II 1990-11-20
K904327 ADVANCED C- SPINE COIL Toshiba America Mri, Inc. LNH Class II 1990-11-20
K904897 MODEL 400 ULTRA COMPACT VIDEO IMAGER International Imaging Electronics LMC Class II 1990-11-20
K904103 SEP 90 Elema-Schonander, Inc. IZP Class II 1990-11-20
K903318 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30 Summit World Trade Corp. LNH Class II 1990-11-20
K902428 INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS GE Medical Systems LLZ Class II 1990-11-19
K904517 MAMMOSPOT 3 AND MAMMOSPOT 8 American Mammographics, Inc. IZH Class II 1990-11-15
K903651 AMI MAMMOSPOT American Mammographics, Inc. IZH Class II 1990-11-15
K904363 MULTI FORMAT VIDEO IMAGER 600 PLUS International Imaging Electronics LMC Class II 1990-11-13
K904590 KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP Eastman Kodak Company LLZ Class II 1990-11-13
K903661 BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD Bruker Medical Imaging, Inc. LNH Class II 1990-11-13
K904182 R-800-SF Advantech ITY Class I 1990-11-13
K902982 G.E. POLARIX II C-ARM Electromek Diagnostic Systems, Inc. JAA Class II 1990-11-13
K904397 TEC 1410 Bay Shore Medical Equipment Corp. IZO Class I 1990-11-13
K904753 DIOLASE Scanditronix, Inc. IWE Class I 1990-11-09
K902214 BIOPSY NEEDLE TRANSPONDER SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1990-11-08
K903139 BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743) Siemens Medical Laboratories, Inc. IYE Class II 1990-11-07
K902981 G.E. FLUOROCON 300 IMAGING SYSTEM Electromek Diagnostic Systems, Inc. JAA Class II 1990-11-07
K903821 PSC-1 W/OTHER NUMERICAL Eigen JAA Class II 1990-11-07
K903701 XPRESS Toshiba America Medical Systems, In.C JAK Class II 1990-11-07
K902983 SIEMEN'S SIREMOBILE II C-ARM Electromek Diagnostic Systems, Inc. JAA Class II 1990-11-06
K904623 RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 Atomic Products Corp. IXQ Class II 1990-11-06
K903238 AFGA VIDEO IMAGER, VARIOUS MODELS Enhanced Imaging Technologies, Inc. LMC Class II 1990-11-02
K903763 COMPUTED TOMOGRAPHY X-RAY SYSTEM General Electric Co. JAK Class II 1990-11-02
K902791 G.E. 48-4 CEILING TUBEHANGER Electromek Diagnostic Systems, Inc. KPR Class II 1990-10-29
K903622 CT GUIDE (TM) Radi Medical Systems AB JAK Class II 1990-10-29
K902989 G.E. MONITROL 90 AND G.E. MONITROL 15 Electromek Diagnostic Systems, Inc. IXR Class II 1990-10-29
K903030 SOPHYCAMERA DSM 315 Provino IYX Class I 1990-10-29
K903755 CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED Medical Advances, Inc. LNH Class II 1990-10-26
K903754 CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED Medical Advances, Inc. LNH Class II 1990-10-26
K904540 VIDEO SYSTEM INTERFACE MODELS Perkins Mfg. Co. IZI Class II 1990-10-26
K902984 G.E. AMX 110, AMX II AND AMX 3 X-RAY UNITS Electromek Diagnostic Systems, Inc. IZL Class II 1990-10-26
K903753 CAT. #6000-21 VOLUME NECK COIL, MODIFIED Medical Advances, Inc. LNH Class II 1990-10-26
K902799 GYROSCAN S15/ACS Philips Medical Systems, Inc. LNH Class II 1990-10-23
K902980 G.E. XT CEILING TUBE SUSPENSION Electromek Diagnostic Systems, Inc. JAA Class II 1990-10-23
K900434 MM-22 MICROTRON, MM50 MICROTRON Scanditronix, Inc. IYE Class II 1990-10-23
K903988 PANORAMIC OMEGA IMAGING TABLE Med-Tron Products, Inc. IYX Class I 1990-10-23
K904447 SONY CINE VIDEO SYSTEM SME-3500 Sony Medical Electronics Co. IZI Class II 1990-10-17
K904489 EUREKA EXTENSION CYLINDERS Eureka X-Ray Tube Corp. KPW Class II 1990-10-15
K902533 PULSED SELECTRON Nucletron-Oldelft Corp. JAQ Class II 1990-10-12
K903465 IR-192 IMPLANT Rads S.L., Inc. KXK Class II 1990-10-12
K902245 SONICATH(TM) 9F, 12 MHZ Boston Scientific Corp ITX Class II 1990-10-09
K902761 AUTOMATIC CASSETTE LOADER Mallinckrodt Group, Inc. KPX Class II 1990-10-09
K902411 NIDEK US-2500 W/BIOMETRY UNIT US-2520 Nidek, Inc. IYO Class II 1990-10-09
K900155 INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER Interspec, Inc. ITX Class II 1990-10-05
K903694 AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE Amici, Inc. IYT Class II 1990-10-03
K903942 SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G Shimadzu Medical Systems IZO Class I 1990-10-03
K904238 KODAK X-MAT 270 RA PROCESSOR Eastman Kodak Company IXW Class II 1990-10-03
K903822 MODEL 4500-SMS-42; SHOULDER COIL Medical Advances, Inc. LNH Class II 1990-10-01
K903375 HICOR Siemens Gammasonics, Inc. IZI Class II 1990-10-01
K903403 CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR University of Michigan IWJ Class I 1990-10-01
K902583 JOINT MOTON IMAGER(TM) Concord Imaging, Ltd. JAA Class II 1990-09-27

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