meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
33
Latest Decision
1991-05-20

Clearances · page 126 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K905789 FRANKLIN 9000 WALL STAND Mallinckrodt Group, Inc. KPX Class II 1991-05-20
K911437 KODAK EKTASCAN CABLE EXTENSION Eastman Kodak Company LMC Class II 1991-05-17
K910048 ECAT SCANNER Cti Pet Systems, Inc. KPS Class II 1991-05-17
K910859 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM Siemens Medical Solutions USA, Inc. JAK Class II 1991-05-17
K905691 QDR-1000 AND WITH X-RAY BONE DENSITOMETER Hologic, Inc. KGI Class II 1991-05-15
K904853 MODEL STT-100 Sonocare, Inc. IYO Class II 1991-05-15
K905653 ADVANTX AFM ANGIO SYSTEM S1808 GE Medical Systems IZI Class II 1991-05-15
K910802 POWER SCAN 1000 Webb Research, Inc. LNH Class II 1991-05-09
K911275 POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM Positron KPS Class II 1991-05-09
K911387 CT SYTEC 4000 GE Medical Systems JAK Class II 1991-05-09
K911775 OMNICATH IMPLANTED CATHETER AND DEPOT Omnitron Intl., Inc. KXK Class II 1991-05-08
K901932 VARIAN ELECTRONIC PORTAL IMAGING SYSTEM Varian Assoc., Inc. IYE Class II 1991-05-03
K910971 Z XT RADIATION THERAPY TREATMENT TABLE Siemens Medical Laboratories, Inc. JAI Class II 1991-05-03
K911082 REAL TIME X-RAY IMAGING SYSTEM Siemens Medical Solutions USA, Inc. LMA Class II 1991-05-01
K911309 UST-974-5 CONVEX TRANSDUCER Ge Medical Systems Information Technologies ITX Class II 1991-04-29
K900880 OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12 Olympus Corp. ITX Class II 1991-04-29
K901804 NORLAND XR26 WHOLE BODY OPTION Norland Corp. KGI Class II 1991-04-29
K904392 MULTILAB 2000 Unetixs, Inc. JAF Class II 1991-04-29
K910437 FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501 Fujifilm Medical System U.S.A., Inc. LLZ Class II 1991-04-24
K904599 D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM Digital Design, Inc. JWM Class II 1991-04-23
K911405 KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T Eastman Kodak Company LMD Class I 1991-04-23
K910817 GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR General Electric Co. LNH Class II 1991-04-23
K911346 SOPHYCAMERA DSX BODYTRAK Sopha Medical Systems, Inc. IYX Class I 1991-04-18
K904953 PLANMED SOPHIE Planmeca USA, Inc. IZH Class II 1991-04-18
K910862 VARIOUS TEMPLATE APPLICATORS Best Industries IWJ Class I 1991-04-18
K896151 EMISSION TOMOGRAPHY CAROUSEL Atf Consolidated KPS Class II 1991-04-16
K910384 VIDEO ANNOTATOR MODEL PK2310 Perkins Mfg. Co. JAA Class II 1991-04-16
K911339 SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K Shimadzu Medical Systems IZO Class I 1991-04-16
K905132 SHIMADZU IMAGE PROCESSOR DFS-500 Shimadzu Medical Systems LLZ Class II 1991-04-16
K910268 TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T Hitachi Medical Corp. ITX Class II 1991-04-15
K905634 SMT-50X Shimadzu Medical Systems LNH Class II 1991-04-10
K910020 CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS Capintec Instruments, Inc. IZO Class I 1991-04-08
K910092 3M LASER IMAGER XL 3M Medical Products Group LMC Class II 1991-04-08
K910269 10 ADJUSTABLE BELT COIL Resonex, Inc. LNH Class II 1991-04-08
K911267 RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004 Tri W-G, Inc. IXR Class II 1991-04-03
K910354 DU PONT IDENTIFICATION CAMERA Dupont Medical Products JAC Class I 1991-03-29
K904459 C544 TRANSDUCER Acuson Corp. ITX Class II 1991-03-29
K910308 X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 Inmark Corp. ITY Class I 1991-03-27
K904901 L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC Parexel Intl. Corp. ITX Class II 1991-03-26
K904902 SMA 26 TRANSDUCER Parexel Intl. Corp. ITX Class II 1991-03-26
K903493 NAMIC CONTRAST SAVINGS DELIVERY SYSTEM North American Instrument Corp. IZI Class II 1991-03-26
K910220 MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL Toshiba America Mri, Inc. LNH Class II 1991-03-25
K905412 ES/ULTRA DISPLAY AND PROCESSING STATION Toshiba America Medical Systems, In.C IYX Class I 1991-03-25
K910498 MAGNETOM 42 SP AND 63 SP Siemens Medical Solutions USA, Inc. LNH Class II 1991-03-25
K905801 CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO Cemax, Inc. LLZ Class II 1991-03-22
K904019 QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM Quantum Medical Systems, Inc. IYO Class II 1991-03-22
K904017 SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES Siemens Ultrasound, Inc. IYN Class II 1991-03-21
K910513 MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER Medical Advances, Inc. LNH Class II 1991-03-19
K910514 MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER Medical Advances, Inc. LNH Class II 1991-03-19
K905796 DOSE CALIBRATOR Capintec Instruments, Inc. KPT Class II 1991-03-18
K910669 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU Siemens Ultrasound, Inc. ITX Class II 1991-03-15
K910529 7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS Siemens Ultrasound, Inc. ITX Class II 1991-03-15
K910375 HELICAL SCAN Toshiba America Medical Systems, In.C JAK Class II 1991-03-15
K905607 KODAK X-OMAT MULTILOADER 300 Eastman Kodak Company IXW Class II 1991-03-12
K905603 PHILIPS GYROVIEW-HR IMAGING WORKSTATION Philips Medical Systems, Inc. LNH Class II 1991-03-08
K905512 ANTERIOR NECK CONTOUR COIL Magnetic Research, Inc. LNH Class II 1991-03-07
K904878 SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER. Hpi, Inc. IWP Class I 1991-03-07
K905748 MAMEX DC AMI SL12/MG15 Soredex, Inc. IZH Class II 1991-03-07
K910820 VPW 2877E6 X-RAY POWER SUPPLY Varian Canada, Inc. IZO Class I 1991-03-07
K910842 DI2000/HS-45-150 X-RAY TUBE INSERT Comet Ltd. C/O Radiology Resources, Inc. ITY Class I 1991-03-06
K910276 X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 Inmark Corp. ITY Class I 1991-03-06
K905695 MICRO-X 80HF Fischer Imaging Corp. IZO Class I 1991-03-06
K903561 QUICK-CLIP NEEDLE GUIDE Acuson Corp. ITX Class II 1991-03-05
K904359 ESI-3000 ULTRASOUND SYSTEM Elscint, Inc. IYN Class II 1991-03-05
K902347 COMPACT LASER IMAGER, MODEL CLI-100 Lumisys, Inc. LMC Class II 1991-03-04
K905535 ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER Ge Medical Systems Information Technologies ITX Class II 1991-02-28
K904364 VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C Varian Assoc., Inc. IYE Class II 1991-02-27
K905799 HFQ SERIES CONTROLS AND GENERATORS Bennett X-Ray Corp. IZO Class I 1991-02-26
K903603 ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) Advanced Technology Laboratories, Inc. IYO Class II 1991-02-26
K905832 MRP -5000(1): VERSION 2.0 SOFTWARE Summit World Trade Corp. LNH Class II 1991-02-25
K905833 MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY Summit World Trade Corp. LNH Class II 1991-02-25
K905294 EUB-315 Hitachi Medical Corp. of America IYO Class II 1991-02-25
K910115 PHILIPS BV-29 IMAGING SYSTEM Philips Medical Systems, Inc. OXO Class II 1991-02-20
K905834 MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY Summit World Trade Corp. LNH Class II 1991-02-19
K905835 MRP-7000: SUPPLEMENTAL R/F COILS Summit World Trade Corp. LNH Class II 1991-02-19
K904169 VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY Varian Canada, Inc. IZO Class I 1991-02-19
K902986 G.E. DXD 325/350/350II/DXD 525/525II GENERATORS Electromek Diagnostic Systems, Inc. IZO Class I 1991-02-13
K902728 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) Ausonics Pty , Ltd. ITX Class II 1991-02-13
K905855 VPW2877E7 X RAY POWER SUPPLY Varian Canada, Inc. IZO Class I 1991-02-13
K905252 ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM Ge Medical Systems Information Technologies ITX Class II 1991-02-12
K905007 STANDARD BREAST BOARDS; DELUXE BREAST BOARD Bionix Development Corp. IYE Class II 1991-02-12
K905366 MAGNETOM SP/AS (ACTIVELY SHIELDED) Siemens Medical Solutions USA, Inc. LNH Class II 1991-02-11
K903469 GAMMA 600 NUCLEAR MEDICINE COMPUTER Strichman Medical Equipment, Inc. IYX Class I 1991-02-04
K905278 STS(TM) FLUOROSCOPIC IMAGING MODULE Medstone Intl., Inc. JAA Class II 1991-02-04
K903941 SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400 Shimadzu Medical Systems IZI Class II 1991-02-04
K905615 MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL Siemens Medical Solutions USA, Inc. LNH Class II 1991-02-01
K905858 CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION Medical Advances, Inc. LNH Class II 1991-02-01
K905391 UST-969-5 CONVEX TRANSDUCER Ge Medical Systems Information Technologies ITX Class II 1991-01-31
K904124 PHILIPS MULTILEAF COLLIMATOR (MLC) Philips Medical Systems, Inc. IXI Class II 1991-01-30
K905827 FULL VIEW OMEGA TABLE Med-Tron Products, Inc. IYX Class I 1991-01-28
K905111 DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES Eigen JAA Class II 1991-01-25
K905259 VISTA HPQ SYSTEM Philips Medical Systems (Cleveland), Inc. LNH Class II 1991-01-24
K904587 DENSICOMP 250 L. Keroack Co. KPW Class II 1991-01-24
K896100 EUB-565 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America IYO Class II 1991-01-24
K905265 620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB Tri W-G, Inc. IXR Class II 1991-01-23
K903808 AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT Advanced Med/Surg, Inc. IZG Class II 1991-01-22
K905501 ELITE 5000 Fischer Imaging Corp. IXR Class II 1991-01-18
K904971 CT HILIGHT ADVANTAGE II GE Medical Systems JAK Class II 1991-01-14
K905199 PACSNET RESEARCH TOOLKIT Siemens Gammasonics, Inc. LMD Class I 1991-01-14
K904692 DB 3000 A-SCAN SYSTEM Ocuserv Instruments, Inc. IYO Class II 1991-01-14

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