meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
34
Latest Decision
1987-07-10

Clearances · page 136 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K864807 TEKNAR PROSCAN(TM) Teknar, Inc. IYO Class II 1987-07-10
K872468 JOVI MYELOGRAPHY HARNESS Jovi, Inc. KPR Class II 1987-07-01
K870821 POLYTRON MODELS 1001, 1002 AND 1004 Siemens Medical Solutions USA, Inc. LLZ Class II 1987-07-01
K871227 LES RAD FILTER M. D. Products ITY Class I 1987-06-29
K871959 FRANTZ IMAGING COMPACT CAMERA Frantz Imaging, Inc. LMC Class II 1987-06-22
K871957 SPACEMISER 8-10 FILM RECORDER Frantz Imaging, Inc. LMC Class II 1987-06-22
K871743 VIDEO PLUS MODELS VP500, VP500A AND VP1000 Camtronics, Ltd. JAA Class II 1987-06-22
K872061 LP LATERAL FLUORO POSITIONER (B5077A) General Electric Co. JAA Class II 1987-06-22
K871958 SPACEMISER 8-17 FILM RECORDER Frantz Imaging, Inc. LMC Class II 1987-06-22
K871827 OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER General Electric Co. KXJ Class II 1987-06-19
K872245 PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM General Electric Co. IXC Class I 1987-06-19
K870400 SCX INFORMATION MANAGEMENT SYSTEM General Electric Co. KPR Class II 1987-06-18
K872127 D-SCOPE II AND D-SCOPE IIC Medx, Inc. IYX Class I 1987-06-18
K871778 DIGISPOT IMAGER Siemens Gammasonics, Inc. LMC Class II 1987-05-29
K871911 THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION F. Spoon Co. JAA Class II 1987-05-29
K871592 RF-1 CIRCUIT Diagnostic Imaging Specialists Corp. IZH Class II 1987-05-22
K870707 PENTAMAX 1 MODEL B TABLE SYSTEM Spectrum X-Ray Corp. IXR Class II 1987-05-14
K871116 X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R X-Cel X-Ray Corp. IYH Class II 1987-05-14
K870221 T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) Kermath Mfg. Corp. KPQ Class II 1987-05-12
K871214 GRATICULE Mick Radio-Nuclear Instruments, Inc. IYE Class II 1987-05-08
K870513 CSI/3D Columbia Scientific, Inc. JAK Class II 1987-05-08
K871502 PERSONNEL PROTECTIVE SHIELD Cis-Us, Inc. KPY Class I 1987-05-08
K871127 DTV-4112 FLUOROSCOPIC TELEVISION CAMERA Adac Laboratories JAA Class II 1987-05-01
K870869 DTV-411OP Adac Laboratories JAA Class II 1987-05-01
K860777 MATRIX LD & LD/LASER DIGITIZER Matrix Instruments LMA Class II 1987-04-22
K870748 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE Philips Ultrasound, Inc. ITX Class II 1987-04-10
K871215 DISPOSABLE SHADOW TRAY INSERTS Mick Radio-Nuclear Instruments, Inc. IWB Class II 1987-04-06
K870525 PHILIPS MODEL SL75-10 LINEAR ACCELERATOR Industrial Accelerator Co. IYE Class II 1987-04-01
K871145 EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR Electromed Intl., Ltd. IZO Class I 1987-03-31
K871175 JUMBO DIGITAL GAMMACAMERA, GCA-901A Toshiba Medical Systems IYX Class I 1987-03-31
K871119 CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D Canon USA, Inc. JAA Class II 1987-03-31
K870038 TRT TRANS-RECTAL TRANSDUCER Advanced Technology Laboratories, Inc. ITX Class II 1987-03-30
K870856 COSMOS Pausch Corp. IYB Class I 1987-03-30
K870300 BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 Belmont Equipment Corp. KPR Class II 1987-03-25
K863708 7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12 Siemens Medical Solutions USA, Inc. ITX Class II 1987-03-23
K870851 EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR Electromed Intl., Ltd. IZO Class I 1987-03-20
K864910 MEVACHECK Magus Microcontrollers, Inc. IYE Class II 1987-03-16
K870818 BODYSCAN Siemens Gammasonics, Inc. IYX Class I 1987-03-16
K870964 ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER Elscint, Inc. IYO Class II 1987-03-13
K864758 DIASONICS SPA 5.O 27MM PROBE Diasonics, Inc. ITX Class II 1987-03-10
K864812 DIASONICS SPA 3.5 MHZ, 30MM PROBE Diasonics, Inc. ITX Class II 1987-03-10
K863618 BONE MINERAL DENSITOMETRY OPTION B7918AA General Electric Co. KGI Class II 1987-03-09
K863853 EAZY COVERS Superior Medical Products JAA Class II 1987-03-06
K864222 SERIES 620 RECTAL PROBE COVER General Electric Co. ITX Class II 1987-03-04
K865084 AMICI XENON REBREATHING SYSTEM* Amici, Inc. IYT Class II 1987-03-03
K861233 DUAL PHOTON BONE DENSITOMETER Medical and Scientific Enterprises, Inc. KGI Class II 1987-03-03
K862686 KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM Kontron Instruments, Inc. ITX Class II 1987-02-27
K863364 DIAGNOSTIC ULTRASONIC TRANSDUCER Toshiba Medical Systems ITX Class II 1987-02-27
K870703 SKAN D-SCOPE Medx, Inc. IYX Class I 1987-02-26
K870565 KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L Eastman Kodak Company JAC Class I 1987-02-26
K862414 FUJI CR IMAGING PLATE Parexel Intl. Corp. EAM Class I 1987-02-26
K864854 VIEW(TM) IMAGE PROCESSING AND VIEWING STATION Virtual Imaging LLZ Class II 1987-02-26
K870701 KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL Eastman Kodak Company JAC Class I 1987-02-26
K863577 DOPPLER UNIT, SDS-100A Toshiba Medical Systems IYN Class II 1987-02-25
K870563 X-RAY APRON X-Tech, Ltd. EAJ Class I 1987-02-19
K855247 INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER Codman & Shurtleff, Inc. ITX Class II 1987-02-19
K860581 QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM Quantum Medical Systems, Inc. IYO Class II 1987-02-13
K864519 PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) Parexel Intl. Corp. LLZ Class II 1987-02-13
K870429 EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186) The Mason Clinic JAA Class II 1987-02-11
K864739 KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM P1 Eastman Kodak Company LLZ Class II 1987-02-11
K864927 KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10 Eastman Kodak Company LLZ Class II 1987-02-11
K863700 RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE General Electric Co. ITX Class II 1987-02-10
K864749 TELAMAT Comet Ltd. C/O Radiology Resources, Inc. JAA Class II 1987-02-10
K861515 OSTEOPAK BMD (BONE MINERAL DENSITOMETER) Siemens Gammasonics, Inc. KGI Class II 1987-02-02
K864958 ALPHA II DIAGNOSTIC X-RAY Ausonics Pty , Ltd. IZH Class II 1987-01-30
K864837 MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM Oec-Diasonics, Inc. JAA Class II 1987-01-30
K864135 280SL IMAGING SYSTEM SMALL PARTS PROBES Ge Medical Systems Information Technologies ITX Class II 1987-01-27
K864136 260SL IMAGING SYSTEM SMALL PARTS PROBES Ge Medical Systems Information Technologies ITX Class II 1987-01-27
K870071 TOSHIBA, SMIT ROENTGEN North American Imaging, Inc. ITY Class I 1987-01-21
K870103 LEAD APRON CADDY Orthopedic Systems, Inc. EAJ Class I 1987-01-21
K863309 REFURBISH DIAGNOSTIC X-RAY EQUIPMENT Chemarts and Assoc., Inc. KPR Class II 1987-01-16
K863132 DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE General Electric Co. LLZ Class II 1987-01-14
K862294 THE IMAGE/R Quantum Diagnostics, Ltd. LLZ Class II 1987-01-14
K865100 TISSUE-EQUIVALENT BREAST SIMULATOR Computerized Imaging Reference Systems, Inc. IXF Class I 1987-01-12
K870048 ADDITIONAL MODEL TO CANON UNIVERSAL STAND Canon USA, Inc. KPX Class II 1987-01-12
K863947 SONOLAYER-L, SAL-77B Toshiba Medical Systems IYO Class II 1987-01-09
K864336 PACHYMETER SYSTEM V CooperVision, Inc. IYO Class II 1987-01-09
K861514 VNA OPTICAL CORRELATOR Vna Systems, Inc. LLZ Class II 1987-01-07
K864527 DUOCEPH Gary E. Hall, Dds IWY Class I 1987-01-07
K863936 DUFFY BOLUS INJECTOR Viox Corp. IWR Class I 1987-01-06
K863705 COMPUTER CONTROLLED EXTENSION (CCX) Varian Assoc., Inc. IYE Class II 1987-01-06
K862867 EUB-310 ULTRASONIC SCANNER Hitachi Medical Corp. of America IYO Class II 1987-01-05
K862211 ULTRASOUND TRANSDUCER ASSEMBLY Johnson & Johnson Professionals, Inc. ITX Class II 1987-01-02
K863780 ADA-1000 (ADVANCED DIGITAL ARRAY) Diasonics, Inc. IYO Class II 1986-12-29
K864584 FLUOROVISION CONTRAST ENHANCER Digivision, Inc. JAA Class II 1986-12-29
K864263 NEOPROBE PORTABLE RADIOISOTOPE DETECTOR Neoprobe Corp. IZD Class I 1986-12-29
K860757 OPHTHASONIC A-SCAN Teknar, Inc. IYO Class II 1986-12-18
K864398 STORZ SOLID & ANGLED SOLID CONTACT PROBES Storz Instrument Co. IYO Class II 1986-12-18
K861692 FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM Fischer Imaging Corp. IZH Class II 1986-12-15
K864339 PORTA RAY MODEL 325 Porta Ray, Inc. IZO Class I 1986-12-15
K863576 EUB-400 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America IYO Class II 1986-12-12
K862127 DYMAX PERSONAL SCANNER Dymax Corp IYO Class II 1986-12-11
K863935 TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY Toshiba Medical Systems JAK Class II 1986-12-02
K862158 AVP TELEIMAGING SYSTEM Advanced Video Products, Inc. LMD Class I 1986-11-28
K862165 ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340 Hitachi Medical Corp. of America IYO Class II 1986-11-28
K864210 MICROSELECTRON-HDR (HIGH DOSE RATE) Nucletron-Oldelft Corp. JAQ Class II 1986-11-26
K862744 TELERADIOGRAPHY SYSTEM E.I. Dupont DE Nemours & Co., Inc. LMD Class I 1986-11-26
K862844 7.5 MHZ LINEAR PROBE, CAT. NO. H4221H General Electric Co. ITX Class II 1986-11-25
K863338 7.5 MHZ LINEAR SMALL PARTS PROBE Siemens Medical Solutions USA, Inc. IYO Class II 1986-11-24
K862309 PC-DISPLAY Hi-Tech Medical Systems, Inc. LLZ Class II 1986-11-12

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