meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
35
Latest Decision
1981-03-02

Clearances · page 144 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K810190 OPTI 110/12/50HSG Siemens Corp. ITY Class I 1981-03-02
K810191 SIRCAM 103 Siemens Corp. IZJ Class II 1981-02-26
K810194 WALL CASSETTE HOLDER - TRAC44 Philips Medical Systems (Cleveland), Inc. IXY Class I 1981-02-25
K810183 PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION Philips Medical Systems (Cleveland), Inc. IZI Class II 1981-02-25
K802434 VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH Varian Assoc., Inc. IYO Class II 1981-02-19
K810118 LS1000 ELECTRONIC FOCUS Philips Medical Systems (Cleveland), Inc. IYN Class II 1981-02-19
K810254 1.5` FOCAL SPOT RESOLUTION PATTERN Machlett Laboratories, Inc. IXF Class I 1981-02-19
K810072 105MM ROLL FILM FLUOROGR. CAMERA, #105 Scientex Corp. IZJ Class II 1981-02-12
K810095 MOTI APRON Moti Enterprises, Inc. KPY Class I 1981-02-12
K810140 DUAL-PHOTON TOTAL BODY BONE MINERAL ANA Lunar Radiation Corp. KGI Class II 1981-02-12
K810159 BONE MINERAL ANALYZER CONTROLLER Lunar Radiation Corp. KGI Class II 1981-02-12
K802140 LEKSELL STEREOTACTIC SYSTEM Downs Surgical , Ltd. IWY Class I 1981-02-05
K810006 TOMOMATIC 64 Medimatic IZD Class I 1981-02-02
K810051 SELECTRON REMOTE ISOTOPE Victoreen, Inc. JAQ Class II 1981-02-02
K803157 AUTO-MATE CAMERA Aptek , Ltd. IYO Class II 1981-02-02
K803130 MULTIX U. BUCKY TABLE X-RAY UNIT Siemens Corp. KPR Class II 1981-01-28
K803162 X-RAY STAND & OPERATING CHAIR Downs Surgical , Ltd. IYB Class I 1981-01-28
K803246 ULTRASONIC STETHOSCOPE Sonicaid, Inc. IYN Class II 1981-01-28
K803181 SCANNER, COMPUTERIZED TOMOGRAPHIC General Electric Co. JAK Class II 1981-01-28
K802979 DIASONICS SMALL PARTS SCANNER Diasonics, Inc. IYN Class II 1981-01-22
K803103 TECHNY REX 3000 MOBILE X-RAY UNIT Tecnomed, Inc. IZL Class II 1981-01-22
K803124 SIDOS U. Siemens Corp. KPQ Class II 1981-01-22
K803120 TILTING IMAGING TABLE #846T Quinton, Inc. KXJ Class II 1981-01-22
K803032 PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. Pfizer Medical Systems, Inc. KPQ Class II 1981-01-22
K802438 MARK V DUPLEX ULTRASONIC SCAN SYS. Advanced Technology Laboratories, Inc. ITX Class II 1981-01-21
K802437 MARK III ULTRASONIC SCANNING SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1981-01-15
K802801 GE RT/PLAN MAGNETIC TAPE DRIVE OPTION General Electric Co. KPS Class II 1981-01-15
K802905 MULTI-IMAGE CAMERA-#627 TLC Dunn Systems, Inc. IYO Class II 1981-01-15
K802941 CINESCOPE III RADIOGRAPHIC GENERATOR Controtec, Inc. IZO Class I 1981-01-09
K802953 DIGITAL FLUOROGRAPHIC X-RAY SYSTEM General Electric Co. JAA Class II 1981-01-09
K802996 VECTOR-100 X-RAY GENERATOR Philips Medical Systems (Cleveland), Inc. IZO Class I 1981-01-09
K802888 RAYTHEON MEDICAL IMAGING Machlett Laboratories, Inc. IXL Class II 1981-01-09
K802809 ELECTRON ARC THERAPY Varian Assoc., Inc. IYE Class II 1981-01-07
K802695 DATASON RTL II General Electric Co. IYO Class II 1981-01-07
K802808 6MV PORT FILM CAPABILITY OPTION Varian Assoc., Inc. IYE Class II 1981-01-07
K802759 SIEMENS PHO/SONIC ALPHA 1000 Siemens Gammasonics, Inc. IYO Class II 1981-01-07
K802708 SYSTEM, ECHO, PULSED ULTRASONIC DIAG. General Electric Co. IYO Class II 1981-01-07
K802180 WISCONSIN DUAL-PHOTON BONE ANALYZER Lunar Radiation Corp. KGI Class II 1980-12-31
K802181 WISCONSIN BONE MINERAL ANALYZER Lunar Radiation Corp. KGI Class II 1980-12-31
K802531 PFIZONIC 200 ULTRASOUND SCANNER Pfizer Medical Systems, Inc. IYO Class II 1980-12-18
K802532 PFIZONIC 300 ULTRASOUND SCANNER Pfizer Medical Systems, Inc. IYO Class II 1980-12-18
K801748 3M I-125 SEEDS IN ABSORBABLE CARRIER 3M Company KXK Class II 1980-12-18
K802528 PFIZONIC 150 ULTRASOUND SCANNER Pfizer Medical Systems, Inc. IYO Class II 1980-12-18
K802530 PFIZONIC 250 ULTRASOUND SCANNER Pfizer Medical Systems, Inc. IYO Class II 1980-12-18
K801954 HP MODEL 77020A ULTRASOUND SYSTEM Hewlett-Packard Co. IYO Class II 1980-12-16
K802704 SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR. Cgr Medical Corp. IYO Class II 1980-12-11
K802341 DIOSCAN Sonometrics Systems, Inc. IYO Class II 1980-12-10
K802549 GENERATOR, HIGH VOLT, X-RAY, MPX 100 General Electric Co. IZO Class I 1980-12-02
K802550 GENERATOR, HIGH VOLT, X-RAY, MPX 125 General Electric Co. IZO Class I 1980-12-02
K802548 GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 General Electric Co. IZO Class I 1980-12-02
K802551 GENERATOR, HIGH VOLT, X-RAY, MPX100/125 General Electric Co. IZO Class I 1980-12-02
K802254 GENERAL ULTRASOUND EXAM. TABLE Engineering Dynamics Corp. IYN Class II 1980-11-26
K802475 A2 IMAGE PROCESSING SYSTEM Medtronic Vascular IYX Class I 1980-11-26
K801986 DATASON DB SYSTEM General Electric Co. IYO Class II 1980-11-12
K802171 KODAK ORTHO L FILM Eastman Kodak Company IWZ Class I 1980-10-31
K802263 MINIVISOR TERMINAL Organon Teknika Corp. IYO Class II 1980-10-31
K802377 MOTI PROTECTIVE X-RAY MASK Moti Enterprises, Inc. KPY Class I 1980-10-31
K801971 IN-LINE SCAN HEAD MODIFICATION MARK III Advanced Technology Laboratories, Inc. ITX Class II 1980-10-23
K801972 TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX Advanced Technology Laboratories, Inc. IYN Class II 1980-10-23
K802150 DIGITAL RADIOGRAPHY SYSTEM Adac Laboratories JAA Class II 1980-10-23
K802216 VIEW-LITE, MODEL-DL Med-Western Electronics, Inc. IXC Class I 1980-10-23
K802217 VIEW-LITE, MODEL-SL Med-Western Electronics, Inc. IXC Class I 1980-10-23
K802200 VERTIX 3D-U Siemens Corp. KPR Class II 1980-10-23
K802047 AMX-III General Electric Co. IZL Class II 1980-10-23
K801973 IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA Advanced Technology Laboratories, Inc. ITX Class II 1980-10-23
K802045 G.E. SCAN CAPABILITY CAT.#B7815F General Electric Co. JAK Class II 1980-10-23
K802132 105MM SPOT FILM CAMERA Instrumentation Camera, Inc. IZJ Class II 1980-10-23
K802206 OMNI SCANNER CT 6000 Omnimedical JAK Class II 1980-10-23
K801983 SCOTT NEEDLE & SCOTT MICK IMPLANTER Mick Radio-Nuclear Instruments, Inc. IWJ Class I 1980-10-23
K802215 VIEW-LITE, MODEL-S Med-Western Electronics, Inc. IXC Class I 1980-10-23
K802146 AQUASONIC 100 ULTRASOUND TRANS. GEL, Parker Laboratories, Inc. IYO Class II 1980-10-10
K801950 BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO B C Medical , Ltd. KPX Class II 1980-10-03
K801844 SONIA-SO NOGRAPH-NUMERICAL ANALYSIS Cgr Medical Corp. IYO Class II 1980-10-03
K801808 BR 2002 X-RAY GENERATOR SYSTEM Valmet Indus. Mach. & Prod., Inc. IZO Class I 1980-09-26
K801656 EDP 1200 SECTOR SCANNER OPTION Unirad Corp. IYN Class II 1980-09-26
K801948 DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM Technicare Corp. JAA Class II 1980-09-26
K801655 AUTO SECTOR SCANNER Unirad Corp. IYN Class II 1980-09-26
K801917 STAR General Electric Co. JWM Class II 1980-09-16
K801454 DATASON RTL General Electric Co. IYO Class II 1980-09-16
K801653 MAXI CAMERA 37 General Electric Co. IYX Class I 1980-08-20
K801598 MARK V DUPLEX ULTRASONIC SCANNING SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1980-08-20
K801512 DOPPLER ULTRASONIC STETHOSCOPE Mountain Medical Equipment, Inc. IYN Class II 1980-08-20
K801654 MAXI CAMERA 61 General Electric Co. IYX Class I 1980-08-20
K801541 WALL MOUNTED LASER POSITIONING DEVICE Advantage Medical Systems, Inc. IWE Class I 1980-08-20
K801446 PFIZER PZ-CT SCANNER Pfizer Medical Systems, Inc. JAK Class II 1980-07-28
K801408 CINESCOPE III Philips Medical Systems (Cleveland), Inc. IZO Class I 1980-07-28
K801407 SYNERVIEW MODEL 6545 Philips Medical Systems (Cleveland), Inc. JAK Class II 1980-07-28
K801406 MARK III ULTRASONIC SCANNING SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1980-07-28
K801368 A2 IMAGE PROCESSING SYSTEM Medtronic Vascular IYX Class I 1980-07-21
K801320 SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 General Electric Co. JAA Class II 1980-07-21
K801168 COLLIMAX X-RAY COLLIMATOR # R-182 Ito X-Ray Corp. IZX Class II 1980-07-08
K800768 VASCULAB BI-DIRECTIONAL DOPPLER, #D10 Medasonics, Inc. JAF Class II 1980-07-08
K801209 KODAK MEDICAL X-RAY DEVELOPER & REPLEN. Eastman Kodak Company IXW Class II 1980-06-26
K801166 PET-SCOPE II MODEL DIS-1611 Diagnostic Information, Inc. JAA Class II 1980-06-26
K801060 HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE Smithkline Diagnostics, Inc. IYO Class II 1980-06-04
K801056 EDP 1200 ULTRASONIC B-SCANNER Technicare Corp. IYO Class II 1980-06-04
K800901 KODAK EKTASPEED DENTAL X-RAY FILM Eastman Kodak Company IWZ Class I 1980-05-20
K800790 TENNIS RACKET-TABLE INSERT PANEL Radiation Products Design, Inc. IYE Class II 1980-05-14
K800791 MYLAR WINDOW-TABLE INSERT PANEL Radiation Products Design, Inc. IYE Class II 1980-05-14
K800759 ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER Radiation Products Design, Inc. IYE Class II 1980-05-14

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