meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
36
Latest Decision
1978-05-09

Clearances · page 147 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K780651 ULTRASONIC DIAGNOSTIC TRANSDUCER Hoffrel Instruments, Inc. ITX Class II 1978-05-09
K780491 DATA CAMERA General Electric Co. IYX Class I 1978-04-18
K780510 NUCLEAR STETHOSCOPE Bios, Inc. IYY Class I 1978-04-18
K780480 CT/T INDEPENDENT DIAGNOSTIC CENTER General Electric Co. JAK Class II 1978-04-18
K780395 IMAGER, BODY SECTION, RADIONUCLIDE Union Carbide Corp. IYW Class I 1978-03-31
K780319 ORBITOME-UG Philips Medical Systems (Cleveland), Inc. IZF Class II 1978-03-14
K780369 MODUMED MUGE Medtronic Vascular JWM Class II 1978-03-14
K780326 GE CT/T 8800 SYSTEM General Electric Co. JAK Class II 1978-03-14
K780368 MODUMED MUGX Medtronic Vascular JWM Class II 1978-03-14
K780313 HITACHI TECH-MOBLE DHC-121 Philips Medical Systems (Cleveland), Inc. IZL Class II 1978-03-14
K780155 DUAL CHANNEL PULSE HEIGHT ANALYZER Iso Graphics, Inc. IYX Class I 1978-03-02
K780165 PROCESSOR, VIDEO IMAGE VIP-550 Ohio Nuclear, Inc. IYX Class I 1978-03-02
K780200 ULTRASCOPE L&M Ultrascope Life Monitoring Sys. JAF Class II 1978-03-02
K780201 SPEAKER-AMPLIFIER & RECORDER INTERFACE L&M Ultrascope Life Monitoring Sys. JAF Class II 1978-03-02
K780248 CRONEX QC-1 PROCESSOR E.I. Dupont DE Nemours & Co., Inc. IXW Class II 1978-03-02
K780278 RADIATION THERAPY TREAT. PLAN. SYS. Pfizer Medical Systems, Inc. JAD Class II 1978-03-02
K780157 RADIATION TREATMENT PLANNING SYSTEM Capintec, Inc. JAD Class II 1978-02-13
K780115 SCANNERS, TOMOGRAPHIC, COMPUTED Ohio Nuclear, Inc. JAK Class II 1978-01-30
K772313 X-RAY CO-ORDINATOR Rinn Corp. IWY Class I 1978-01-30
K780027 ACCELERATOR, LINEAR, MED. Emi Therapy Systems, Inc. IYE Class II 1978-01-26
K780060 CAMERA, GAMMA Ackerman-Schmehl Industries, Inc. IYX Class I 1978-01-26
K771817 EMI THERAPY SIMULATOR Emi Therapy Systems, Inc. JAD Class II 1978-01-13
K770999 LITTON 300L ULTRASOUND SYSTEM Electra-Physics Laboratories, Inc. IYO Class II 1978-01-12
K772317 CT/T SYSTEM MODEL B7800A General Electric Co. JAK Class II 1978-01-11
K772305 RAD. THERAPY PLANNING SUP. SYS. Ohio Nuclear, Inc. JAK Class II 1978-01-09
K772291 DIAG. CONSOLE, INDEPENDENT Pfizer, Inc. JAK Class II 1977-12-21
K772289 SCANNER, CT, 0400 Pfizer Medical Systems, Inc. JAK Class II 1977-12-21
K772283 RX PEDESTAL TABLE General Electric Co. IZZ Class II 1977-12-15
K772198 CT SCANNER DIAGNOSTIC CONSOLE, REMOTE Varian Assoc., Inc. JAK Class II 1977-12-05
K771990 OMNIMEDICAL 400L Omnimedical Services, Inc. JAK Class II 1977-11-30
K771978 CTR 100L Emi Medical, Inc. JAK Class II 1977-11-23
K772123 TOMOGRAPHIC SYSTEM, COMPUTERIZED Philips Medical Systems (Cleveland), Inc. JAK Class II 1977-11-21
K772125 TOMOGRAPHIC SCANNER, COMPUTERIZED Emi Medical, Inc. JAK Class II 1977-11-21
K772012 VIDEO ADAPTER FOR GRAPHIC RECORDERS Honeywell, Inc. IYO Class II 1977-11-07
K771930 EMISONIC 4500 TM Emi Medical, Inc. IYO Class II 1977-10-27
K771878 IRIDIUM 192 WIRES & PINS Cis Radiopharmaceuticals, Inc. IWA Class II 1977-10-27
K771934 LINEAR ARRAY B-MODE SCANNER G.D. Searle and Co. IYO Class II 1977-10-25
K771811 EMI CTR 100 Emi Medical, Inc. JAK Class II 1977-10-19
K771857 AUTOMIXER, KODAK Eastman Kodak Company IXW Class II 1977-10-19
K771808 CLINAC 4/100 Varian Assoc., Inc. IYE Class II 1977-10-19
K771902 EMI FOUR Emi Therapy Systems, Inc. IYE Class II 1977-10-19
K771809 CLINAC 6/100 Varian Assoc., Inc. IYE Class II 1977-10-19
K771688 ECHO-OCULOMETER Storz Instrument Co. IYO Class II 1977-09-26
K771600 ULTRASOUND Toshiba Medical Systems IYO Class II 1977-09-22
K771682 MIN-R CASSETTE Eastman Kodak Company IXA Class II 1977-09-20
K771599 GAMMA CAMERAS -GXA-301 & GCA-402 Toshiba Medical Systems IYX Class I 1977-09-20
K771601 X-RAY REMOTE CONTROL TABLE Toshiba Medical Systems IZZ Class II 1977-09-20
K771689 DIAL X COLLIMATOR MODEL A&B Bennett X-Ray Corp. IZX Class II 1977-09-14
K771681 ORTHO H FILM Eastman Kodak Company IWZ Class I 1977-09-14
K771571 MOBILE X-RAY SYS. MODEL 43820A Hewlett-Packard Co. IZL Class II 1977-08-25
K771549 VERSATOME Kermath Mfg. Corp. IZF Class II 1977-08-25
K771433 AUTO. DEVEL. UNIT FOO DENTAL X-RAY Ada Products Co., Inc. EGY Class II 1977-08-19
K771358 CLINAC 20 Varian Assoc., Inc. IYE Class II 1977-08-16
K771485 PET-TV X-RAY IMAGE INTENSIFIER SYSTEM Diagnostic Information, Inc. JAA Class II 1977-08-16
K771291 IMAGE SCANNING TYPE SONOLAY. SAL-10A Toshiba Medical Systems IYO Class II 1977-08-16
K771301 DIGITAL RADIATION DETECTOR Actus, Inc. IZD Class I 1977-08-04
K771295 X-RAY GENERATOR MODEL KX0-825 Toshiba Medical Systems IZO Class I 1977-08-03
K771293 X-RAY DIAG. TABLE DT-KCS Toshiba Medical Systems IXR Class II 1977-08-03
K771296 TUBE CONVEYOR MODEL DS-PB-4 Toshiba Medical Systems IZF Class II 1977-08-03
K771290 CONTACT COMPOUNT SONOLAY. SAC-10A Toshiba Medical Systems IYO Class II 1977-08-03
K771294 X-RAY GENERATOR MODEL KXO-15 Toshiba Medical Systems IZO Class I 1977-08-03
K771260 LINEAR ACCELERATOR G-2900 Atomic Energy of Canada IYE Class II 1977-08-03
K771297 TUBESTAND MODEL DS-TA-4 Toshiba Medical Systems IZF Class II 1977-08-03
K770693 X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC Xonics Medical Systems, Inc. IZH Class II 1977-08-03
K771298 6 L.L. SYSTEM Toshiba Medical Systems JAA Class II 1977-08-03
K771223 GRAY TONE IMAGING FILM Eastman Kodak Company IWZ Class I 1977-07-14
K770954 UNIVUE I Union Carbide Corp. IYX Class I 1977-07-01
K771096 TELHTHERAPY SIMULATOR AECL-CP, G-3200 Atomic Energy of Canada JAA Class II 1977-07-01
K770903 STERILE CONTINER, X-RAY CASSETTE HOLDER North Shore Orthopaedic Group, S.C. IZL Class II 1977-06-29
K771082 DELTASCAN 2000 SERIES Ohio Nuclear, Inc. JAK Class II 1977-06-24
K771051 C-ARM X-RAY SYSTEM General Electric Co. KPR Class II 1977-06-24
K770837 SCREEN, FINE, LANES, KODAK Eastman Kodak Company EAM Class I 1977-05-26
K770836 ULTIMAT L4 X L4, LIEBEL-FLARSHEIM Mallinckrodt Group, Inc. KPX Class II 1977-05-26
K770855 SYNERVIEW MODEL 6478 Philips Medical Systems (Cleveland), Inc. JAK Class II 1977-05-26
K770753 PORTA CAMERA IIC General Electric Co. IYX Class I 1977-05-10
K770783 FILM PROCESSOR, AUTOMATIC General Electric Co. EGY Class II 1977-05-10
K770515 DISPENSER, TECHNETIUM, CLINTICHEM Union Carbide Corp. KPT Class II 1977-04-05
K770531 UNICAM I Union Carbide Corp. IYX Class I 1977-04-05
K770530 CLEON IMAGER Union Carbide Corp. JAM Class I 1977-04-05
K770574 CRONEX QUANTA III INTENSIFYING SCREENS E.I. Dupont DE Nemours & Co., Inc. EAM Class I 1977-04-05
K770573 ACTA-SCANNER R 0200FS Pfizer Medical Systems, Inc. JAK Class II 1977-03-30
K770407 SHIELD, DENTAL X-RAY, PROTECTIVE Worldwide Dental, Inc. IWO Class I 1977-03-15
K770337 FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. Litton Medical Systems JAA Class II 1977-03-01
K770338 X-RAY CONTROL & X-RAY HV GENERATOR Litton Medical Systems IZO Class I 1977-03-01
K770336 X-RAY TUBE, ROTATING ANODE Litton Medical Systems ITY Class I 1977-03-01
K770334 TILTING X-RAY TABLE Litton Medical Systems IXR Class II 1977-03-01
K770333 FLUOROSCOPE, C-ARM Litton Medical Systems JAA Class II 1977-03-01
K770335 COLLIMATOR, AUTOMATIC Litton Medical Systems KPW Class II 1977-02-28
K770343 MAXICAMERA II General Electric Co. IYX Class I 1977-02-28
K770220 RADIONUCLIDE COMPUTED TOMOGRAPHY SYS. G.D. Searle and Co. KPS Class II 1977-02-28
K770202 CTM (CLINAC TREATMENT MONITOR) Varian Assoc., Inc. KPQ Class II 1977-02-07
K770060 X-RAY POSITIONING DEVICE Robert R. Moore KPR Class II 1977-01-24
K770094 FLUORICON 500 IMAGE INTENSIFIERS General Electric Co. EAM Class I 1977-01-21
K770007 MPX 100 General Electric Co. IZO Class I 1977-01-18
K770006 MPX 80 General Electric Co. IZO Class I 1977-01-18
K770008 MPX 125 General Electric Co. IZO Class I 1977-01-18
K760846 PAKOSTAT II Pako Corp. EGW Class II 1977-01-07
K761339 RADIAL TRAVEL SPEC. PROCEDURES TABLE Xre Corp. IZZ Class II 1977-01-05
K761330 SYNTEX SYSTEM 6000 Syntex Corp. JAK Class II 1976-12-30
K761332 HI-SENSITIVITY MODE OPTION FOR S60-1A Syntex Corp. JAK Class II 1976-12-30

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