meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
1980-05-14

Clearances · page 145 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K800761 POINT TO POINT LEVEL Radiation Products Design, Inc. IYE Class II 1980-05-14
K800788 SIREGRAPH C Siemens Medical Solutions USA, Inc. KPR Class II 1980-05-14
K800824 MODEL SKI-200 ABDOMINAL SCANNER Smithkline Diagnostics, Inc. IYO Class II 1980-05-14
K800652 MODEL E03 ECHO-OPTHALMOSCOPE Kt Medical, Inc. IYO Class II 1980-05-14
K800792 ADJUSTABLE HEAD & FACE HOLDER Radiation Products Design, Inc. IYE Class II 1980-05-14
K800639 ORBITOR Philips Medical Systems (Cleveland), Inc. JAA Class II 1980-05-14
K800751 RADX VENT-AL MECHANICAL RESPORATOR Radx Corp. KPX Class II 1980-05-08
K800564 GENERAL ELECTRIC RADVIEW MARK I SYSTEM General Electric Co. KPR Class II 1980-05-02
K800134 HOPE MODEL 126, AUTO/PROCES., DEN. FLM Hope Industries, Inc. IWZ Class I 1980-05-02
K800101 4200 ME ECHOENCEPHALOGRAPH Kt Medical, Inc. IYO Class II 1980-05-02
K800532 S.K. DIAG. ULTRASOUND BODY SCANNER Smithkline Diagnostics, Inc. IYO Class II 1980-04-10
K800434 PORTABLE MEDICAL ULTRASOUND SCANNER Bion Ent., Ltd. IYO Class II 1980-04-10
K800554 MULTI-FORMAT SFD MODEL 1720 Philips Medical Systems (Cleveland), Inc. IXL Class II 1980-04-10
K800531 S.K. DIAG. ULTRASND. SMALL PARTS SCAN Smithkline Diagnostics, Inc. IYO Class II 1980-04-10
K800320 CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. Amersham Corp. IWJ Class I 1980-03-25
K800489 LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 Atc Medical Technology, Inc. IWE Class I 1980-03-25
K800223 PATIENT POSITIONING SYSTEM 1D OR 2D Laboratoire National D'Essais IWE Class I 1980-03-03
K800100 7200 MA ECHO-OPHTHALMOSCOPE Kt Medical, Inc. IYO Class II 1980-02-21
K800099 INTRACULA II Kt Medical, Inc. IYO Class II 1980-02-21
K791766 ECHO-OCULOMETER #3000 Jedmed Instrument Co. IYO Class II 1980-02-19
K792721 HUESTIS FLEXI-HOLDER Huestis Machine Corp. IXA Class II 1980-02-19
K800139 SEARLE PHO/SONIC ALPHA 2000 G.D. Searle and Co. IYO Class II 1980-02-11
K800097 MINIVASON 9 Kt Medical, Inc. JAF Class II 1980-02-11
K800091 COMBISON 100-MODEL 100 & 110 Kt Medical, Inc. IYO Class II 1980-02-11
K800096 AMBIVASON DR-200 Kt Medical, Inc. JAF Class II 1980-02-11
K800094 COMBISON 200 & COMBISON 202 Kt Medical, Inc. IYO Class II 1980-02-11
K792492 UCA GEL Vanaray Laboratories, Inc. IYO Class II 1980-02-05
K792489 UCA CREAM Vanaray Laboratories, Inc. IYO Class II 1980-02-05
K792665 PIXIE Porta Ray, Inc. IZL Class II 1980-01-29
K792645 TRIOSKOP Siemens Corp. IXR Class II 1980-01-28
K792603 COMPUTED TOMOGRAPHY X-RAY SCANNER Ohio Nuclear, Inc. JAK Class II 1980-01-28
K792326 HILO TRANS-X TRAUMA TRANSPORT Tecnomed, Inc. IXR Class II 1980-01-28
K792638 HIGH RESOLUTION IMAGING SYSTEM Unirad Corp. IYO Class II 1980-01-28
K792585 SMV 120 SONIC MAMMOGRAPHIC VIEWER Johnson & Johnson Professionals, Inc. IYO Class II 1980-01-21
K791959 POST EXTRA SYSTOLIC POSTENTLATOR Medrad, Inc. IXO Class I 1980-01-09
K792517 KODAK X-OMAT RP FILM Eastman Kodak Company IWZ Class I 1980-01-09
K792448 KODAK X-OMAT G FILM Eastman Kodak Company IWZ Class I 1980-01-09
K792317 SR 301 MEDICAL X-RAY FILM E.I. Dupont DE Nemours & Co., Inc. IWZ Class I 1980-01-09
K792293 KODAK ORTHO G FILM Eastman Kodak Company IWZ Class I 1980-01-09
K792178 KODAK CFN FILM SO-224 Eastman Kodak Company IWZ Class I 1980-01-09
K792434 KODAK X-OMAT M20 PROCESSOR, MODEL 2 Eastman Kodak Company IWZ Class I 1980-01-09
K792435 KODAK X-OMAT M20 PROCESSOR, MODEL 1 Eastman Kodak Company IWZ Class I 1980-01-09
K792446 ADR REAL-TIME SECTOR SCANNER Adr Ultrasound IYO Class II 1980-01-09
K792444 NORLAND MODEL 278 BONE DENSITOMETER Norland Corp. KGI Class II 1979-12-27
K792225 P1806 MOBILE C-ARM IMAGE INTENSIFIER Precise Optics JAA Class II 1979-12-20
K792392 POLYPHOS Siemens Corp. IZO Class I 1979-12-20
K792393 GIGANTOS 1012 MP Siemens Corp. IZO Class I 1979-12-20
K792388 OCTOSON Ausonics Pty , Ltd. IYO Class II 1979-12-20
K792327 INTEGRON Tecnomed, Inc. IZF Class II 1979-12-20
K792394 SIRCAM 106 Siemens Corp. IZJ Class II 1979-12-20
K791682 CLEON 720 LARGE FIELD GAMMA CAMERA Union Carbide Corp. IYX Class I 1979-12-13
K792067 VTX (GE CATAOLG NO. B7005A) General Electric Co. IZF Class II 1979-12-10
K792123 KODAK LANEX MED. SCREEN Eastman Kodak Company EAM Class I 1979-12-10
K792169 HORIZONTAL RADIOGRAPHIC 4/WAY FLOATING Bennett X-Ray Corp. IZZ Class II 1979-12-10
K792068 MEMCO 300 FILM CHANGER Memco, Inc. KPX Class II 1979-11-16
K791967 MEVATRON 74X MEDICAL LINEAR ACCELERATOR Siemens Medical Laboratories, Inc. IYE Class II 1979-11-16
K791933 CONVERSION CONTRACTOR TIMER KIT Advanced Instrument Development, Inc. IZO Class I 1979-11-13
K791916 PELICAN BAY KEL-COR CEPHALOMETRIC SYS. Pelican Bay Kel-Cor IXY Class I 1979-11-05
K791812 SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM Spectrum X-Ray Corp. IXR Class II 1979-11-05
K791744 VARIAN V-3400, PHASED ARRAY ULTRASON Varian Assoc., Inc. IYO Class II 1979-10-26
K791755 DATASON-GS General Electric Co. IYO Class II 1979-10-26
K791522 FLOW MEDICAL X-RAY PROTECTIVE GLOVES Flow X-Ray Corp. KPY Class I 1979-10-26
K791811 SPECTRUM AUTOMATIC CHEST UNIT MODEL C Spectrum X-Ray Corp. KPX Class II 1979-10-26
K791830 L/U ARM - NEURO - VASCULAR #B5080B General Electric Co. JAA Class II 1979-10-26
K791775 VARIAN V-3300, PHASED ARRAY ULTRASON Varian Assoc., Inc. IYO Class II 1979-10-26
K791040 SECTOR SCANNER, SDU-100, COMPUTERIZED Shimadzu Corp. IYO Class II 1979-10-04
K791298 DIAGNOSTIC ULTRASOUND SYSTEM Xonics Medical Systems, Inc. IYO Class II 1979-09-27
K791429 EMISONIC 4290 Emi Medical, Inc. IYO Class II 1979-09-21
K791505 ROHNAR 7000 DIGITAL DIAGN ULTRASOUND Roche Scientific Corp. IYO Class II 1979-09-17
K791344 MODEL 1350 GRAPHICS TRANSLATOR Hewlett-Packard Co. IYO Class II 1979-09-17
K791343 MODEL 1338A CRT DISPLAY Hewlett-Packard Co. IYO Class II 1979-09-17
K791055 ADAC TOMOGRAPHY OPTION Adac Laboratories KPS Class II 1979-09-17
K791178 MYVACET 5-07, 7-00 AND 9-40 Radiation Products Design, Inc. IXI Class II 1979-09-17
K791504 AUTOMATIC POSITIVE BEAM COLLIMATOR Dial-X Instruments, Inc. KPW Class II 1979-09-07
K791374 THE MTD VARA SET CASETTE HOLDER Mtd, Inc. KPR Class II 1979-09-07
K791360 KODAK ORTHO M FILM Eastman Kodak Company IWZ Class I 1979-09-04
K790694 BRITT LENS COMPUTER Britt Corp., Inc. IYO Class II 1979-08-10
K791153 ACTA-SCANNER 0220FS Pfizer, Inc. JAK Class II 1979-08-03
K791163 PFIZER 0200FS LOCALLZER Pfizer, Inc. JAK Class II 1979-08-03
K790321 DATASON DB General Electric Co. IYO Class II 1979-08-01
K790975 SOMATOM 2 Siemens Corp. JAK Class II 1979-07-30
K791214 TRIDOROS 712 Siemens Corp. IZO Class I 1979-07-30
K791195 DELTASCAN COMPUTER TOMOGRAPHY X-RAY SCAN Ohio Nuclear, Inc. JAK Class II 1979-07-30
K790942 RADVIEW IMAGER SYSTEM General Electric Co. JAK Class II 1979-06-27
K790783 KOORDINAT 3D Siemens Corp. KXJ Class II 1979-05-07
K790747 MEVATRON 74 Siemens Medical Laboratories, Inc. IYE Class II 1979-05-04
K790673 OMNIMEDICAL AUTOMATIC 1001 Omnimedical IZL Class II 1979-05-04
K790742 KS-78 VERTICAL WALL CASSETTE HOLDER Pausch Corp. IXY Class I 1979-04-26
K790740 BS 66, UNIVERSAL BUCKY STAND Pausch Corp. KPR Class II 1979-04-26
K790741 COMPACT SYSTEM Pausch Corp. KPR Class II 1979-04-26
K790765 MULTIGRAPH Siemens Corp. IZF Class II 1979-04-26
K790688 MEVATRON 67 Siemens Medical Laboratories, Inc. IYE Class II 1979-04-23
K790685 POSI-TOT Victoreen, Inc. KPR Class II 1979-04-23
K790639 GONAD SHIELD The Mochlett Laboratories, Inc. KPY Class I 1979-04-23
K790692 TELEVIX General Electrical Espanola, S.A. KXJ Class II 1979-04-23
K790743 COORDINATUS, HORIZONTAL RADIOGRAPHOC Pausch Corp. KXJ Class II 1979-04-23
K790489 MICROVIEW Philips Medical Systems (Cleveland), Inc. IYO Class II 1979-04-23
K790629 KODAK GRAY TONE IMAGING FILM Eastman Kodak Company IWZ Class I 1979-04-23
K790395 VIDICAM VIDEO REPROGRAPH Vidicam JAK Class II 1979-03-28
K790466 U-MAT Engineering Dynamics Corp. IYX Class I 1979-03-28

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