Product code IZO

Device name: Generator, High-Voltage, X-Ray, Diagnostic
Medical specialty: Radiology
Device class: 1
Regulation number: 892.1700
Review panel: RA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K954666	MPH50, MPH65, AND MPH80	GE Medical Systems	1995-11-24
K953582	HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR	Varian Canada, Inc.	1995-09-26
K953831	N 800 HF	Nucletron-Oldelft Corp.	1995-09-08
K952822	SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G	Shimadzu Corp.	1995-07-12
K952265	MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR	Control-X, Inc.	1995-07-06
K950883	POLYDOROS SX 65 AND 80	Siemens Medical Solutions USA, Inc.	1995-04-03
K950694	COMPACT-X	Electromed Intl., Ltd.	1995-03-31
K950291	DIGITAL 625HF	Fischer Imaging Corp.	1995-03-23
K950041	SII 360 APR	Scott Imaging Intl., Inc.	1995-03-21
K950040	SII 525 APR	Scott Imaging Intl., Inc.	1995-03-21
K945453	UD 150L-R II	Shimadzu Medical Systems	1995-03-21
K945452	UD 150L-F	Shimadzu Medical Systems	1995-03-21
K950037	N 800 HF	Oldelft Corp. of America	1995-02-15
K945731	HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS	Bennett X-Ray Corp.	1995-02-15
K945668	KXO-80G	Toshiba America Medical Systems, In.C	1994-12-27
K942731	SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR	Shimadzu Corp.	1994-10-13
K944150	MICRO X-65 HF	Fischer Imaging Corp.	1994-09-16
K944149	MICRO X-80 HF	Fischer Imaging Corp.	1994-09-16
K944148	MICRO X-30HF	Fischer Imaging Corp.	1994-09-16
K944147	MICRO X-50 HF	Fischer Imaging Corp.	1994-09-16
K943652	VASCULAR MP X-RAY GENERATOR	GE Medical Systems	1994-08-22
K943504	RSX-525HF	Fischer Imaging Corp.	1994-08-17
K942778	MODEL VPW2877F8, MAMMO 5 POWER SUPPLY	Varian Assoc., Inc.	1994-07-29
K942100	MODEL TM EP HIGH VOLTAGE GENERATOR	Continental X-Ray Corp.	1994-06-07
K934686	MOLYBDENUM/RHODIUM FILTERS	Continental X-Ray Corp.	1994-05-26
K940227	SCPU X-RAY GENERATOR	General Electric Co.	1994-04-28
K933777	CONCEPT ONE	Innerscan, Inc.	1993-12-13
K934967	SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR	Shimadzu Corp.	1993-12-13
K935068	RADIOGRAPHIC GENERATOR HFQ-WHIS	Bennett X-Ray Corp.	1993-12-13
K933471	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G	Shimadzu Corp.	1993-11-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08436046000162	SEDECAL	SEDECAL	2016-10-28
08436046000308	SEDECAL	SEDECAL	2016-10-28
08436046000292	SEDECAL	SEDECAL	2016-10-28
08436046000285	SEDECAL	SEDECAL	2016-10-28
08436046000278	SEDECAL	SEDECAL	2016-10-28
08436046000261	SEDECAL	SEDECAL	2016-10-28
08436046000254	SEDECAL	SEDECAL	2016-10-28
08436046000247	SEDECAL	SEDECAL	2016-10-28
08436046000230	SEDECAL	SEDECAL	2016-10-28
08436046000223	SEDECAL	SEDECAL	2016-10-28
08436046000216	SEDECAL	SEDECAL	2016-10-28
08436046000209	SEDECAL	SEDECAL	2016-10-28
08436046000193	SEDECAL	SEDECAL	2016-10-28
08436046000186	SEDECAL	SEDECAL	2016-10-28
08436046000179	SEDECAL	SEDECAL	2016-10-28
08436046000018	SEDECAL	SEDECAL	2016-10-28
08436046000155	SEDECAL	SEDECAL	2016-10-28
08436046000148	SEDECAL	SEDECAL	2016-10-28
08436046000131	SEDECAL	SEDECAL	2016-10-28
08436046000124	SEDECAL	SEDECAL	2016-10-28
08436046000117	SEDECAL	SEDECAL	2016-10-28
08436046000100	SEDECAL	SEDECAL	2016-10-28
08436046000094	SEDECAL	SEDECAL	2016-10-28
08436046000087	SEDECAL	SEDECAL	2016-10-28
08436046000070	SEDECAL	SEDECAL	2016-10-28
08436046000063	SEDECAL	SEDECAL	2016-10-28
08436046000056	SEDECAL	SEDECAL	2016-10-28
08436046000049	SEDECAL	SEDECAL	2016-10-28
08436046000032	SEDECAL	SEDECAL	2016-10-28
08436046000025	SEDECAL	SEDECAL	2016-10-28

Product code IZO

Related 510(k) Records#

Related GUDID Devices#