Product Code: IZO FDA class 1 21 CFR 892.1700

Generator, High-Voltage, X-Ray, Diagnostic

Radiology

A diagnostic X-ray high-voltage generator is the power supply component of a radiographic system that converts electrical power into the precise high-voltage output required to produce diagnostic X-rays. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls with no premarket notification requirement. The product code is IZO, regulated under 21 CFR 892.1700, within the Radiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

163

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: IZO
Device Class: FDA class 1
Regulation Number: 892.1700
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 163 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K954666	MPH50, MPH65, AND MPH80	Nov 24, 1995	Substantially Equivalent	GE Medical Systems
K953582	HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR	Sep 26, 1995	Substantially Equivalent	Varian Canada, Inc.
K953831	N 800 HF	Sep 08, 1995	Substantially Equivalent	Nucletron-Oldelft Corp.
K952822	SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G	Jul 12, 1995	Substantially Equivalent	Shimadzu Corp.
K952265	MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR	Jul 06, 1995	Substantially Equivalent	Control-X, Inc.
K950883	POLYDOROS SX 65 AND 80	Apr 03, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K950694	COMPACT-X	Mar 31, 1995	Substantially Equivalent	Electromed Intl., Ltd.
K950291	DIGITAL 625HF	Mar 23, 1995	Substantially Equivalent	Fischer Imaging Corp.
K950041	SII 360 APR	Mar 21, 1995	Substantially Equivalent	Scott Imaging Intl., Inc.
K950040	SII 525 APR	Mar 21, 1995	Substantially Equivalent	Scott Imaging Intl., Inc.
K945453	UD 150L-R II	Mar 21, 1995	Substantially Equivalent	Shimadzu Medical Systems
K945452	UD 150L-F	Mar 21, 1995	Substantially Equivalent	Shimadzu Medical Systems
K950037	N 800 HF	Feb 15, 1995	Substantially Equivalent	Oldelft Corp. of America
K945731	HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS	Feb 15, 1995	Substantially Equivalent	Bennett X-Ray Corp.
K945668	KXO-80G	Dec 27, 1994	Substantially Equivalent	Toshiba America Medical Systems, In.C
K942731	SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR	Oct 13, 1994	Substantially Equivalent	Shimadzu Corp.
K944150	MICRO X-65 HF	Sep 16, 1994	Substantially Equivalent	Fischer Imaging Corp.
K944149	MICRO X-80 HF	Sep 16, 1994	Substantially Equivalent	Fischer Imaging Corp.
K944148	MICRO X-30HF	Sep 16, 1994	Substantially Equivalent	Fischer Imaging Corp.
K944147	MICRO X-50 HF	Sep 16, 1994	Substantially Equivalent	Fischer Imaging Corp.
K943652	VASCULAR MP X-RAY GENERATOR	Aug 22, 1994	Substantially Equivalent	GE Medical Systems
K943504	RSX-525HF	Aug 17, 1994	Substantially Equivalent	Fischer Imaging Corp.
K942778	MODEL VPW2877F8, MAMMO 5 POWER SUPPLY	Jul 29, 1994	Substantially Equivalent	Varian Assoc., Inc.
K942100	MODEL TM EP HIGH VOLTAGE GENERATOR	Jun 07, 1994	Substantially Equivalent	Continental X-Ray Corp.
K934686	MOLYBDENUM/RHODIUM FILTERS	May 26, 1994	Substantially Equivalent	Continental X-Ray Corp.
K940227	SCPU X-RAY GENERATOR	Apr 28, 1994	Substantially Equivalent	General Electric Co.
K935068	RADIOGRAPHIC GENERATOR HFQ-WHIS	Dec 13, 1993	Substantially Equivalent	Bennett X-Ray Corp.
K934967	SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR	Dec 13, 1993	Substantially Equivalent	Shimadzu Corp.
K933777	CONCEPT ONE	Dec 13, 1993	Substantially Equivalent	Innerscan, Inc.
K933471	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G	Nov 24, 1993	Substantially Equivalent	Shimadzu Corp.
K933650	PHILIPS XRG 90 X-RAY GENERATOR SYSTEM	Oct 07, 1993	Substantially Equivalent	Philips Medical Systems North America, Inc.
K933240	POLYDOROS IS	Sep 07, 1993	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K931930	POYDOROS LX	Sep 07, 1993	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K931998	LCR GENERATOR	Jul 27, 1993	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K931049	ADVANTX SYSTEM	May 19, 1993	Substantially Equivalent	GE Medical Systems
K930792	RSX 30HF	May 19, 1993	Substantially Equivalent	Fischer Imaging Corp.
K926365	MAGMA XHF-30, XHF-40, XHF-50	Mar 26, 1993	Substantially Equivalent	Imaging and X-Ray Intl., Inc.
K920351	PCX 650HF RADIOGRAPHIC X-RAY	Feb 12, 1993	Substantially Equivalent	Control-X, Inc.
K920349	PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR	Feb 12, 1993	Substantially Equivalent	Control-X, Inc.
K925684	OLYMP-X,X-RAY GENERATOR	Feb 02, 1993	Substantially Equivalent	Afp Imaging Corp.
K924078	POLYDOROS C	Jan 26, 1993	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K925844	PHILIPS SUPER CP FAMILY	Dec 28, 1992	Substantially Equivalent	Philips Medical Systems, Inc.
K925105	PHILIPS MEDIO CP FAMILY	Dec 28, 1992	Substantially Equivalent	Philips Medical Systems, Inc.
K923786	POLYDOROS XS50 AND SX80	Dec 17, 1992	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K921875	X-RAY CONTROL AND HI-VOLTAGE GENERATOR	Oct 15, 1992	Substantially Equivalent	Continental X-Ray Corp.
K922814	TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT	Sep 11, 1992	Substantially Equivalent	Bay Shore Medical Equipment Corp.
K922165	ATC725, ATC525, AND AP300	Jul 27, 1992	Substantially Equivalent	Gendex Corp.
K921951	MPG 65-80-100 X-RAY GENERATOR AND CONTROL	Jul 21, 1992	Substantially Equivalent	General Electric Co.
K921516	P2900 X-RAY GENERATOR	May 28, 1992	Substantially Equivalent	Precise Optics Photo Medic Equipment, Inc.
K920730	X-RAY HIGH VOLTAGE GENERATOR ED 125L	Apr 27, 1992	Substantially Equivalent	Shimadzu Medical Systems
K915339	GEN-X 800/300	Jan 09, 1992	Substantially Equivalent	Swissray Finatech, Inc.
K915227	GEN-X 800/500	Jan 09, 1992	Substantially Equivalent	Swiss Ray Medical Systems
K913222	OPTIMA	Dec 20, 1991	Substantially Equivalent	Olympic Controls Corp.
K914266	MICRO-X 30 HF	Nov 27, 1991	Substantially Equivalent	Fischer Imaging Corp.
K914236	MICRO-X 50 HF	Nov 27, 1991	Substantially Equivalent	Fischer Imaging Corp.
K913577	MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR	Nov 05, 1991	Substantially Equivalent	Control-X, Inc.
K913578	MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR	Nov 01, 1991	Substantially Equivalent	Control-X, Inc.
K914302	GEN-X 800/650	Oct 30, 1991	Substantially Equivalent	Swissray Finatech, Inc.
K914301	GEN-X 800/800	Oct 30, 1991	Substantially Equivalent	Swissray Finatech, Inc.
K911562	EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR	Oct 24, 1991	Substantially Equivalent	Continental X-Ray Corp.
K913234	VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY	Sep 23, 1991	Substantially Equivalent	Varian Canada, Inc.
K913065	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L	Sep 16, 1991	Substantially Equivalent	Shimadzu Medical Systems
K913064	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L	Sep 16, 1991	Substantially Equivalent	Shimadzu Medical Systems
K913063	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10	Sep 16, 1991	Substantially Equivalent	Shimadzu Medical Systems
K913062	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10	Sep 16, 1991	Substantially Equivalent	Shimadzu Medical Systems
K912449	MICRO-X 15 HF	Aug 28, 1991	Substantially Equivalent	Fischer Imaging Corp.
K911280	SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B	Jun 17, 1991	Substantially Equivalent	Shimadzu Medical Systems
K910650	SELECTOR MD (50KW AND 80 KW)	Jun 06, 1991	Substantially Equivalent	Hofmann-Nagel Medical Systems, Inc.
K911339	SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K	Apr 16, 1991	Substantially Equivalent	Shimadzu Medical Systems
K910020	CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS	Apr 08, 1991	Substantially Equivalent	Capintec Instruments, Inc.
K910820	VPW 2877E6 X-RAY POWER SUPPLY	Mar 07, 1991	Substantially Equivalent	Varian Canada, Inc.
K905695	MICRO-X 80HF	Mar 06, 1991	Substantially Equivalent	Fischer Imaging Corp.
K905799	HFQ SERIES CONTROLS AND GENERATORS	Feb 26, 1991	Substantially Equivalent	Bennett X-Ray Corp.
K904169	VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY	Feb 19, 1991	Substantially Equivalent	Varian Canada, Inc.
K905855	VPW2877E7 X RAY POWER SUPPLY	Feb 13, 1991	Substantially Equivalent	Varian Canada, Inc.
K902986	G.E. DXD 325/350/350II/DXD 525/525II GENERATORS	Feb 13, 1991	Substantially Equivalent	Electromek Diagnostic Systems, Inc.
K904114	ANATECH X-RAY GENERATOR	Jan 03, 1991	Substantially Equivalent	Continental X-Ray Corp.
K902987	G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS	Dec 26, 1990	Substantially Equivalent	Electromek Diagnostic Systems, Inc.
K902988	G.E. MSI 850/850II/1250 THREE PHASE GENERATORS	Dec 19, 1990	Substantially Equivalent	Electromek Diagnostic Systems, Inc.
K902985	G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN	Dec 19, 1990	Substantially Equivalent	Electromek Diagnostic Systems, Inc.
K904043	KXO-80C/80D	Nov 29, 1990	Substantially Equivalent	Toshiba America Medical Systems, In.C
K904397	TEC 1410	Nov 13, 1990	Substantially Equivalent	Bay Shore Medical Equipment Corp.
K903942	SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G	Oct 03, 1990	Substantially Equivalent	Shimadzu Medical Systems
K902106	VPW 2877D5, X-RAY POWER SUPPLY	Aug 10, 1990	Substantially Equivalent	Varian Assoc., Inc.
K902637	FUTURUS 2001 X-RAY GENERATOR	Aug 03, 1990	Substantially Equivalent	Acoma Medical Imaging, Inc.
K901951	MODEL# MPC	Jul 11, 1990	Substantially Equivalent	Amerisys
K900062	U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL	Feb 05, 1990	Substantially Equivalent	U.S. Imaging, Inc.
K895969	RADKOR DXG-650R	Nov 13, 1989	Substantially Equivalent	Radkor, Inc.
K894479	30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE	Sep 12, 1989	Substantially Equivalent	Bennett X-Ray Corp.
K893681	MAMM-AIRE CP	Jul 20, 1989	Substantially Equivalent	Custom Medical Products, Ltd.
K893674	RME 325R	Jul 20, 1989	Substantially Equivalent	Fischer Imaging Corp.
K892657	SENSIMAT	Jun 23, 1989	Substantially Equivalent	Transworld X-Ray Corp.
K892943	MULTI PULSE POWER UNIT GENERATOR	May 22, 1989	Substantially Equivalent	GE Medical Systems
K890083	GX-2000 STATIONARY X-RAY GENERATOR	Mar 31, 1989	Substantially Equivalent	Gendex Corp.
K890066	STAR 36	Mar 28, 1989	Substantially Equivalent	Transworld X-Ray Corp.
K884678	ESP 3-PHASE X-RAY GENERATORS	Jan 17, 1989	Substantially Equivalent	Elscint, Inc.
K883976	CFX 625	Dec 13, 1988	Substantially Equivalent	Fischer Imaging Corp.
K884134	MICRO-X 100CP	Oct 21, 1988	Substantially Equivalent	Fischer Imaging Corp.
K883431	RAYMAX 2100 MODELS 2130 & 2136	Sep 12, 1988	Substantially Equivalent	Raymax Medical Corp.
K883154	SELDIX 325 TWO PULSE GENERATOR/CONTROL	Sep 06, 1988	Substantially Equivalent	Bay X-Ray, Inc.
K883081	RADKOR, XG-515	Sep 02, 1988	Substantially Equivalent	Radkor, Inc.
K881696	RADKOR XG-325	Sep 02, 1988	Substantially Equivalent	Radkor, Inc.
K880525	3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF	Aug 15, 1988	Substantially Equivalent	Fischer Imaging Corp.
K881886	MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L	Aug 04, 1988	Substantially Equivalent	U.S. Imaging, Inc.
K881387	X-RAY GENERATING SYSTEM, TF 800	Jul 08, 1988	Substantially Equivalent	Absolute X-Ray Corp.
K881386	X-RAY GENERATING SYSTEM TF 1000	Jul 08, 1988	Substantially Equivalent	General Medical Merate S.P.A
K881795	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K	Jul 01, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K880524	THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 100	May 04, 1988	Substantially Equivalent	Fischer Imaging Corp.
K880523	THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 75	May 04, 1988	Substantially Equivalent	Fischer Imaging Corp.
K880522	THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 80	May 04, 1988	Substantially Equivalent	Fischer Imaging Corp.
K880521	SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-650	May 04, 1988	Substantially Equivalent	Fischer Imaging Corp.
K880519	SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 650	May 04, 1988	Substantially Equivalent	Fischer Imaging Corp.
K880532	SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350	Mar 28, 1988	Substantially Equivalent	Fischer Imaging Corp.
K874946	SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60	Mar 03, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K880050	EDEC 60R	Feb 29, 1988	Substantially Equivalent	Electromed Intl., Ltd.
K875341	EDEC 60 R/F	Feb 01, 1988	Substantially Equivalent	Electromed Intl., Ltd.
K875342	EDEC 90C	Jan 29, 1988	Substantially Equivalent	Electromed Intl., Ltd.
K873544	MPG-50 X-RAY GENERATOR	Oct 26, 1987	Substantially Equivalent	Thomson-Cgr Medical Corp.
K872445	POWER-AID INDEPENDENT X-RAY POWER SOURCE	Aug 12, 1987	Substantially Equivalent	Advanced Instrument Development, Inc.
K864624	PROBE, UPTAKE, NUCLEAR	Aug 10, 1987	Substantially Equivalent	Carolina Medical Electronics
K872357	TRANSWORLD 360V, MODEL A1-4040	Jul 15, 1987	Substantially Equivalent	Transworld X-Ray Corp.
K871145	EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR	Mar 31, 1987	Substantially Equivalent	Electromed Intl., Ltd.
K870851	EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR	Mar 20, 1987	Substantially Equivalent	Electromed Intl., Ltd.
K864339	PORTA RAY MODEL 325	Dec 15, 1986	Substantially Equivalent	Porta Ray, Inc.
K862800	SMX GENERATOR	Aug 14, 1986	Substantially Equivalent	General Electric Co.
K862682	MVP GENERATOR, CATALOG NO. H8018	Jul 29, 1986	Substantially Equivalent	General Electric Co.
K854499	GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR	Apr 22, 1986	Substantially Equivalent	Gendex Corp.
K860736	FISCHER IMAGING FX325R X-RAY GENERATOR	Apr 17, 1986	Substantially Equivalent	Fischer Imaging Corp.
K860203	TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR	Jan 30, 1986	Substantially Equivalent	Tingle X-Ray Products, Inc.
K852908	EDEC 2000	Nov 29, 1985	Substantially Equivalent	Electromed Intl., Ltd.
K851011	HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR	Apr 10, 1985	Substantially Equivalent	Hofmann X-Ray of America, Inc.
K850823	SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR	Apr 10, 1985	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K850117	XMA 325 (X-RAY GENERATOR)	Apr 09, 1985	Substantially Equivalent	Summit Industries, Inc.
K843443	EDEC-100	Mar 01, 1985	Substantially Equivalent	Electromed Intl., Ltd.
K842348	SPX GENERATOR	Aug 17, 1984	Substantially Equivalent	General Electric Co.
K833846	PROCESS 100 ST	Dec 16, 1983	Substantially Equivalent	Cgr Medical Corp.
K820593	ESP SERIES (X-RAY GENERATORS	Mar 19, 1982	Substantially Equivalent	Xonics Medical Systems, Inc.
K820307	TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE	Mar 05, 1982	Substantially Equivalent	Tecnomed, Inc.
K820112	SIEMENS POLYDOROS 800	Feb 24, 1982	Substantially Equivalent	Siemens Corp.
K813051	COMPTAR III	Nov 24, 1981	Substantially Equivalent	Cgr Medical Corp.
K812616	POLYPHOS 500	Oct 13, 1981	Substantially Equivalent	Siemens Corp.
K811198	ECCO GENERATOR	Jun 29, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K802996	VECTOR-100 X-RAY GENERATOR	Jan 09, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K802941	CINESCOPE III RADIOGRAPHIC GENERATOR	Jan 09, 1981	Substantially Equivalent	Controtec, Inc.
K802551	GENERATOR, HIGH VOLT, X-RAY, MPX100/125	Dec 02, 1980	Substantially Equivalent	General Electric Co.
K802550	GENERATOR, HIGH VOLT, X-RAY, MPX 125	Dec 02, 1980	Substantially Equivalent	General Electric Co.
K802549	GENERATOR, HIGH VOLT, X-RAY, MPX 100	Dec 02, 1980	Substantially Equivalent	General Electric Co.
K802548	GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80	Dec 02, 1980	Substantially Equivalent	General Electric Co.
K801808	BR 2002 X-RAY GENERATOR SYSTEM	Sep 26, 1980	Substantially Equivalent	Valmet Indus. Mach. & Prod., Inc.
K801408	CINESCOPE III	Jul 28, 1980	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K792393	GIGANTOS 1012 MP	Dec 20, 1979	Substantially Equivalent	Siemens Corp.
K792392	POLYPHOS	Dec 20, 1979	Substantially Equivalent	Siemens Corp.
K791933	CONVERSION CONTRACTOR TIMER KIT	Nov 13, 1979	Substantially Equivalent	Advanced Instrument Development, Inc.
K791214	TRIDOROS 712	Jul 30, 1979	Substantially Equivalent	Siemens Corp.
K780742	INTRAORAL DENTAL X-RAY GENERATOR	Jul 27, 1978	Substantially Equivalent	Siemens Corp.
K771295	X-RAY GENERATOR MODEL KX0-825	Aug 03, 1977	Substantially Equivalent	Toshiba Medical Systems
K771294	X-RAY GENERATOR MODEL KXO-15	Aug 03, 1977	Substantially Equivalent	Toshiba Medical Systems
K770338	X-RAY CONTROL & X-RAY HV GENERATOR	Mar 01, 1977	Substantially Equivalent	Litton Medical Systems
K770008	MPX 125	Jan 18, 1977	Substantially Equivalent	General Electric Co.
K770007	MPX 100	Jan 18, 1977	Substantially Equivalent	General Electric Co.
K770006	MPX 80	Jan 18, 1977	Substantially Equivalent	General Electric Co.
K760569	THREE PHASE X-RAY CONTROLS & HV GENERATORS	Sep 15, 1976	Substantially Equivalent	Litton Medical Systems
K760568	SINGLE PHASE X-RAY CONTROLS & HV GENERATORS	Sep 15, 1976	Substantially Equivalent	Litton Medical Systems