Product Code: ITY FDA class 1 21 CFR 892.1760

Assembly, Tube Housing, X-Ray, Diagnostic

Radiology

A diagnostic X-ray tube housing assembly is the structural and shielding enclosure that contains the X-ray tube, providing electrical insulation, radiation shielding, and mechanical support for the tube within diagnostic X-ray imaging systems. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITY, regulated under 21 CFR 892.1760, within the Radiology medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code ITY in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: ITY
Device Class: FDA class 1
Regulation Number: 892.1760
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 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K000052	X-RAY MONOBLOCK, MONOBLOCK XRS-60-330	Feb 10, 2000	Substantially Equivalent	Dynarad Corp.
K933162	MRX-750	Oct 07, 1993	Substantially Equivalent	Mrx Corp.
K923094	MOLYBDENUM	Mar 04, 1993	Substantially Equivalent	Southeastern Medical Diagnostics, Inc.
K923141	PHILIPS PRE-FILTER OPTION	Jan 21, 1993	Substantially Equivalent	Philips Medical Systems, Inc.
K921129	MRX-700	Oct 05, 1992	Substantially Equivalent	Mrx-Ray Tube Corp.
K921130	MRX-865	Sep 10, 1992	Substantially Equivalent	Mrx-Ray Tube Corp.
K921316	MG-1001 TUBE HOUSING ASSEMBLY	Jun 22, 1992	Substantially Equivalent	Magma Corp.
K920731	X-RAY TUBE ASSEMBLY CIRCLEX1.2UG	May 29, 1992	Substantially Equivalent	Shimadzu Medical Systems
K920724	HIGH SPEED ROTATION STARTER SA-50	Apr 27, 1992	Substantially Equivalent	Shimadzu Medical Systems
K920723	HIGH SPEED ROTATION STARTER SA-40	Apr 27, 1992	Substantially Equivalent	Shimadzu Medical Systems
K920387	CIRCLEXO.3T X-RAY TUBE ASSEMBLY	Apr 14, 1992	Substantially Equivalent	Shimadzu Medical Systems
K913987	OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID	Apr 13, 1992	Substantially Equivalent	Codman & Shurtleff, Inc.
K913301	MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM	Aug 28, 1991	Substantially Equivalent	Comet North America, Inc.
K912338	TUBE HOUSING ASSEMBLIES	Aug 07, 1991	Substantially Equivalent	Comet Ltd. C/O Radiology Resources, Inc.
K911695	VARIOUS X-RAY TUBES	Jun 19, 1991	Substantially Equivalent	Comet Ltd. C/O Radiology Resources, Inc.
K910308	X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110	Mar 27, 1991	Substantially Equivalent	Inmark Corp.
K910842	DI2000/HS-45-150 X-RAY TUBE INSERT	Mar 06, 1991	Substantially Equivalent	Comet Ltd. C/O Radiology Resources, Inc.
K910276	X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51	Mar 06, 1991	Substantially Equivalent	Inmark Corp.
K904182	R-800-SF	Nov 13, 1990	Substantially Equivalent	Advantech
K900367	HOFMANN-NAGEL (HOFNA) X-RAY TUBES	Feb 26, 1990	Substantially Equivalent	Hofmann
K894742	RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS	Oct 27, 1989	Substantially Equivalent	Inmark Corp.
K894413	X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS	Sep 22, 1989	Substantially Equivalent	Inmark Corp.
K882939	NIOBI-X RADIATION REDUCTION FILTER	Nov 04, 1988	Substantially Equivalent	American Canadian Products, Inc.
K882323	MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000	Jun 30, 1988	Substantially Equivalent	Meicor, Inc.
K873314	TOSHIBA, SMIT ROENTGEN	Nov 02, 1987	Substantially Equivalent	Inland Tube Corp.
K871227	LES RAD FILTER	Jun 29, 1987	Substantially Equivalent	M. D. Products
K870071	TOSHIBA, SMIT ROENTGEN	Jan 21, 1987	Substantially Equivalent	North American Imaging, Inc.
K864042	MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH	Oct 27, 1986	Substantially Equivalent	Absolute X-Ray Corp.
K860760	ERBIUM X-RAY FILTER	Jun 10, 1986	Substantially Equivalent	Reactor Experiments, Inc.
K860504	36-101 XDS111 XENON DELIVERY/TRAP SYSTEM	Apr 04, 1986	Substantially Equivalent	Victoreen, Inc.
K840135	CRISA	Mar 23, 1984	Substantially Equivalent	X-Ray Tube Corp.
K834306	PHASIX-HIGH FREQUENCY GENERATOR	Dec 29, 1983	Substantially Equivalent	Cgr Medical Corp.
K833847	CRISA	Dec 12, 1983	Substantially Equivalent	X-Ray Tube Corp.
K833238	CRISA	Oct 28, 1983	Substantially Equivalent	X-Ray Tube Corp.
K812915	MX 125	Nov 24, 1981	Substantially Equivalent	General Electric Co.
K810190	OPTI 110/12/50HSG	Mar 02, 1981	Substantially Equivalent	Siemens Corp.
K781524	MAXIRAY 125 TUBE UNIT	Oct 17, 1978	Substantially Equivalent	General Electric Co.
K781540	OPTI 110/12/50 HSG	Sep 14, 1978	Substantially Equivalent	Siemens Corp.
K770336	X-RAY TUBE, ROTATING ANODE	Mar 01, 1977	Substantially Equivalent	Litton Medical Systems
K760604	EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS.	Sep 13, 1976	Substantially Equivalent	Eureka X-Ray Tube Corp.