Product Code: IYB FDA class 1 21 CFR 892.1770

Tube Mount, X-Ray, Diagnostic

Radiology

A diagnostic X-ray tube mount is the mechanical support and positioning mechanism that holds and allows adjustment of the X-ray tube assembly within a diagnostic radiographic system, enabling precise positioning of the X-ray beam relative to the patient and imaging receptor. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IYB, regulated under 21 CFR 892.1770, within the Radiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: IYB
Device Class: FDA class 1
Regulation Number: 892.1770
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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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
K935123	SUPERSTAND 300	Mar 27, 1996	Substantially Equivalent	Wuestec Medical, Inc.
K946261	MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000	Feb 15, 1995	Substantially Equivalent	Scott Imaging Intl., Inc.
K941017	F/C/W TUBESTAND	Jul 29, 1994	Substantially Equivalent	Acoma Medical Imaging, Inc.
K941004	CTS SYSTEM	Jul 29, 1994	Substantially Equivalent	Acoma Medical Imaging, Inc.
K940442	MPR-814	Jun 09, 1994	Substantially Equivalent	Xri, Inc.
K935004	MODEL ALPHA TS-2	Dec 13, 1993	Substantially Equivalent	Dpa Consulting, Inc.
K933253	SUPERSTAND 3000	Aug 16, 1993	Substantially Equivalent	Wuestec Medical, Inc.
K925716	BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC	Dec 17, 1992	Substantially Equivalent	Bennett X-Ray Corp.
K925170	SHIMADZU X-RAY TUBE STAND BH-100 SERIES	Dec 07, 1992	Substantially Equivalent	Shimadzu Medical Systems
K920727	CEILING TUBE SUPPORT CH-30X	Apr 16, 1992	Substantially Equivalent	Shimadzu Medical Systems
K914944	BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC	Dec 02, 1991	Substantially Equivalent	Bennett X-Ray Corp.
K914348	ER-1000 CATHERIZATION C-ARM SYSTEMS	Nov 01, 1991	Substantially Equivalent	Shimadzu Medical Systems
K911563	INVENTOR RT/EXPLORER TRAUMA UNIT	Oct 23, 1991	Substantially Equivalent	Continental X-Ray Corp.
K912696	TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL	Sep 16, 1991	Substantially Equivalent	Bennett X-Ray Corp.
K900234	PFM-90 CEILING TUBE SUPPORT	Feb 26, 1990	Substantially Equivalent	Fischer Imaging Corp.
K895188	SHIMADZU X-RAY TUBE STAND FH-31	Sep 22, 1989	Substantially Equivalent	Shimadzu Medical Systems
K893653	RADIOGRAPHIC CEILING TUBE SUPPORT CTS15	Jun 23, 1989	Substantially Equivalent	Fischer Imaging Corp.
K893652	RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60	Jun 23, 1989	Substantially Equivalent	Fischer Imaging Corp.
K883664	LUM VASCULAR PROCEDURE SYSTEM #B5200A	Nov 07, 1988	Substantially Equivalent	General Electric Co.
K883864	RADKOR SFR-70	Oct 19, 1988	Substantially Equivalent	Radkor, Inc.
K881701	RADKOR SFC-21	Sep 08, 1988	Substantially Equivalent	Radkor, Inc.
K882563	RADKOR, CST-18	Jul 08, 1988	Substantially Equivalent	Radkor, Inc.
K880530	CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX	Mar 03, 1988	Substantially Equivalent	Fischer Imaging Corp.
K880528	OVERHEAD TUBE MOUNT CASCADE II	Feb 29, 1988	Substantially Equivalent	Fischer Imaging Corp.
K873283	MODEL C2-5000 OVERHEAD TUBE SUPPORT	Sep 10, 1987	Substantially Equivalent	Transworld X-Ray Corp.
K870856	COSMOS	Mar 30, 1987	Substantially Equivalent	Pausch Corp.
K862827	FCW TUBE STAND	Aug 01, 1986	Substantially Equivalent	Garrels X-Ray Products, Inc.
K862734	CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND	Aug 01, 1986	Substantially Equivalent	D&R X-Ray Products, Inc.
K861995	MODEL RS-3 RADIOGRAPHIC STAND	Jun 19, 1986	Substantially Equivalent	Medicor USA , Ltd.
K852952	TRAUMA STAND	Sep 26, 1985	Substantially Equivalent	Xre Corp.
K853682	MOUNT TUBE RADIOGRAPHIC	Sep 19, 1985	Substantially Equivalent	X-Ray Systems
K850198	FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG	May 14, 1985	Substantially Equivalent	Summit Industries, Inc.
K844337	X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY	Feb 21, 1985	Substantially Equivalent	Quality X-Ray Manufacturing, Inc.
K843928	COUNTERBALANCED VERTICAL CASSETTE HOLDER	Dec 17, 1984	Substantially Equivalent	Poersch Metal Mfg. Co.
K843335	FLOOR MOUNTED X-RAY TUBESTAND	Nov 27, 1984	Substantially Equivalent	Medicor USA , Ltd.
K811970	AP X-RAY TUBE ANGULATION DEVICE	Aug 13, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K811195	ARGOSTAT	Jun 09, 1981	Substantially Equivalent	Tecnomed, Inc.
K803162	X-RAY STAND & OPERATING CHAIR	Jan 28, 1981	Substantially Equivalent	Downs Surgical , Ltd.
K781571	L/U ARM-VASCULAR	Nov 27, 1978	Substantially Equivalent	General Electric Co.
K781065	PLURIMAT;RADIOGRAPHIC TUBE MOUNT	Jul 17, 1978	Substantially Equivalent	Tecnomed, Inc.