Product Code: IXQ FDA class 2 21 CFR 892.1980

Table, Radiographic, Stationary Top

Radiology

A stationary-top radiographic table is a patient support table with a fixed, non-tilting tabletop designed to position patients for radiographic examinations, providing a stable, radiolucent surface for X-ray imaging procedures. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXQ, regulated under 21 CFR 892.1980, within the Radiology medical specialty.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: IXQ
Device Class: FDA class 2
Regulation Number: 892.1980
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K973842	CARBON FIBER CONFORMAL COUCH TOP	Dec 05, 1997	Substantially Equivalent	Medtec, Inc.
K960083	MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300	Jul 24, 1996	Substantially Equivalent	Wuestec Medical, Inc.
K954225	MED-TEC HAND GRIP	Nov 14, 1995	Substantially Equivalent	Medtec, Inc.
K946262	EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES	Feb 15, 1995	Substantially Equivalent	Scott Imaging Intl., Inc.
K942916	OCTOPAQUE UNIVERSAL	Sep 08, 1994	Substantially Equivalent	Octostop, Inc.
K942190	ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE	Aug 17, 1994	Substantially Equivalent	Image Diagnostics, Inc.
K913425	DIAL-A-RAD PORTA RAD TABLE	Nov 24, 1992	Substantially Equivalent	Dial-A-Rad
K923775	R-MADE HEAD/ARM SUPPORT	Oct 20, 1992	Substantially Equivalent	R-Made, Inc.
K920729	BUCKY TABLE BK-12	Apr 27, 1992	Substantially Equivalent	Shimadzu Medical Systems
K914351	CLINITRON C-10	Feb 14, 1992	Substantially Equivalent	Ssi Medical Services, Inc.
K912382	MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130	Oct 10, 1991	Substantially Equivalent	Continental X-Ray Corp.
K904187	ECONOMY C-ARM TABLE, MODEL # 056-005	Nov 29, 1990	Substantially Equivalent	Atomic Products Corp.
K904623	RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235	Nov 06, 1990	Substantially Equivalent	Atomic Products Corp.
K903160	LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS	Aug 08, 1990	Substantially Equivalent	Continental X-Ray Corp.
K893690	SUPER SPEED POTTER-BUCKY (ESO5-110 & 220)	Jul 20, 1989	Substantially Equivalent	Hofmann X-Ray of America, Inc.
K892196	RADKOR TS10-B	Apr 26, 1989	Substantially Equivalent	Radkor, Inc.
K873702	REI-38 RADIOGRAPHIC TABLE	Apr 22, 1988	Substantially Equivalent	Radiological Engineering, Inc.
K873849	ALTAIREX BUCKY/CASSETTE TRAY COMBINATION	Oct 28, 1987	Substantially Equivalent	Altairex Manufacturing, Inc.
K862825	HI-LO ELEVATOR FLAT TABLE	Sep 04, 1986	Substantially Equivalent	Garrels X-Ray Products, Inc.
K862826	ITT INTERGRATED TABLE AND TUBESTAND	Aug 01, 1986	Substantially Equivalent	Garrels X-Ray Products, Inc.
K855052	TABLE RADIOGRAPHIC FIXED	Feb 06, 1986	Substantially Equivalent	X-Ray Systems
K842094	XMC-S TUBESTAND XMT-S TABLE XMH-NTWALL	May 24, 1985	Substantially Equivalent	X-Ray Mfg. & Sales, Inc.
K850118	XMA INTEGRATED TABLE	Apr 09, 1985	Substantially Equivalent	Summit Industries, Inc.
K842614	CAROLINA X-RAY CO. SIMPLAFLOAT TABLE	Aug 08, 1984	Substantially Equivalent	Carolina X-Ray Co., Inc.
K781681	PHIPIOLOGICAL SYNCHRONIZER PART#205	Oct 17, 1978	Substantially Equivalent	Brattle Instrument Corp.
K781067	PLURIX B; RADIOGRAPHIC TABLE	Jul 17, 1978	Substantially Equivalent	Tecnomed, Inc.
K781066	PLURIX C; RADIOGRAPHIC TABLE	Jul 17, 1978	Substantially Equivalent	Tecnomed, Inc.