Product Code: IZZ FDA class 2 21 CFR 892.1980

Table, Radiographic, Non-Tilting, Powered

Radiology

A non-tilting powered radiographic table is a motorized patient support surface used for positioning patients during X-ray examinations, providing smooth movement in horizontal planes without a tilting function. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is IZZ, regulated under 21 CFR 892.1980, within the Radiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: IZZ
Device Class: FDA class 2
Regulation Number: 892.1980
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 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K971452	MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE	May 14, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K952701	MED-TRON SPECT IMAGING TABLE	Jul 06, 1995	Substantially Equivalent	Med-Tron Products, Inc.
K951315	CATHETERIZATION TABLE KS-60	May 11, 1995	Substantially Equivalent	Shimadzu Medical Systems
K951053	ANGIOREX CAT-350B	Apr 06, 1995	Substantially Equivalent	Toshiba America Medical Systems, In.C
K943926	RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE	Nov 28, 1994	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K930273	ALPHA	Jul 13, 1993	Substantially Equivalent	Raymax Medical Corp.
K924444	B-4 FOUR-WAY RADIOGRAPHIC TABLE	Feb 05, 1993	Substantially Equivalent	Control-X, Inc.
K925174	SHIMADZU RADIOGRAPHIC TABLE BK-100	Nov 27, 1992	Substantially Equivalent	Shimadzu Medical Systems
K921501	DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004	May 15, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K920732	CATHERIZATION KS-50	Apr 16, 1992	Substantially Equivalent	Shimadzu Medical Systems
K915413	CAT-250B	Dec 19, 1991	Substantially Equivalent	Toshiba America Medical Systems, In.C
K912516	CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111	Nov 19, 1991	Substantially Equivalent	Continental X-Ray Corp.
K912474	CLASSIC 4-WAY ELEVATING TABLE	Sep 16, 1991	Substantially Equivalent	Continental X-Ray Corp.
K903921	MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE	Dec 04, 1990	Substantially Equivalent	Imt America, Inc.
K896665	EXT-600 TABLE, RADIOGRAPHIC, ELEVATING	Jan 22, 1990	Substantially Equivalent	Rms Div.
K894188	GX-ELEVATOR	Oct 03, 1989	Substantially Equivalent	Gendex Corp.
K893452	EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM	Jun 22, 1989	Substantially Equivalent	Warner-Lambert Co.
K891403	HUGH YOUNG II UROLOGICAL TABLE	Jun 22, 1989	Substantially Equivalent	Mallinckrodt Group, Inc.
K893129	CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB	Jun 01, 1989	Substantially Equivalent	Continental X-Ray Corp.
K884930	COMPAX MODEL 40, 400, 400T	Dec 22, 1988	Substantially Equivalent	General Electric Co.
K883974	TANGENT II	Oct 20, 1988	Substantially Equivalent	Fischer Imaging Corp.
K861940	RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T	May 29, 1986	Substantially Equivalent	D&R X-Ray Products, Inc.
K840156	PROTECTA COAT SPONGES	Mar 23, 1984	Substantially Equivalent	Alimed, Inc.
K834494	SPECTRUM X-RAY CORP	Feb 21, 1984	Substantially Equivalent	Spectrum X-Ray Corp.
K827928	VRT TABLE	Sep 29, 1982	Substantially Equivalent	General Electric Co.
K792169	HORIZONTAL RADIOGRAPHIC 4/WAY FLOATING	Dec 10, 1979	Substantially Equivalent	Bennett X-Ray Corp.
K772283	RX PEDESTAL TABLE	Dec 15, 1977	Substantially Equivalent	General Electric Co.
K771601	X-RAY REMOTE CONTROL TABLE	Sep 20, 1977	Substantially Equivalent	Toshiba Medical Systems
K761339	RADIAL TRAVEL SPEC. PROCEDURES TABLE	Jan 05, 1977	Substantially Equivalent	Xre Corp.