Product Code: IXR FDA class 2 21 CFR 892.1980

Table, Radiographic, Tilting

Radiology

A tilting radiographic table is a patient support table capable of rotating from horizontal to vertical positions, used to perform radiographic examinations requiring changes in patient orientation, such as barium swallow studies and fluoroscopic evaluations. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXR, regulated under 21 CFR 892.1980, within the Radiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: IXR
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 77 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K000412	VISION R/F TILTING TABLE	Apr 24, 2000	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K973039	LEGACY/LEGACY-D TABLE	Oct 16, 1997	Substantially Equivalent	GE Medical Systems
K971128	CAP-35B III/CINE 275	Apr 28, 1997	Substantially Equivalent	Jamieson Film Co.
K970640	PHILIPS EASY DIAGNOST	Mar 21, 1997	Substantially Equivalent	Philips Medical Systems North America, Inc.
K965105	ELECTROPHYSIOLOGY TILT TABLE MODEL #9660	Jan 30, 1997	Substantially Equivalent	U.S. Imaging Tables, Inc.
K965096	FLUOROVIEW SERIES FLUOROSCOPIC TABLES	Jan 27, 1997	Substantially Equivalent	U.S. Imaging Tables, Inc.
K963851	TILTING RADIOGRAPHIC TABLE (REMOTE)	Jan 23, 1997	Substantially Equivalent	Acoma Medical Imaging, Inc.
K961022	TANGENT VI TABLE	May 03, 1996	Substantially Equivalent	Fischer Imaging Corp.
K954356	COMPAX 90/15E	Oct 07, 1995	Substantially Equivalent	General Electric Co.
K953557	SURGICAL C-ARM TABLE, 9610	Sep 26, 1995	Substantially Equivalent	U.S. Imaging Tables, Inc.
K953556	VACS TABLE, 9650	Sep 26, 1995	Substantially Equivalent	U.S. Imaging Tables, Inc.
K951176	KOORDINAT M	Apr 20, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K950981	ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650	Apr 03, 1995	Substantially Equivalent	Biodex Medical Systems, Inc.
K950402	CORSINI 9090	Mar 31, 1995	Substantially Equivalent	C.A.T. DI Corsini G. & C. Spa
K945842	MOBILIX MOBILE X-RAY TABLE	Jan 18, 1995	Substantially Equivalent	GE Medical Systems
K943581	HYDRADJUST IV UROLOGICAL TABLE	Jan 04, 1995	Substantially Equivalent	Mallinckrodt Group, Inc.
K944987	URO - ELITE TABLE ACCESSORIES	Nov 30, 1994	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K935444	OCTOSTOP(R) CHAIR (NEW MODEL	Sep 02, 1994	Substantially Equivalent	Octostop, Inc.
K940721	CLINIX VP 4 TABLE	May 03, 1994	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K934574	MODEL MPFT-01, GENESIS	Mar 04, 1994	Substantially Equivalent	International Medical Designs, Inc.
K931563	SPECTRUM MARK I SPECIAL PROCEDURES TABLE	Aug 23, 1993	Substantially Equivalent	Spectrum X-Ray Corp.
K924326	ARTHRODYN 45 DEGREE X-RAY TABLE	Apr 08, 1993	Substantially Equivalent	Arthrodyn, Inc.
K925175	SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90	Nov 27, 1992	Substantially Equivalent	Shimadzu Medical Systems
K922591	UROLOGICAL C-ARM TABLE, MODEL #056-450	Nov 27, 1992	Substantially Equivalent	Biodan Medical Systems, Ltd.
K922364	DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST	Sep 04, 1992	Substantially Equivalent	Toshiba America Medical Systems, In.C
K920726	UROLOGICAL X-RAY TABLE HS-10A	May 29, 1992	Substantially Equivalent	Shimadzu Medical Systems
K920728	X-RAY DIAGNOSTIC TABLE YSF-100	May 28, 1992	Substantially Equivalent	Shimadzu Medical Systems
K920742	HYDRAJUST IV UROLOGICAL TABLE	Apr 27, 1992	Substantially Equivalent	Mallinckrodt Group, Inc.
K920722	X-RAY DIAGNOSTIC TABLE YSF-200-30-90	Apr 13, 1992	Substantially Equivalent	Shimadzu Medical Systems
K914417	MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE	Feb 27, 1992	Substantially Equivalent	Med-Vac, Inc.
K912996	MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE	Feb 03, 1992	Substantially Equivalent	Continental X-Ray Corp.
K915853	TANGENT V	Jan 24, 1992	Substantially Equivalent	Fischer Imaging Corp.
K914165	X-RAY TABLE	Nov 05, 1991	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K912741	ELITE R 90/15	Oct 04, 1991	Substantially Equivalent	Fischer Imaging Corp.
K913147	SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100	Sep 19, 1991	Substantially Equivalent	Shimadzu Medical Systems
K910838	TREATMENT TABLE	Aug 07, 1991	Substantially Equivalent	Tri W-G, Inc.
K912586	TANGENT IV	Aug 02, 1991	Substantially Equivalent	Fischer Imaging Corp.
K911098	PHILIPS URO DIAGNOST MRF	Jul 03, 1991	Substantially Equivalent	Philips Medical Systems, Inc.
K911267	RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004	Apr 03, 1991	Substantially Equivalent	Tri W-G, Inc.
K905265	620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB	Jan 23, 1991	Substantially Equivalent	Tri W-G, Inc.
K905501	ELITE 5000	Jan 18, 1991	Substantially Equivalent	Fischer Imaging Corp.
K905153	REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110	Dec 11, 1990	Substantially Equivalent	Shimadzu Medical Systems
K905152	REMOTE CONTROLLED X-RAY DIAG. RSZ-200	Dec 11, 1990	Substantially Equivalent	Shimadzu Medical Systems
K901654	MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE	Nov 23, 1990	Substantially Equivalent	Imt America, Inc.
K902989	G.E. MONITROL 90 AND G.E. MONITROL 15	Oct 29, 1990	Substantially Equivalent	Electromek Diagnostic Systems, Inc.
K903422	MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE	Sep 04, 1990	Substantially Equivalent	Imt America, Inc.
K903395	UROMAT 2000	Aug 30, 1990	Substantially Equivalent	Pausch Corp.
K896583	F.A.S.T. TABLE	Mar 01, 1990	Substantially Equivalent	Oec-Diasonics, Inc.
K896119	RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE	Nov 27, 1989	Substantially Equivalent	Rms Div.
K896324	ELITE 1500 RADIOGRAPHIC TILTING TABLE	Nov 21, 1989	Substantially Equivalent	Rms Div.
K893673	RMS 180	Jul 20, 1989	Substantially Equivalent	Fischer Imaging Corp.
K892226	TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE	Apr 26, 1989	Substantially Equivalent	Tecnomed, Inc.
K884531	BETA 90/50 MOBILE IMAGING TABLE	Jan 11, 1989	Substantially Equivalent	Beta Medical Products Co.
K883863	GENESIS 180	Oct 21, 1988	Substantially Equivalent	Fischer Imaging Corp.
K883162	TELESTATIX X-RAY TABLE	Sep 06, 1988	Substantially Equivalent	Bay X-Ray, Inc.
K883153	UNDISTAT WITH EXPLORATOR 35 (UCS 35E)	Sep 06, 1988	Substantially Equivalent	Bay X-Ray, Inc.
K882019	SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE	May 31, 1988	Substantially Equivalent	General Electric Co.
K880529	CEILING MOUNTED TILTING TABLE TANGENT III	Mar 03, 1988	Substantially Equivalent	Fischer Imaging Corp.
K874114	TRAUMA TABLE II	Nov 16, 1987	Substantially Equivalent	Xre Corp.
K874113	OMNI DIAGNOST	Nov 16, 1987	Substantially Equivalent	Xre Corp.
K870707	PENTAMAX 1 MODEL B TABLE SYSTEM	May 14, 1987	Substantially Equivalent	Spectrum X-Ray Corp.
K854478	REI-90/90 RADIOGRAPHIC TABLE	Apr 17, 1986	Substantially Equivalent	Radiological Engineering, Inc.
K860913	SIREGRAPH D	Apr 01, 1986	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K854486	TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE	Jan 10, 1986	Substantially Equivalent	Absolute X-Ray Corp.
K854085	OMNI PLANE SYSTEM	Oct 28, 1985	Substantially Equivalent	Xre Corp.
K853175	REI-90/15	Oct 10, 1985	Substantially Equivalent	Radiological Engineering, Inc.
K850948	TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER	Apr 10, 1985	Substantially Equivalent	D&R X-Ray Products, Inc.
K843926	PRESTILIX 1690	Dec 17, 1984	Substantially Equivalent	Cgr Medical Corp.
K840227	UROLIX-3 UROLOGICAL TABLE	Mar 23, 1984	Substantially Equivalent	Medicor USA , Ltd.
K840226	MOTOR TILTED EXAM. TABLE UV-56	Mar 16, 1984	Substantially Equivalent	Medicor USA , Ltd.
K792645	TRIOSKOP	Jan 28, 1980	Substantially Equivalent	Siemens Corp.
K792326	HILO TRANS-X TRAUMA TRANSPORT	Jan 28, 1980	Substantially Equivalent	Tecnomed, Inc.
K791812	SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM	Nov 05, 1979	Substantially Equivalent	Spectrum X-Ray Corp.
K781532	UROSKOP A AND B	Sep 14, 1978	Substantially Equivalent	Siemens Corp.
K771293	X-RAY DIAG. TABLE DT-KCS	Aug 03, 1977	Substantially Equivalent	Toshiba Medical Systems
K770334	TILTING X-RAY TABLE	Mar 01, 1977	Substantially Equivalent	Litton Medical Systems
K760466	TABLE, X-RAY, RFX CLASSICAL	Aug 26, 1976	Substantially Equivalent	General Electric Co.