Product Code: KXJ FDA class 2 21 CFR 892.1980

Table, Radiologic

Radiology

The Radiologic Table is a specialized examination table designed to support patients during X-ray, fluoroscopy, or other radiologic imaging procedures, often incorporating features for table movement and positioning to optimize image acquisition. It is classified as FDA Class 2, indicating moderate risk, and is subject to general controls and special controls, though premarket notification has not been required for this category. The product code is KXJ, regulated under 21 CFR 892.1980, in the Radiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KXJ
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 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K050190	APOLLO	Mar 25, 2005	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K963905	RADIOGRAPHIC ITT TABLE	Nov 12, 1996	Substantially Equivalent	X-Ray Technologies, Inc.
K955414	XRT 400	Jul 24, 1996	Substantially Equivalent	Wuestec Medical, Inc.
K951146	IMAGING TABLE	May 04, 1995	Substantially Equivalent	Septa Corp.
K950068	CARBON FIBER COUCH INSERT	Apr 06, 1995	Substantially Equivalent	Medtec, Inc.
K950442	INFRARED EXPOSURE HAND SWITCH	Mar 31, 1995	Substantially Equivalent	Medical X-Ray Intl., Inc.
K940696	SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5	Mar 16, 1994	Substantially Equivalent	Philips Medical Systems North America, Inc.
K931724	ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES	Jun 14, 1993	Substantially Equivalent	Continental X-Ray Corp.
K926407	MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM	Mar 31, 1993	Substantially Equivalent	Nucletron-Oldelft Corp.
K922098	CAG-02A	Jul 27, 1992	Substantially Equivalent	Toshiba America Medical Systems, In.C
K913121	OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400	Aug 16, 1991	Substantially Equivalent	Continental X-Ray Corp.
K883885	RADKOR, RF-159	Oct 19, 1988	Substantially Equivalent	Radkor, Inc.
K883155	RASTIX X-RAY TABLE	Sep 06, 1988	Substantially Equivalent	Bay X-Ray, Inc.
K881700	RADKOR KOB-84	Sep 02, 1988	Substantially Equivalent	Radkor, Inc.
K874934	UNIVERSAL EXAMINATION TABLE	Jan 19, 1988	Substantially Equivalent	Imatron, Inc.
K874639	REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100	Dec 04, 1987	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K871827	OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER	Jun 19, 1987	Substantially Equivalent	General Electric Co.
K862144	X-MAT	Jun 25, 1986	Substantially Equivalent	Combined Concepts, Inc.
K860620	SHAMPAINE RADI-OP MODEL 1700RC	Apr 08, 1986	Substantially Equivalent	Smith & Nephew, Inc.
K854328	MEDEX X-RAY TABLE	Jan 28, 1986	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K834478	CHICK/REISON PATIENT EMERG. TROLLEY	Feb 21, 1984	Substantially Equivalent	Professional Medical Products, Inc.
K820111	SIEMENS SIRESKOP 4	Feb 18, 1982	Substantially Equivalent	Siemens Corp.
K812791	PORTABLE MEDICAL TABLE	Nov 24, 1981	Substantially Equivalent	Richard D. Spradlin
K811969	DUAL PEDESTAL TABLE	Aug 13, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K811196	ALLMEC 90/15	Jun 09, 1981	Substantially Equivalent	Tecnomed, Inc.
K803120	TILTING IMAGING TABLE #846T	Jan 22, 1981	Substantially Equivalent	Quinton, Inc.
K790783	KOORDINAT 3D	May 07, 1979	Substantially Equivalent	Siemens Corp.
K790743	COORDINATUS, HORIZONTAL RADIOGRAPHOC	Apr 23, 1979	Substantially Equivalent	Pausch Corp.
K790692	TELEVIX	Apr 23, 1979	Substantially Equivalent	General Electrical Espanola, S.A.
K790536	CLEARVIEW	Mar 28, 1979	Substantially Equivalent	Hipoint Research, Inc.
K781992	KOORDINAT ANGIO	Dec 07, 1978	Substantially Equivalent	Siemens Corp.