Product Code: KPX FDA class 2 21 CFR 892.1860

Changer, Radiographic Film/Cassette

Radiology

This device is a radiographic film and cassette changer, a mechanical system used in radiology departments to automatically advance and position imaging film or cassettes during rapid-sequence radiographic examinations such as angiography. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPX, regulated under 21 CFR 892.1860 within the Radiology specialty. No special flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: KPX
Device Class: FDA class 2
Regulation Number: 892.1860
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 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K945635	TRANS X-1000	Feb 01, 1995	Substantially Equivalent	CANON U.S.A., INC.
K935157	ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES	Aug 09, 1994	Substantially Equivalent	REGULATORY CONSULTANTS TO THE MEDICAL DEVICE INDUS
K934850	NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS	Nov 22, 1993	Substantially Equivalent	VICTOREEN, INC.
K933035	BCM-600TX	Oct 08, 1993	Substantially Equivalent	B C MEDICAL LTD.
K925598	BUCKYMATIC AUTOMATIC CHEST FILM CHANGER	Feb 01, 1993	Substantially Equivalent	ACOMA MEDICAL IMAGING, INC.
K924423	MWX-7440 HIGH SPEED BUCKY	Jan 15, 1993	Substantially Equivalent	MIDWEST X-RAY EQUIPMENT CO.
K925169	SHIMADZU RADIOGRAPJHIC STAND BR-100	Dec 03, 1992	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K920196	OX-600	Oct 14, 1992	Substantially Equivalent	STARDARD X-RAY SALES CO.
K922483	DU PONT COMPACT DAYLIGHT SYSTEM 2000	Sep 11, 1992	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K905789	FRANKLIN 9000 WALL STAND	May 20, 1991	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K902761	AUTOMATIC CASSETTE LOADER	Oct 09, 1990	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K903576	PUCK 90M	Sep 04, 1990	Substantially Equivalent	ELEMA-SCHONANDER, INC.
K870048	ADDITIONAL MODEL TO CANON UNIVERSAL STAND	Jan 12, 1987	Substantially Equivalent	CANON U.S.A., INC.
K862575	UNIVERSAL STAND FOR FILM CHANGER	Jul 14, 1986	Substantially Equivalent	CANON U.S.A., INC.
K853928	UNIVERSAL STAND FOR FILM CHANGER	Oct 28, 1985	Substantially Equivalent	CANON U.S.A., INC.
K851067	CANON X-RAY FILM CHANGER CFC-U1	May 21, 1985	Substantially Equivalent	CANON U.S.A., INC.
K842911	PUCK U & UD CUTFILM CHANGERS	Aug 21, 1984	Substantially Equivalent	ELEMA-SCHONANDER, INC.
K820117	AUTOMATIC TRAY (ACT I & ACT II	Feb 18, 1982	Substantially Equivalent	BURBURY & CUTTER IND., INC.
K812024	XEROX 128 CASSETTE CHANGER	Aug 13, 1981	Substantially Equivalent	XEROX MEDICAL SYSTEMS
K811967	CP-625 SEE-THRU FILM CHANGER	Aug 13, 1981	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K801950	BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO	Oct 03, 1980	Substantially Equivalent	B C MEDICAL LTD.
K800751	RADX VENT-AL MECHANICAL RESPORATOR	May 08, 1980	Substantially Equivalent	RADX CORP.
K792068	MEMCO 300 FILM CHANGER	Nov 16, 1979	Substantially Equivalent	MEMCO, INC.
K791811	SPECTRUM AUTOMATIC CHEST UNIT MODEL C	Oct 26, 1979	Substantially Equivalent	SPECTRUM X-RAY CORP.
K770836	ULTIMAT L4 X L4, LIEBEL-FLARSHEIM	May 26, 1977	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K760279	X-RAY FILM, CONVEY OR SYSTEM	Aug 13, 1976	Substantially Equivalent	MALLINCKRODT GROUP, INC.