Changer, Radiographic Film/cassette

Product Code: KPX

Radiology Medical Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1860


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as KPX

5373Changer, Radiographic Film/cassetteRadiographic Film/cassette Changer.

Total Product Life Cycle (TPLC) Devices

5373Changer, Radiographic Film/cassetteRadiographic Film/cassette Changer.

FDA Consensus Standards

Changer, Radiographic Film/Cassette [15724]21 CFR §892.1860 🔎

Pre-market Notifications for KPX

K945635TRANS X-1000CANON U.S.A., INC.
K935157ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBESREGULATORY CONSULTANTS TO THE MEDICAL DEVICE INDUS
K934850NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDSVICTOREEN, INC.
K933035BCM-600TXB C MEDICAL LTD.
K925598BUCKYMATIC AUTOMATIC CHEST FILM CHANGERACOMA MEDICAL IMAGING, INC.
K925169SHIMADZU RADIOGRAPJHIC STAND BR-100SHIMADZU MEDICAL SYSTEMS
K924423MWX-7440 HIGH SPEED BUCKYMIDWEST X-RAY EQUIPMENT CO.
K922483DU PONT COMPACT DAYLIGHT SYSTEM 2000E.I. DUPONT DE NEMOURS & CO., INC.
K920196OX-600STARDARD X-RAY SALES CO.
K905789FRANKLIN 9000 WALL STANDMALLINCKRODT GROUP, INC.
K902761AUTOMATIC CASSETTE LOADERMALLINCKRODT GROUP, INC.
K870048ADDITIONAL MODEL TO CANON UNIVERSAL STANDCANON U.S.A., INC.
K862575UNIVERSAL STAND FOR FILM CHANGERCANON U.S.A., INC.
K853928UNIVERSAL STAND FOR FILM CHANGERCANON U.S.A., INC.
K851067CANON X-RAY FILM CHANGER CFC-U1CANON U.S.A., INC.

Maude Adverse Events

AMBER-CUOLDELFT B.V.1997-05-30
AMBER-AUOLDELFT B.V.1997-05-30
PUCK FILM CHANGERSIEMENS MEDICAL SYSTEMS, INC.1996-05-02
PUCK FILM CHANGESIEMENS MEDICAL SYSTEMS1993-12-14
PUCKSIEMENS MEDICAL SYSTEMS1993-12-07
SCHONANDER-ELEMA AB FILM CHANGERSIEMENS MEDICAL SYSTEMS1993-08-18

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