Programmer, Changer, Film/cassette, Radiographic

Product Code: IZP

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: 892.1870


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as IZP

5346Programmer, Changer, Film/cassette, RadiographicRadiographic Film/cassette Changer Programmer.

Total Product Life Cycle (TPLC) Devices

5346Programmer, Changer, Film/cassette, RadiographicRadiographic Film/cassette Changer Programmer.

Pre-market Notifications for IZP

K911888PHILIPS ANGIOPROPHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K904144PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEMMALLINCKRODT GROUP, INC.
K874451OMNIPLANE 200 FILM CHANGER SYSTEMMEDRAD, INC.
K841732LIEBEL-FLARSHEIM AFC 1000 X-RAY FILMSYBRON CORP.
K841649MAXIMAX - 4CGR MEDICAL CORP.

Maude Adverse Events

B.C.M.B.C. MEDICAL1994-01-10
OMNIPLANE FILM CHANGERMEDRAD1993-06-11
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