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IWZ — Film, Radiographic Class I

FDA Device Classification

FDA product code IWZ covers "Film, Radiographic", a Class I medical device regulated under 21 CFR 892.1840. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IWZ
Device Class
Class I
Regulation Number
892.1840
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K970154Eastman KodakKODAK EKTASIAN HG FILM (EHG-15)Apr 4, 1997
K954200VoxelVOXGRAMSep 29, 1995
K9316043M Health Care3M MEDICAL DIAGNOSTIC VIDEOCASSETTEJul 21, 1993
K9316053M Health Care3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTEJul 20, 1993
K920539Burkhart Roentgen IntlORWO X-RAY FILMJun 30, 1992
K884827Eastman KodakKODAK DENTAL BARRIER PACJan 30, 1989
K862944Eastman KodakKODAK CFT FILM SO-141Aug 12, 1986
K862415Parexel IntlTYPE 633 COMPUTED RADIOGRAPHY (CR) FILMJul 1, 1986
K860797India-America TradingMEDICAL X-RAY FILMMar 13, 1986
K844554Belmont EquipmentBELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOGFeb 21, 1985
K840806Fr Medical/Fr ChemicalsFR MEDICAL X-RAY FILMApr 24, 1984
K840698Powers ChemcoPOWERMAT VRP-1 X-RAY IMAGINGMar 16, 1984
K834613Cea AmericaWILCOR-XR RP MEDICAL FILMMar 5, 1984
K834614Cea AmericaWILCOR-XR RP-L MEDICAL FILMMar 5, 1984
K834612Cea AmericaWILCOR-XR RP-OG MEDICAL FILMFeb 27, 1984
K834611Cea AmericaSINGUL-XR RP NON SCREEN MED. FILMFeb 21, 1984
K833234Eastman KodakKODAK T-MAT L FILM SO-387Oct 28, 1983
K832504E.I. Dupont De Nemours And CoCRONEX LO-DOSE MAMMOGRAPHYSep 12, 1983
K813005Eastman KodakKODAK CINEFLUOROGRAPHIC FILM SO-274Nov 24, 1981
K811352PolaroidPOLAROID TPX RADIOGRAPHIC FILMJun 18, 1981

FDA data resources