Collimator, Automatic, Radiographic

Product Code: IZW

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]

Code of Federal Regulations: 892.1610


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as IZW

5349Collimator, Automatic, RadiographicDiagnostic X-ray Beam-limiting Device.

Total Product Life Cycle (TPLC) Devices

5349Collimator, Automatic, RadiographicDiagnostic X-ray Beam-limiting Device.

FDA Consensus Standards

Collimator, Automatic, Radiographic [37593]21 CFR §892.1610 🔎
Collimator, Automatic, Radiographic [37630]21 CFR §892.1610 🔎

Pre-market Notifications for IZW

K101039SHIMADZU COLLIMATOR R-300SHIMADZU CORP.
K093572R650 QDASM COLLIMATOROMEGA MEDICAL IMAGING, INC.
K091517RALCO, MODEL R225 ACSRALCO S.R.L.
K090578SHIMADZU COLLIMATOR R-30HSHIMADZU CORP.
K083029MODEL R605DASM AUTOMATIC X-RAY COLLIMATORRALCO S.R.L.
K073124COLLIMARE COLLIMATOR FAMILYCOLLIMARE, LLC
K072780MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATORRALCO S.R.L.
K050092R605 FACS COLLIMETEROMEGA MEDICAL IMAGING, INC.
K031597DUNLEE FORMAT COLLIMATOR FAMILYPHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K990423PHILIPS NICOL COLLIMATOR FAMILYPHILIPS MEDICAL SYSTEMS, INC.
K984414XRE COLLIMATOR WITH SPECTRAL FILTERTREX MEDICAL CORP.
K960998XRE COLLIMATORXRE CORP.
K920725COLLIMATOR F-20SHIMADZU MEDICAL SYSTEMS
K920733STEREO COLLIMATOR RF-T SERIESSHIMADZU MEDICAL SYSTEMS
K911127COLLIMASTER-90VARIAN ASSOC., INC.

Global Unique Device Identification Database

00884838081093Collimator, automatic, radiographic
00871875500467Collimator, Automatic, Radiographic
04540217051939Collimator, Automatic, Radiographic
04540217051908Collimator, Automatic, Radiographic
60889976573778Collimator, automatic, radiographic
60889976568811Collimator, automatic, radiographic
08718755000795Collimator, Automatic, Radiographic
08718755001419Collimator, Automatic, Radiographic
08718755001426Collimator, Automatic, Radiographic
08718755001402Collimator, Automatic, Radiographic
08718755001396Collimator, Automatic, Radiographic
08718755000887Collimator, Automatic, Radiographic
08718755000870Collimator, Automatic, Radiographic
08718755000863Collimator, Automatic, Radiographic
08718755000856Collimator, Automatic, Radiographic

Maude Adverse Events

MIDMARK/PROGENYQUANTUM MEDICAL IMAGING, LLC.2014-09-17
EUREKA COLLIMATORMIDMARK CORPORATION2011-06-23
EUREKA COLLIMATORMIDMARK CORPORATION2010-01-22
LINGAR COLLIMATORPROGENY, INC2007-07-02
ULTRANET SGE MEDICAL SYSTEMS S.C.S.2007-05-30
RALCO COLLIMATOR IN XPLORER 1590 SYSTEMRALCO INC2006-11-27
LINEAR IIIPROGENY, INC.2002-03-19
EUREKA LINEAR IIIPROGENY, INC.2000-11-08
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