Collimator, Manual, Radiographic

Product Code: IZX

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 IZX

5350Collimator, Manual, RadiographicDiagnostic X-ray Beam-limiting Device.

Total Product Life Cycle (TPLC) Devices

5350Collimator, Manual, RadiographicDiagnostic X-ray Beam-limiting Device.

FDA Consensus Standards

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

Pre-market Notifications for IZX

K110856RALCORALCO S.R.L.
K101036SHIMADZU COLLIMATOR R-20JSHIMADZU CORP.
K042840SHIMADZU COLLIMATOR R-20JSHIMADZU CORP.
K031771SHIMADZU COLLIMATOR R-30HSHIMADZU CORP.
K981267FACTS MONOBLOCKDYNARAD CORP.
K974240LIGHTLINE-MWUESTEC MEDICAL, INC.
K972966AXT 150M MANUAL COLLIMATOR (AXT 150M)APPLIED X-RAY TECHNOLOGIES, INC.
K932134RINN UNIVERSAL COLLIMATORRINN CORP.
K912180MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CMINSTRUMENTARIUM IMAGING, INC.
K900007R-100-ET MANUAL COLLIMATORADVANTECH
K896486R-150-ET COLLIMATORADVANTECH
K874687COLLI-MATETM MODEL NO. B800SUMMIT INDUSTRIES, INC.
K861941COLLIMATOR MODEL A280BLMD & MODEL A280BLMPD&R X-RAY PRODUCTS, INC.
K840678UXM MODEL 8188UNIVERSAL X-RAY
K801168COLLIMAX X-RAY COLLIMATOR # R-182ITO X-RAY CORP.

Global Unique Device Identification Database

00871875500412Collimator, Manual, Radiographic
00871855000405Collimator, Manual, Radiographic
00862005000368Collimator, Manual, Radiographic
00862005000351Collimator, Manual, Radiographic
00862005000344Collimator, Manual, Radiographic
00862005000337Collimator, Manual, Radiographic
00862005000320Collimator, Manual, Radiographic
00862005000313Collimator, Manual, Radiographic
00862005000306Collimator, Manual, Radiographic
00850077007194Collimator, Manual, Radiographic
00850077007187Collimator, Manual, Radiographic
00850077007156Collimator, Manual, Radiographic
00850077007149Collimator, Manual, Radiographic
00850077007132Collimator, Manual, Radiographic
00850077007064Collimator, Manual, Radiographic

Maude Adverse Events

SUMMIT SWIVEL COLLIMATORSUMMIT INDUSTRIES, LLC2014-07-17
SUMMIT SWIVEL COLLIMATORSUMMIT INDUSTRIES, INC.2007-06-26
NM MILLENNIUM MPR COLLIMATORGE MEDICAL SYSTEMS, F.I. HAIFA2004-12-30
EUREKA LINEAR IIIPPROGENY, INC.1998-05-21
PROGENCY, INCPROGENY, INC.1998-04-23
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