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510(k) K896486

Device
R-150-ET COLLIMATOR
Applicant
ADVANTECH
510(k) number
K896486
Product code
IZX  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-23
Date received
1989-11-13
Regulation
892.1610
Classification name
Collimator, Manual, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHARLES E MORELAND
Address
16 Lawrence St. Wakefield MA US 01880 01880

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IZX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110856RALCORalco S.R.L.2011-08-10
K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.2010-08-26
K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.2004-12-03
K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.2003-08-21
K981267FACTS MONOBLOCKDynarad Corp.1998-05-06
K974240LIGHTLINE-MWuestec Medical, Inc.1997-12-22
K972966AXT 150M MANUAL COLLIMATOR (AXT 150M)Applied X-Ray Technologies, Inc.1997-08-21
K932134RINN UNIVERSAL COLLIMATORRinn Corp.1993-07-26
K912180MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CMInstrumentarium Imaging, Inc.1991-10-21
K900007R-100-ET MANUAL COLLIMATORAdvantech1990-02-06
K874687COLLI-MATETM MODEL NO. B800Summit Industries, Inc.1987-12-30
K861941COLLIMATOR MODEL A280BLMD & MODEL A280BLMPD&R X-Ray Products, Inc.1986-07-25
K840678UXM MODEL 8188Universal X-Ray1984-03-16
K801168COLLIMAX X-RAY COLLIMATOR # R-182Ito X-Ray Corp.1980-07-08
K780736CT 5221 DOSE REDUCING COLLIMATORSEmi Medical, Inc.1978-06-02

Legacy Summary#

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FDA Review#

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