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510(k) K810590

Device
P.R.M. 80
Applicant
T.E.M. INSTRUMENTS LTD.
510(k) number
K810590
Product code
IZW  
Decision
Substantially Equivalent (SESE)
Decision date
1981-04-10
Date received
1981-03-04
Regulation
892.1610
Classification name
Collimator, Automatic, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101039SHIMADZU COLLIMATOR R-300Shimadzu Corp.2010-09-20
K093572R650 QDASM COLLIMATOROmega Medical Imaging, Inc.2010-02-03
K090578SHIMADZU COLLIMATOR R-30HShimadzu Corp.2009-11-06
K091517RALCO, MODEL R225 ACSRalco S.R.L.2009-07-14
K083029MODEL R605DASM AUTOMATIC X-RAY COLLIMATORRalco S.R.L.2008-12-05
K072780MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATORRalco S.R.L.2007-11-26
K073124COLLIMARE COLLIMATOR FAMILYCollimare, LLC2007-11-16
K050092R605 FACS COLLIMETEROmega Medical Imaging, Inc.2005-01-31
K031597DUNLEE FORMAT COLLIMATOR FAMILYPhilips Medical Systems North America Co.2003-07-21
K990423PHILIPS NICOL COLLIMATOR FAMILYPhilips Medical Systems, Inc.1999-03-15
K984414XRE COLLIMATOR WITH SPECTRAL FILTERTrex Medical Corp.1998-12-30
K960998XRE COLLIMATORXre Corp.1996-04-03
K951372PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)Philips Medical Systems, Inc.1995-05-04
K920725COLLIMATOR F-20Shimadzu Medical Systems1992-04-16
K920733STEREO COLLIMATOR RF-T SERIESShimadzu Medical Systems1992-04-16

Legacy Summary#

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FDA Review#

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