FDA.reportPublic FDA data

510(k) K904044

Device
Tf-63sa
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
510(k) number
K904044
Product code
KPW
Decision
Substantially Equivalent (SESE)
Decision date
1990-11-29
Date received
1990-09-04
Regulation
892.1610
Classification name
Device, Beam Limiting, X-Ray, Diagnostic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TIMOTHY CAPEHART
Address
2441 Michelle Dr. P.O. Box 2068 Tustin CA US 92781 92781

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KPW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093596LUMOS, MODEL R 72BLumos, Inc.2010-01-12
K062788COLLIMATOR, MODEL M-38Umi International2006-12-28
K030487R 72Ralco S.R.L.2003-08-01
K954310BLA-800AToshiba Medical Systems1995-10-18
K946320R 302Ralco S.R.L.1995-05-11
K914184P2020-8-0 BEAM-LIMITING DEVICEPrecise Optics1991-11-27
K904587DENSICOMP 250L. Keroack Co.1991-01-24
K904489EUREKA EXTENSION CYLINDERSEureka X-Ray Tube Corp.1990-10-15
K820306RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHICTecnomed, Inc.1982-03-05
K820305RALCO COLLIMATORS, MANUAL RADIOGRAPHICTecnomed, Inc.1982-03-04
K820119PODIOSCOPE BY ARROWArrow X-Ray Corp.1982-02-18
K811450ALUMINUM FILTRATION SYSTEMWedge Filtration System1981-07-02
K791504AUTOMATIC POSITIVE BEAM COLLIMATORDial-X Instruments, Inc.1979-09-07
K781984COLLIMATOR, HEART CONTOURSiemens Corp.1978-12-04
K770335COLLIMATOR, AUTOMATICLitton Medical Systems1977-02-28