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510(k) K883974

Device
TANGENT II
Applicant
FISCHER IMAGING CORP.
510(k) number
K883974
Product code
IZZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-10-20
Date received
1988-09-20
Regulation
892.1980
Classification name
Table, Radiographic, Non-tilting, Powered
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICHARD S LUCAS
Address
12300 N. Grant St. Denver CO US 80241 80241

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IZZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971452MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLESiemens Medical Solutions USA, Inc.1997-05-14
K952701MED-TRON SPECT IMAGING TABLEMed-Tron Products, Inc.1995-07-06
K951315CATHETERIZATION TABLE KS-60Shimadzu Medical Systems1995-05-11
K951053ANGIOREX CAT-350BToshiba America Medical Systems, In.C1995-04-06
K943926RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLEPhilips Medical Systems (Cleveland), Inc.1994-11-28
K930273ALPHARaymax Medical Corp.1993-07-13
K924444B-4 FOUR-WAY RADIOGRAPHIC TABLEControl-X, Inc.1993-02-05
K925174SHIMADZU RADIOGRAPHIC TABLE BK-100Shimadzu Medical Systems1992-11-27
K921501DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004Biodan Medical Systems, Ltd.1992-05-15
K920732CATHERIZATION KS-50Shimadzu Medical Systems1992-04-16
K915413CAT-250BToshiba America Medical Systems, In.C1991-12-19
K912516CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111Continental X-Ray Corp.1991-11-19
K912474CLASSIC 4-WAY ELEVATING TABLEContinental X-Ray Corp.1991-09-16
K903921MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLEImt America, Inc.1990-12-04
K896665EXT-600 TABLE, RADIOGRAPHIC, ELEVATINGRms Div.1990-01-22

Legacy Summary#

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FDA Review#

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