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510(k) K000159

Device
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
Applicant
AGFA CORP.
510(k) number
K000159
Product code
IXK  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-16
Date received
2000-01-19
Regulation
892.1630
Classification name
System, Imaging, X-ray, Electrostatic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TIMOTHY W CAPEHART
Address
10 S. Academy St. Greenville SC US 29601 29601

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IXK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093640DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRAElectron Jsco.2011-04-29
K072766PVMED DDR 2520 DIGITAL IMAGING SYSTEMPortavision Medical2007-12-11
K042779RADIOTHERAPY SOLUTION BASED ON CRAgfa Corp.2004-10-21
K032654PORT CASSETTEOrex Computed Radiography, Ltd.2003-10-09
K003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31Canon USA, Inc.2002-01-02
K942561FUJI FCR IMAGE PROCESSING UNIT IP-U515Fujifilm Medical System U.S.A., Inc.1994-12-23
K934949DIGORAOrion Corporation Soredex1994-02-10
K931002FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONSFujifilm Medical System U.S.A., Inc.1993-06-08
K923990FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGEFujifilm Medical System U.S.A., Inc.1992-12-17
K924459DIGISCAN 2Siemens Medical Solutions USA, Inc.1992-12-17
K924012FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGEFujifilm Medical System U.S.A., Inc.1992-10-16
K853459XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEMXerox Medical Systems1985-10-30
K761022XERORADIOGRAPHY 125 SYSTEM - MODIFIEDXeroradiography1976-11-24

Legacy Summary#

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FDA Review#

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