FDA 510(k) Premarket Notification K024012: OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM

Submission Details & Decision

Normalized public record details for 510(k) notification K024012.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K024012

Applicant / Sponsor

Ge Oec Medical Systems

Device Name

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM

Product Code

JAA

Decision Date

2003-03-20

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Radiology (RA)

Clearance Type

Traditional

Third Party Flag

Date Received

2002-12-04

Related Establishments / Registrations

CANON INC. Registration: 1000181430 View Registration
NRT X-RAY A/S Registration: 1000188474 View Registration
DMX IMAGING, LLC Registration: 1000221974 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
ADVANCE MEDICAL DESIGNS, INC. Registration: 1037885 View Registration
DORNIER MEDTECH AMERICA, INC. Registration: 1037955 View Registration
PREFERRED MEDICAL PRODUCTS, LLC Registration: 1038913 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
OMEGA MEDICAL IMAGING, LLC Registration: 1052701 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
REMINGTON MEDICAL, INC. Registration: 1056553 View Registration
STORZ MEDICAL AMERICA, INC. Registration: 1061158 View Registration
RADIOLOGY INFORMATION SYSTEMS, INC. Registration: 1125622 View Registration
UMI INTL. Registration: 1225677 View Registration
Varex Imaging Corporation Registration: 1717855 View Registration
GE OEC MEDICAL SYSTEMS, INC Registration: 1720753 View Registration
MEDTRONIC NAVIGATION, INC. Registration: 1723170 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
BIOSEAL Registration: 2027062 View Registration
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DEROYAL INDUSTRIES, INC. Registration: 2320762 View Registration
STRYKER ENDOSCOPY Registration: 2936485 View Registration
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FUJIFILM CORPORATION Registration: 3001722928 View Registration
Siemens Healthineers AG Registration: 3002466018 View Registration
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SHIMANE SHIMADZU CORPORATION Registration: 3003927316 View Registration
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CANON COMPONENTS, INC. Registration: 3004026651 View Registration
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