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510(k) K953514

Device
COURIER II
Applicant
GAMMEX, INC.
510(k) number
K953514
Product code
LMD  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-07
Date received
1995-07-26
Regulation
892.2020
Classification name
System, Digital Image Communications, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS A DEMKE
Address
2500 W. Beltline Hwy. P.O. Box 620327 Middleton WI US 53562 53562

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LMD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.2000-05-26
K992698STENTOR, PAGEVIEWStentor, Inc.1999-10-25
K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.1999-10-13
K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.1999-09-29
K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.1999-07-06
K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.1999-01-12
K974707IMAGEQUESTVisual Med, Inc.1998-07-31
K981053KODAK DIGITAL SCIENCES (KDS) IMAGE VIEWEastman Kodak Company1998-06-18
K980918JPACSPhilips Medical Systems (Cleveland), Inc.1998-06-03
K974882DOWNSCAN LTMerlin Engineering Works, Inc.1998-05-22
K980684VR NETSERVEI.S.G. Technologies, Inc.1998-05-06
K980541BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAYBarco NV Display Systems1998-04-09
K980241NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARENetco Communications Corp.1998-03-17
K980220IISYS PACS SYSTEMSterling Diagnostic Imaging, Inc.1998-02-13
K974130VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWAREDejarnette Research Systems1998-01-29

Legacy Summary#

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FDA Review#

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