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LMB — Device, Digital Image Storage, Radiological Class I

FDA Device Classification

Classification Details

Product Code
LMB
Device Class
Class I
Regulation Number
892.2010
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K992131samsung sds coSAMSUNG RAYPAX LONG TERM ARCHIVESeptember 13, 1999
K984405intracomECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000February 8, 1999
K983447sectra-imtecWISE (II) IMAGE MANAGEMENT SYSTEMOctober 29, 1998
K980243parameter developmentsPARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)April 3, 1998
K973463o techOLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVEDecember 2, 1997
K973413i.s.g. technologiesID. STORE (RELEASE 2.0)November 25, 1997
K972380eastman kodakKODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)September 11, 1997
K971848tdk electronics corporation of americaTDK MEDICAL GRADE CD-RAugust 15, 1997
K971451o techWISE IMAGE MANAGEMENT SYSTEMJune 26, 1997
K963936biosoundACCESSPOINT, MED E-MAIL, DICOM READERMarch 31, 1997
K964803network conceptsUNIVISION ECHOCARDIOLOGY SYSTEMFebruary 11, 1997
K964274comviewWRITESTAR, AND VIEWSTARJanuary 10, 1997
K963395sectra-imtecIMAGESERVER 2000 PICTURE ARCHIVING SYSTEMOctober 25, 1996
K961680sony medical systemsSONY DKR-700 DIGITAL STILL RECORDERJuly 3, 1996
K961160base ten systemsUPACS VERSION 1.7June 11, 1996
K960981kodak health imaging systemsKODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARYJune 7, 1996
K960941base ten systemsUPACSJune 3, 1996
K951942insight systemsLAST IMAGE HOLDApril 8, 1996
K955237tauTIGERSCAN/TIGERVIEWApril 4, 1996
K960326fujifilm medical system u.s.aFCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEMMarch 7, 1996