DICOM 6000

GUDID 15420045507449

Hologic, Inc.

Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID15420045507449
NIH Device Record Keyc447a592-8efb-442a-88f5-ab5bf9285fde
Commercial Distribution StatusIn Commercial Distribution
Brand NameDICOM 6000
Version Model NumberDICOM 6000
Company DUNS139534114
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045507449 [Primary]

FDA Product Code

LMDSystem, digital image communications, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2018-03-20

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