Blackford Smart Localizer

GUDID 05060570830075

Blackford Smart Localizer v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application

BLACKFORD ANALYSIS LIMITED

Radiology PACS software
Primary Device ID05060570830075
NIH Device Record Key9922c618-8383-4f7b-bd83-bc61086fabce
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlackford Smart Localizer
Version Model Number1.3.x
Company DUNS216768293
Company NameBLACKFORD ANALYSIS LIMITED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com
Phone+4401316688228
Emailsupport@blackfordanalysis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060570830075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-26
Device Publish Date2020-05-18

On-Brand Devices [Blackford Smart Localizer]

05060570830075Blackford Smart Localizer v1.3.x, supplied with Blackford Platform (part of the Blackford Produc
05060570830105Blackford Smart Localizer v1.4.x, supplied with Blackford Platform (part of the Blackford Produc

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