Blackford Platform

GUDID 05060570830037

Blackford Platform v2.1.x, supplied with Blackford Registration Application (part of the Blackford Product Family)

BLACKFORD ANALYSIS LIMITED

Radiology picture archiving and communication system application software
Primary Device ID05060570830037
NIH Device Record Key81083dda-ef27-49f5-b4b7-047a8045268a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlackford Platform
Version Model Number2.1.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

Device Identifiers

Device Issuing AgencyDevice ID
GS105060570830037 [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 Date2019-03-04
Device Publish Date2019-01-31

On-Brand Devices [Blackford Platform]

05060570830037Blackford Platform v2.1.x, supplied with Blackford Registration Application (part of the Blackfo
05060570830006Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackfo
05060570830068Blackford Platform v2.2.x, supplied with Blackford Smart Localizer (part of the Blackford Produc
05060570830099Blackford Platform v2.3.x, supplied with Blackford Smart Localizer (part of the Blackford Produc
05060570830112Blackford Platform v2.4.x, supplied with Blackford Smart Localizer (part of the Blackford Produc
05060570830150Blackford Platform v3.0.x, supplied with Blackford Smart Localizer (part of the Blackford Produc

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