FDA.reportPublic FDA data

Blackford Accept Reject Tool

Primary DI
05060570830334
Brand
Blackford Accept Reject Tool
Company
BLACKFORD ANALYSIS LIMITED
Model
1.x
Device description
The Blackford Accept Reject Tool™ is a software application that is intended to be used by qualified healthcare professionals to review and then Accept or Reject Results from Clinical Applications that operate on digital clinical images. The Blackford Accept Reject Tool™ is primarily used to display and view Instances or Series associated with a Study, and to Accept or Reject the Findings generated by Clinical Applications prior to transferring that clinical data to a downstream PACS or Reporting System.
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060570830334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060570830334050605708303345060570830334

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
216768293
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060570830150Blackford Platform3.0.x2023-03-28
05060570830112Blackford Platform2.4.x2022-11-15
05060570830099Blackford Platform2.3.x2021-04-14
05060570830105Blackford Smart Localizer1.4.x2021-04-14
05060570830068Blackford Platform2.2.x2020-05-18
05060570830075Blackford Smart Localizer1.3.x2020-05-18
05060570830082Blackford Dashboard1.2.x2020-05-18
05060570830006Blackford Platform2.0.x2018-04-27
05060570830013Blackford Registration Application1.2.x2018-04-27
05060570830037Blackford Platform2.1.x2019-01-31
05060570830044Blackford Registration Application1.3.x2019-01-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415334059139BarcoBarco NVLMD2026-09-21
05415334059924BarcoBarco NVLMD2026-09-21
05415334059931BarcoBarco NVLMD2026-09-21
04056481144616Quip EyeBrainlab SELMD2026-08-25
04056481145804Brainlab Origin ORBrainlab SELMD2026-08-21
00850054590183interWORKSAvreo IncLMD2026-08-03
00850054590176interWORKSAvreo IncLMD2026-07-29
04056481147099Buzz O.R. ComputeBrainlab SELMD2026-07-09
00850054590169interWORKSAvreo IncLMD2026-07-08
B214CORELABV100CORELabmedimaps group SALMD2026-06-29
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-06-05
30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-05-12
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-01-21
00850054590152interWORKSAvreo IncLMD2025-12-08
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21