Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011713193

FEI Number

3011713193

Entity Name

BLACKFORD ANALYSIS LTD

City/State/Country

EDINBURGH Midlothian, GB

Establishment Address

160 Causewayside, EDINBURGH Midlothian EH9 1PR, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Blackford Analysis (Owner Number: 10049370)

Owner / Operator Contact Address

160 Causewayside, Edinburgh, GB-MLN EH9 1PR, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142337

PMA Number

N/A

All Registered Proprietary Names

Blackford Accept Reject Tool Blackford Analysis Registration Product Family Blackford Product Family Blackford Platform & Blackford Smart Localizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2023-10-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-05-19

Official Correspondent

No official correspondent registered.

US Agent Details

Chris Meenan Business: Blackford Analysis Email: chris.meenan@blackfordanalysis.com Phone: (410) 4581018

Related Public Records

Same Entity

Blackford Analysis

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3006619220	Canon Medical Informatics A/S	Valby Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011713193. Last updated year: 2026. Please use registration number 3011713193 when referencing this establishment in official correspondence.