Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008481104

FEI Number

3008481104

Entity Name

Double Black Imaging Corporation

City/State/Country

Louisville, CO, US

Establishment Address

246 S Taylor Ave, Unit 300, Louisville, CO 80027, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Double Black Imaging Corp. (Owner Number: 10060761)

Owner / Operator Contact Address

4246 Golfview Drive, Jordan, MN 55352, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182291

PMA Number

N/A

All Registered Proprietary Names

C811W C811WT 31HN713D C822W C1216W C821W C316S C616W 32HL512D C316S C616W 32HQ713D 21HQ513D 21HQ613D C1216W C516S C61W+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PZZ	Digital Pathology Display	Pathology	Class 2	864.3700	2025-12-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-11-28
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2025-12-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-12-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-10-27
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-10-27
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-12-13
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-10-27
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-11-28
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-12-06
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2025-12-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2025-12-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2019-06-20

Official Correspondent

Joseph Lloyd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Double Black Imaging Corp.

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
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15
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

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)

Similar Registrations

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9613188	BARCO N.V.	KORTRIJK West-Vlaanderen, BE
3031232523	BEACON KOREA INC.	Seongnam-si Gyeonggi, KR
3013084615	D&T INC.	Yuseong-gu Daejeon, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008481104. Last updated year: 2026. Please use registration number 3008481104 when referencing this establishment in official correspondence.