Data / Medical devices / United States / Double Black Imaging Corporation
Double Black Imaging Corporation: FDA-registered device maker in Louisville, CO, United States, 12 510(k) clearances
Double Black Imaging Corporation is registered with the FDA (registration 3008481104) in Louisville, CO, United States. It lists 3 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008481104
- Address
- 246 S Taylor Ave, Unit 300, Louisville, CO, United States, 80027
- Owner or operator
- Double Black Imaging Corp. (10060761)
- Roles
- Repackager or relabeler
- First device listed
- June 20, 2019
- Registered through
- 2026
- Brand names listed
- 21HQ513D, 21HQ613D, 31HN713D, 32HL512D, 32HQ713D, C1216W, C316S, C516S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Pathology Display | PZZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Display, Diagnostic Radiology | PGY | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2025 | K253242 | LCD Monitor (C1216W, C822W, C821W) | PGY | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. | accessdata.fda.gov |
| December 28, 2024 | K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | PZZ | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. | accessdata.fda.gov |
| October 25, 2024 | K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W | PGY | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. | accessdata.fda.gov |
| March 29, 2024 | K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | PGY | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. | accessdata.fda.gov |
| February 15, 2024 | K240130 | Medical Monitor (21HQ613D) | PGY | Substantially Equivalent | Lg Electronics.Inc | accessdata.fda.gov |
| February 6, 2024 | K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | PGY | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. | accessdata.fda.gov |
| August 18, 2023 | K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) | PGY | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. | accessdata.fda.gov |
| March 1, 2023 | K223423 | 32HQ713D | PGY | Substantially Equivalent | Lg Electronics.Inc | accessdata.fda.gov |
| December 3, 2021 | K212295 | 21HQ513D | PGY | Substantially Equivalent | Lg Electronics.Inc | accessdata.fda.gov |
| October 8, 2020 | K201777 | 31HN713D | PGY | Substantially Equivalent | Lg Electronics.Inc | accessdata.fda.gov |
| March 13, 2020 | K192925 | 32HL512D | PGY | Substantially Equivalent | Lg Electronics.Inc | accessdata.fda.gov |
| November 20, 2018 | K182291 | 6MP Color LCD Monitor (C61W+) | PGY | Substantially Equivalent | Shenzhen Beacon Display Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Display, Diagnostic Radiology
- All makers of System, Image Processing, Radiological
- All makers of Digital Pathology Display
Updated October 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.