Beacon
4MP Integrated Dual-screen Display
5manufacturers in China registered for this device type
33catalogue numbers in this listing
13510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Qingdao Hisense Medical Equipment Co., Ltd. | Qingdao | Shandong | Manufacturer | 5 |
| LG Electronics Nanjing New Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Shenzhen Beacon Display Technology Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 2 |
Record
| Listed by | Shenzhen Beacon Display Technology Co., Ltd., China |
|---|---|
| FDA product code | PGY |
| Device type | Display, Diagnostic Radiology |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K182291 |
| Record published | 2020-12-02 |
| Record revised | 2023-05-08 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G23S+ | In distribution | |
| C61W+ | In distribution | |
| CB5MP | In distribution | |
| C22S+ | In distribution | |
| G32S+ | In distribution | |
| C516S | In distribution | |
| C53SP+ | In distribution | |
| G510S | In distribution | |
| C81W+ | In distribution | |
| G53S+ | In distribution | |
| G316S | In distribution | |
| C316S | In distribution | |
| G22S+ | In distribution | |
| C44W+ | In distribution | |
| G310S | In distribution | |
| C82W+ | In distribution | |
| C310S | In distribution | |
| C822W | In distribution | |
| C53S+ | In distribution | |
| C83W+ | In distribution | |
| G516S | In distribution | |
| G32SP+ | In distribution | |
| G22SP+ | In distribution | |
| C85W+ | In distribution | |
| C1216W | In distribution | |
| G23SP+ | In distribution | |
| C32SP+ | In distribution | |
| G53SP+ | In distribution | |
| C32S+ | In distribution | |
| C616W | In distribution | |
| C510S | In distribution | |
| MB5MP | In distribution | |
| C22SP+ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadiForce® | Eizo Corporation | 108 |
| JVC | JVC Kenwood Corporation | 20 |
| Nio Color 3MP | Barco, Inc | 18 |
| Jusha | Nanjing Jusha Display Technology Co., Ltd. | 16 |
| Nio Color 2MP | Barco, Inc | 14 |
| Totoku | JVC Kenwood Corporation | 11 |
| LG | LG Electronics Inc. | 11 |
| Nio 5.8MP Gray | Barco, Inc | 8 |
| Hisense | Qingdao Hisense Medical Equipment Co., Ltd. | 7 |
| Coronis Fusion 4MP | Barco, Inc | 7 |
| Coronis Fusion 6MP | Barco, Inc | 6 |
| Coronis 5MP | Barco, Inc | 6 |
Showing 12 of 40. All products under Display, Diagnostic Radiology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252780 | 2025-12-19 |
| K253242 | 2025-10-29 |
| K243031 | 2024-10-25 |
| K240310 | 2024-03-29 |
| K233897 | 2024-02-06 |
| K231026 | 2023-08-18 |
| K202374 | 2020-10-19 |
| K201211 | 2020-09-03 |
| K201599 | 2020-07-02 |
| K200864 | 2020-05-19 |
| K182291 | 2018-11-20 |
| K172815 | 2017-10-27 |
| K162527 | 2016-09-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.