Jusha
16 catalogue numbers from C620G, listed by Nanjing Jusha Display Technology Co., Ltd., China, under Display, Diagnostic Radiology. 5 manufacturers in China are registered for 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 | Nanjing Jusha Display Technology Co., Ltd., China |
|---|---|
| FDA product code | PGY |
| Device type | Display, Diagnostic Radiology |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| Record published | 2024-01-24 |
| Record revised | 2024-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C620G | In distribution | |
| M550G | In distribution | |
| C510G | In distribution | |
| C270G | In distribution | |
| JUSHA-CP610 | In distribution | |
| M260G | In distribution | |
| R191 | In distribution | |
| C660G | In distribution | |
| C810G | In distribution | |
| C350G | In distribution | |
| R190 | In distribution | |
| JUSHA-M53 | In distribution | |
| C1210G | In distribution | |
| M350G | In distribution | |
| C630G | In distribution | |
| CP620G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadiForce® | Eizo Corporation | 108 |
| Beacon | Shenzhen Beacon Display Technology Co., Ltd. | 33 |
| JVC | JVC Kenwood Corporation | 20 |
| Nio Color 3MP | Barco, Inc | 18 |
| 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 |
|---|---|
| K230728 | 2023-06-09 |
| K231170 | 2023-06-07 |
| K230723 | 2023-05-18 |
| K230643 | 2023-05-01 |
| K222121 | 2022-09-19 |
| K212231 | 2022-03-25 |
| K200742 | 2020-07-24 |
| K190848 | 2019-05-14 |
| K183496 | 2019-04-08 |
| K183494 | 2019-04-05 |
| K183492 | 2019-03-13 |
| K183498 | 2019-02-05 |
| K183499 | 2019-02-04 |
| K183497 | 2019-01-15 |
| K151861 | 2015-09-10 |
| K151972 | 2015-09-10 |
| K151238 | 2015-06-12 |
| K150842 | 2015-04-28 |
| K150746 | 2015-04-14 |
| K141684 | 2014-08-01 |
| K141690 | 2014-08-01 |
| K141679 | 2014-08-01 |
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.