Hisense
The FDA summary identifies the Hisense LCD monitor models HMD2C21A, HMD4C27S and HMD6C30D. These monitors are intended for trained medical practitioners to view medical images and provide…
The FDA summary identifies the Hisense LCD monitor models HMD2C21A, HMD4C27S and HMD6C30D.
These monitors are intended for trained medical practitioners to view medical images and provide medical diagnostic functions.
Display Variants
The filing lists the HMD2C21A as a 2M color LCD diagnostic monitor with 1600 by 1200 resolution. It excludes mammography images for diagnosis, states DICOM compliance, and lists OSD menu, monitor-control and quality-control software.
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 | Qingdao Hisense Medical Equipment Co., Ltd., China |
|---|---|
| FDA product code | PGY |
| Device type | Display, Diagnostic Radiology |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K222208 |
| Record published | 2022-12-15 |
| Record revised | 2024-05-03 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HMD2C21A | In distribution | |
| HMD2G21S | In distribution | |
| HMD3G21S | In distribution | |
| HMD6C30D | In distribution | |
| HMD4C27S | In distribution | |
| HMD5G21S | In distribution | |
| HMD3C21S | 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 |
| 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 |
| 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 |
|---|---|
| K222208 | 2022-11-17 |
| K222132 | 2022-11-08 |
| K221567 | 2022-07-26 |
| K160347 | 2016-03-03 |
| K152030 | 2015-09-16 |
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.