Visionix
DIGITAL PHOTO UNIT SET with Dicom
7manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Right MFG. Co., Ltd., Japan |
|---|---|
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Manufacturer |
| 510(k) | K110129 |
| Record published | 2023-01-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Sizes | Width 350 mm; depth 387 mm; height 678.5 mm; weight 14 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MW50D | Width 350 mm | In distribution |
| MW50D | Width 350 mm | In distribution |
| MW50D | Width 350 mm | In distribution |
| MW50D | Width 350 mm | In distribution |
| MW50D | Width 350 mm | In distribution |
| MW50D | Width 350 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 30 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 24 |
| Marco | Takagi Seiko Co., Ltd. | 17 |
| Gilras | U.S. Ophthalmic, L.L.C. | 16 |
| Visionix | Luneau Technology Operations | 15 |
| LED Slit Lamp | Right MFG. Co., Ltd. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 12 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 12 |
| Inami | Inami & Co., Ltd. | 11 |
| Zoom Slit Lamp | Right MFG. Co., Ltd. | 8 |
| Slit Lamp BQ 900 | Haag-Streit AG | 8 |
| PolyLock Small Bone | Fusion Orthopedics, LLC | 7 |
Showing 12 of 168. All products under Biomicroscope, Slit-Lamp, Ac-Powered
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.