The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and…
The VISUCAM Digital Fundus Camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye beeing examined under mydriatic and non-mydriatic conditions. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographiacally documented.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Chongqing (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Visucam 524 | Listed by | Carl Zeiss Meditec Inc, United States |
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-01-15 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 90 % RH; Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 95 % RH |
| Sizes | Weight 36 kg |
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.