2 catalogue numbers from Model III, listed by Carl Zeiss Meditec Inc, United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (4), Tianjin (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Callisto eye Panel PC | Listed by | Carl Zeiss Meditec Inc, United States |
| FDA product code | LMD |
| Device type | System, Digital Image Communications, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2020 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-06 |
| Record revised | 2020-08-20 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
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.