The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting…
The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor’s offices and remote and rural clinics.
Who Else Makes It
Concentrated in Guangxi (1), Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for EVA System | Listed by | Mobileodt, Ltd., Israel |
| FDA product code | HEX |
| Device type | Colposcope (And Colpomicroscope) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1630 |
| 510(k) | K161871 |
| Record published | 2017-05-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Universal, uk, eu, us |
| UDI direct marking | Exempt |
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.