Duns Number:600049276
Device Description: The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of th 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 remoteviewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
Catalog Number
-
Brand Name
EVA System
Version/Model Number
EVA 3 Plus/EVA 3.1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161871,K161871,K161871,K161871,K161871
Product Code
HEX
Product Code Name
Colposcope (And Colpomicroscope)
Public Device Record Key
acc396db-c18e-4b4b-a790-c00e0e2a4b66
Public Version Date
December 21, 2018
Public Version Number
1
DI Record Publish Date
November 20, 2018
Package DI Number
17290016976547
Quantity per Package
1
Contains DI Package
17290016976028
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Universal
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |