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EVA (Enhanced Visual Assessment) System

by Mobileodt, Ltd.

510(k) K161871

EVA (Enhanced Visual Assessment) System is a medical device (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Mobileodt, Ltd., cleared under FDA 510(k) K161871 on 19 Dec 2016, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161871 Date19 Dec 2016ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HEX
FDA applicant
Mobileodt , Ltd.
Device class
Class II
Regulation
21 CFR Part 884.1630
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K161871

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K161871
UDI-DISize and differences
EVA System 2
Mobileodt, Ltd.
217290016976004 —On the market
EVA System 3.0
Mobileodt, Ltd.
3.017290016976011 —On the market
EVA System EVA 3 Plus/EVA 3.1
Mobileodt, Ltd.
EVA 3 Plus/EVA 3.117290016976028 —On the market

Similar devices

Other devices filed under FDA product code HEX (Colposcope (And Colpomicroscope)).

Other devices from Mobileodt, Ltd.