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Koios DS

by Koios Medical, Inc. 2 variants

510(k) K212616

Koios DS is a Class II device made by Koios Medical, Inc., cleared under FDA 510(k) K212616 on 16 Dec 2021, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212616 Date16 Dec 2021ClearedStatusActive

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  • Withdrawn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
POK
Device class
Class II
Regulation
21 CFR Part 892.2060
Advisory committee
Radiology
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 K212616

1 device · 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 K212616
UDI-DISize and differences
Koios DS 3.x
Koios Medical, Inc.
3.x00860002545714 —On the market

Similar devices

Other devices filed under FDA product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Other devices from Koios Medical, Inc.

  • Koios DS (3.8)

    Class II

  • Koios Medical 2.x

    Class II

  • Koios DS 3.x

    Class II

  • Koios DS

    Class II

See all devices from Koios Medical, Inc. →