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ArteraAI Breast

by Artera, Inc.

510(k) K254115

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254115 Date4 May 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 10 Oct 2026.

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  • Withdrawn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
SHW
Device Class
Class II
Regulation
21 CFR Part 864.3755
Advisory Committee
Pathology
FDA Decision
SESE Substantially Equivalent

Other devices from Artera, Inc.

  • ArteraAI Prostate

    Class II