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Imagclear Mammography Review System

by Dba Systems, Inc. 510(k)

Active United States

510(k) K992467

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992467 Date10 Feb 2000ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LMA
Device Class
Class II
Regulation
21 CFR Part 892.2030
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Dba Systems, Inc.

  • Dfs-2100

    Class II