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Ambra ProViewer

by Dicom Grid Inc Dba Ambra Health

510(k) K202335

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202335 Date4 Sep 2020ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1818-2022 FDA Class II initiated 23 Jun 2022

    A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Dicom Grid Dba Ambra Health

  • Ambra PACS Open recall

    Class II