510(k) Report

FDA applicant

Dicom Grid Inc Dba Ambra Health

New York, NY2 decisions2020–20232 recalls

FDA records 2 decisions for Dicom Grid Inc Dba Ambra Health (New York, NY) from 2020 to 2023: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Dicom Grid Dba Ambra Health”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Dicom Grid Inc Dba Ambra Health’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12023: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 12025: 1
2020high 1 (2022) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Dicom Grid Inc Dba Ambra Health by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health · 20202cite it

What has FDA decided for it lately?

  • K231360Ambra PACSDicom Grid Dba Ambra Health · 20231 recall
  • K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health · 20201 recall

The one decision as Dicom Grid Inc Dba Ambra Health →The one decision as Dicom Grid Dba Ambra Health →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K231360Intelerad InteleShare software, with ProViewer componentNov 18, 2025Class II
  • K202335Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool…Jun 23, 2022Class II

Other applicant names beginning “Dicom”

FDA records each applicant name separately; these may or may not be the same firm.

Dicom Grid, Inc. 1