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Dicom Grid Dba Ambra Health

Also registered as Dicom Grid Inc Dba Ambra Health

Country not established

Devices
2
FDA recalls
11 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Dicom Grid Dba Ambra Health makes

Dicom Grid Dba Ambra Health manufactures the Ambra PACS, a picture archiving and communication system designed for storing, retrieving, and displaying medical imaging data in radiology workflows.

The Ambra PACS is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Ambra ProViewer Ref K202335 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ambra PACS Ref K231360 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Dicom Grid Dba Ambra Health, initiated on 2022-06-23. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2022

    • 23 Jun 2022 Z-1818-2022 Class II Ongoing 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. Distribution: Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY,…
      Full distribution text Domestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, DC, & PR.
      Submission number: K202335

Frequently asked questions

How many devices does Dicom Grid Dba Ambra Health have in the registry?

The registry currently lists 2 devices for Dicom Grid Dba Ambra Health. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dicom Grid Dba Ambra Health's devices?

Among its 2 most recently registered devices, Dicom Grid Dba Ambra Health has devices listed in FDA 510(k) (2 devices).

What risk classes do Dicom Grid Dba Ambra Health's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Dicom Grid Dba Ambra Health's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Dicom Grid Dba Ambra Health?

FDA recall records list 1 recall initiated by Dicom Grid Dba Ambra Health, the most recent initiated on 23 Jun 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Dicom Grid Dba Ambra Health in the registry?

The most recently registered devices listed for Dicom Grid Dba Ambra Health include Ambra ProViewer and Ambra PACS.

Generated automatically from registry data and not verified by a human reviewer.