Data / Medical devices / United States / DICOM Grid (dba Ambra Health)
DICOM Grid (dba Ambra Health): FDA-registered device maker in Raleigh, NC, United States, 1 510(k) clearance
DICOM Grid (dba Ambra Health) is registered with the FDA (registration 3008776294) in Raleigh, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2023. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008776294
- Address
- 305 Church at North Hills St 6th Floor, Raleigh, NC, United States, 27609
- Owner or operator
- DICOM Grid dba Ambra Health dba Intelerad Holdings USA Ltd (10034899)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 17, 2011
- Registered through
- 2026
- Brand names listed
- Ambra Mobile Application, Ambra PACS, InteleShare
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 7, 2023 | K231360 | Ambra PACS | LLZ | Substantially Equivalent | Dicom Grid Dba Ambra Health | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 18, 2025 | 97993 | Class II | Ongoing | Intelerad InteleShare software, with ProViewer component | Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to m | accessdata.fda.gov |
| June 23, 2022 | 90817 | Class II | Ongoing | Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images. | 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. | accessdata.fda.gov |
| December 16, 2016 | 76187 | Class II | Terminated | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. | A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
Updated December 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.