DICOM Grid, Inc.
FDA Regulatory Profile
DICOM Grid, Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0941-2026, Class II) was initiated on November 18, 2025. Its most recent 510(k) clearance was granted on January 25, 2016.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0941-2026 | Class II | Intelerad InteleShare software, with ProViewer component | November 18, 2025 |
| Z-1045-2017 | Class II | Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 In | December 16, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152977 | DG PACS | January 25, 2016 |