Identifiers
- 510(k) Number
- K123408 FDA 510(k)
- FDA Product Code
- IYX FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1100 FDA 510(k)
- Regulation Number
- 892.1100 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ergo Imaging System by Digirad Corp. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123408 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Digirad Corp.
Sources (1)
- FDA 510(k) K123408 24 fields · synced Jun 19, 2026