Identifiers
- 510(k) Number
- K060956 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
- Models / Variants
- 9800020000 FDA 510(k)E-Scan Model 9800010000 FDA 510(k)E-Scan Xq-Models-9800010011 FDA 510(k)9800010005 FDA 510(k)9800010009 FDA 510(k)9800010004 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
G-Scan- (9800020000 +5 more) by Esaote S.p.A. — Class II — FDA_510K — listed in FDA 510(k) — 6 models — 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 | K060956 | Class II | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- FDA Applicant
- Esaote, S.p.A.
Sources (1)
- FDA 510(k) K060956 24 fields · synced Jun 18, 2026