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1.5T 8-CHANNEL SMALL EXTREMITY COIL - Model 800484
FDA 510(k)Class II (US FDA 510(k))
510(k) K091902
by Invivo
Identifiers
- 510(k) Number
- K091902 FDA 510(k)
- FDA Product Code
- MOS FDA 510(k)
- Models / Variants
- 800494 FDA 510(k)3.0t 8-Channel Small Extremity Coil FDA 510(k)Model 800484 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)
1.5T 8-CHANNEL SMALL EXTREMITY COIL - Model 800484 by Invivo — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K091902 | Class II | Active |
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Manufacturer
- Manufacturer
- Invivo
Sources (1)
- FDA 510(k) K091902 24 fields · synced Jun 18, 2026