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EXSYS DEXi (EXSYS DEXi-D401S-FRM) +13 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K242847
Identifiers
- 510(k) Number
- K242847 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
- Models / Variants
- EXSYS DEXi (EXSYS DEXi-D401S-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-A401S-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D402S-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-A402S-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D401P-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-A401P-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D402P-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-A402P-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D503T-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-A503T-FRM) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D401S-FRA) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D402S-FRA) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D401P-FRA) FDA 510(k)EXSYS DEXi (EXSYS DEXi-D402P-FRA) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EXSYS DEXi (EXSYS DEXi-D401S-FRM) +13 more models by DRTECH Corporation — Class II — FDA_510K — listed in FDA 510(k) — 14 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 | K242847 | Class II | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
Sources (1)
- FDA 510(k) K242847 24 fields · synced Jun 18, 2026