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Dosimetry Check

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010225

by Math Resolutions, Llc

Identifiers

510(k) Number
K010225 FDA 510(k)
FDA Product Code
IYE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Dosimetry Check by Math Resolutions, Llc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K010225 24 fields · synced Jun 19, 2026