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Advantage Windows 3d Option And Dentascan Option

FDA 510(k)

Class II (US FDA 510(k))

510(k) K923077

by Ge Medical Systems

Identifiers

510(k) Number
K923077 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Advantage Windows 3d Option And Dentascan Option by Ge Medical Systems — 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

Manufacturer
Ge Medical Systems

Sources (1)

  • FDA 510(k) K923077 24 fields · synced Jun 18, 2026