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LOGIQ P9 - Logiq P9

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181783

by GE Healthcare

Identifiers

510(k) Number: K181783 FDA 510(k)
FDA Product Code: IYN FDA 510(k)
Models / Variants: Logiq P9 FDA 510(k)
Logiq P7 FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1550 FDA 510(k)
Regulation Number: 892.1550 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

LOGIQ P9 - Logiq P9 by GE Healthcare — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: GE Healthcare

Sources (1)

FDA 510(k) K181783 24 fields · synced Jun 18, 2026