ALLURA XPER FD - Allura Xper Fd

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133292

by Philips Medical Systems Nederland B.V.

Identifiers

510(k) Number: K133292 FDA 510(k)
FDA Product Code: OWB FDA 510(k)
Models / Variants: Allura Xper Fd FDA 510(k)
Or Table FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1650 FDA 510(k)
Regulation Number: 892.1650 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

ALLURA XPER FD - Allura Xper Fd by Philips Medical Systems Nederland B.V. — 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

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K133292	Class II	Active

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Manufacturer

Manufacturer: Philips Medical Systems Nederland B.V.

Sources (1)

FDA 510(k) K133292 24 fields · synced Oct 6, 2026