SmartPerfusion

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Nederland B.V.

Identity

Trade Name: SmartPerfusion FDA UDI
Generic Name: Angiographic x-ray system application software FDA UDI
Device Name: Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues. FDA UDI
Model / Reference: SmartPerfusion - 1 FDA UDI
Description: Software medical device used with a Philips Interventional X-Ray System. Provides color coded representation of digital subtraction angiography to assist diagnosis of perfusion alterations of tissues. FDA UDI

Identifiers

Catalog Number: 001119 FDA UDI
Primary DI / UDI-DI: 00884838088566 FDA UDI
510(k) Number: K181966 FDA UDI
FDA Product Code: LLZ FDA UDI
OWB FDA UDI
GMDN Term: Angiographic x-ray system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.1650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

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Manufacturing Date

FDA UDI

Category: Angiographic x-ray system application software

SmartPerfusion by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Philips Medical Systems Nederland B.V.

Sources (1)

FDA UDI f97b8a45-dab0-4bc8-8e5c-60bfc52417ab 35 fields · synced Sep 18, 2026