Allura 3D-CA

FDA UDI

Class II (US FDA UDI)

by Philips Medical Systems Nederland B.V.

Identity

Trade Name: Allura 3D-CA 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. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run. FDA UDI
Model / Reference: Allura 3D-CA - 3 FDA UDI
Description: Software medical device, used with a Philips Interventional X-Ray System. Creates a 3D model of the coronary vessel tree from a pair of 2D images from a rotational angiographic run. FDA UDI

Identifiers

Catalog Number: 001009 FDA UDI
Primary DI / UDI-DI: 00884838059245 FDA UDI
510(k) Number: K042334 FDA UDI
FDA Product Code: LLZ FDA UDI
IZI 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
892.1600 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Angiographic x-ray system application software

Allura 3D-CA by Philips Medical Systems Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Angiographic x-ray system application software.

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Dynamic Coronary Roadmap — Philips Medical Systems Nederland B.V. · Class II
Dynamic Coronary Roadmap — Philips Medical Systems Nederland B.V. · Class II
2D Perfusion — Philips Medical Systems Nederland B.V. · Class II
3D-CA — Philips Medical Systems Nederland B.V. · Class II

Cleared under the same submission

K042334 also covers:

3D-CA — Philips Medical Systems Nederland B.V.

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 d608ca57-210f-4e14-9a15-242abfd2f281 35 fields · synced Sep 18, 2026