VolparaDensity

FDA UDI

Class II (US FDA UDI)

by Volpara Health Technologies Limited

Identity

Trade Name: VolparaDensity FDA UDI
Generic Name: Radiological PACS software FDA UDI
Device Name: VolparaDensity 3.4.2 FDA UDI
Model / Reference: 3.4.2 FDA UDI
Description: VolparaDensity 3.4.2 FDA UDI

Identifiers

Primary DI / UDI-DI: 09421904268258 FDA UDI
510(k) Number: K153427 FDA UDI
FDA Product Code: LLZ FDA UDI
GMDN Term: Radiological PACS software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiological PACS software

VolparaDensity by Volpara Health Technologies Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

AVIEW — CORELINE SOFT CO., LTD. · Class II
ThinkingNet — THINKING SYSTEMS CORP. · Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
QuantX — Qlarity Imaging · Class II
interWORKS — Avreo, Inc. · Class I
NovaPACS — Novarad Corporation · Class II
OrthoNext™ Platform System Software — Orthofix, Inc. · Class II

Cleared under the same submission

K153427 also covers:

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: Volpara Health Technologies Limited

Sources (1)

FDA UDI 8553a3be-ece4-486a-8ba9-8f97203905ce 34 fields · synced Jun 1, 2026