Tomtec-Arena

FDA UDI

Class II (US FDA UDI)

by Tomtec Imaging Systems GmbH

Identity

Trade Name: TOMTEC-ARENA FDA UDI
Generic Name: Radiological PACS software FDA UDI
Device Name: TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. FDA UDI
Model / Reference: TTA2.41 FDA UDI
Description: TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. FDA UDI

Identifiers

Primary DI / UDI-DI: 04260361440174 FDA UDI
FDA Product Code: LLZ FDA UDI
QIH 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

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

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS software

Tomtec-Arena by Tomtec Imaging Systems GmbH — 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

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: Tomtec Imaging Systems GmbH

Sources (1)

FDA UDI cbd25889-a4d1-4ea4-a237-d8be3690b10c 33 fields · synced May 30, 2026