Organization name

eRAD, Inc.

SRN

US-MF-000018514

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Irreversibly (lossy) compressed images and digitized film images should not be used for primary diagnosis of mammography studies.

Primary placement in Austria; available across 32 countries total.

Trade name

eRAD Viewer

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00860014963742

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

08600149637ViewerXR

Reference / catalog number

9.y.z

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The viewer is a software-only, web-based medical image management and processing system, comprised of data acquisition and registration services, a central systems manager, clinical and diagnostic viewers, and a data archive. The system is used by qualified healthcare providers to the presentation, review and comparison of diagnostic medical images.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z119082VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - SOFTWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

This device is not currently linked to any other device.

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.