Organization name

DeepHealth, Inc.

SRN

US-MF-000051664

Manufacturer status

Active

Primary placement in Germany; available across 25 countries total.

Trade name

Brain Health

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.

00860005144075

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.

8600051440023T3

Reference / catalog number

1.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

Brain Health is a software as a medical device (SaMD) that provides automatic analysis of Magnetic Resonance (MR) images of the brain to allow for visualization, localization and quantification of white matter hyperintensities (WMHs). The software is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. As input scans, the device uses T2 weighted fluid-attenuated inversion recovery (FLAIR) MR images. This can be a single scan per patient, or a combination of one or multiple earlier scan(s) and a follow-up scan to perform a longitudinal analysis. The scans are presented to the device via an external orchestration device. This orchestration device indicates if the analysis is single timepoint only or that longitudinal analysis is required on a set of input scans.

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

Certificate health across this manufacturer's portfolio.