G-scan Brio

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 101002000Model 101002510(k) K133490

by Esaote S.p.A.

Identity

Trade Name: G-scan Brio EUDAMEDFDA UDI
Generic Name: Extremity MRI system, permanent magnet FDA UDI
Model / Reference: 101002 EUDAMED
101002000 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 08056304450029 EUDAMEDFDA UDI
Basic UDI-DI: B-08056304450029 EUDAMED
FDA Product Code: MOS FDA UDI
LLZ FDA UDI
LNH FDA UDI
EMDN Code: Z11050101 SECTORAL TOMOGRAPHS (FOR TOMOGRAPHIC EXAMINATIONS OF THE EXTREMITIES) EUDAMED
GMDN Term: Extremity MRI system, permanent magnet FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
892.2050 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

The G-Scan Brio is a weight-bearing magnetic resonance imaging (MRI) system designed for musculoskeletal applications. It combines open and tilting design principles to facilitate patient positioning during imaging, enabling more accurate and reproducible diagnostic assessments of joint and soft tissue conditions under functional load.

This device is supplied as a reusable MRI system (non-sterile) and is classified as Class IIa under the Medical Device Directive (MDD). It is intended for use in clinical settings equipped for MRI procedures, with regulatory authorisations including FDA 510(k) clearance (K133490) and MDD compliance. The system operates under UDI B-08056304450029 and is manufactured by Esaote S.p.A.

Frequently asked questions

What is the G-Scan Brio MRI system designed for?

The G-Scan Brio is a weight-bearing MRI system designed for musculoskeletal applications, featuring an open and tilting design to facilitate patient positioning during imaging for more accurate diagnostic assessments of joint and soft tissue conditions under functional load.

How is the G-Scan Brio supplied and is it reusable?

The G-Scan Brio is supplied as a reusable MRI system (non-sterile) and is classified as Class IIa under the Medical Device Directive (MDD). It is intended for use in clinical settings equipped for MRI procedures.

What regulatory authorizations does the G-Scan Brio have?

The G-Scan Brio has FDA 510(k) clearance (K133490) and MDD compliance. It operates under UDI B-08056304450029 and is manufactured by Esaote S.p.A.

What are the key features of the G-Scan Brio MRI system?

The G-Scan Brio combines open and tilting design principles to facilitate patient positioning during imaging, enabling more accurate and reproducible diagnostic assessments of joint and soft tissue conditions under functional load.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: G-scan Brio: new Weight-Bearing MRI system - Esaote, G-scan Brio | EASTECH, PDF The Key to Confidence - Esaote

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K142421	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K122006	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K180592	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K161973	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K133490	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-08056304450029	Class IIa	Active

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Manufacturer

Manufacturer: Esaote S.p.A.
EUDAMED SRN: IT-MF-000019024
FDA Applicant: Esaote, S.p.A.

Sources (3)

EUDAMED 4ced238e-99a4-40ba-8687-d481f20e8cf8 85 fields · synced Sep 18, 2026
FDA UDI 670d062c-dfd0-47b7-ac6f-c2b1e3c2a49b 32 fields · synced May 30, 2026
FDA 510(k) K142421 1 fields · synced May 18, 2026