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S-scan Open

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 100001800Model 100001Ref 9800020015Model 980002

by Esaote S.p.A.

Identity

Trade Name
S-scan Open EUDAMEDFDA UDI
S-scan EUDAMEDFDA UDI
Generic Name
Extremity MRI system, permanent magnet FDA UDI
Device Name
Standard Configuration FDA UDI
Model / Reference
100001 EUDAMED
100001800 EUDAMEDFDA UDI
9800020015 EUDAMEDFDA UDI
980002 EUDAMED
Description
Standard Configuration FDA UDI

Identifiers

Primary DI / UDI-DI
08056304455055 EUDAMEDFDA UDI
08056304450074 EUDAMEDFDA UDI
Basic UDI-DI
805630445ESA.MR0000004.Q5 EUDAMED
B-08056304450074 EUDAMED
FDA Product Code
LNH FDA UDI
MOS FDA UDI
EMDN Code
Z11050102 OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T EUDAMED
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
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

S-scan Open by Esaote S.p.A. — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Esaote S.p.A.
EUDAMED SRN
IT-MF-000019024

Sources (5)

  • EUDAMED ee0a37d8-f297-41ae-860f-8077ed391643 61 fields · synced Jul 9, 2026
  • FDA UDI 9417c4f7-8076-42cb-9c2c-7486e1d805b4 32 fields · synced May 29, 2026
  • FDA UDI 6ee285c4-1798-49c2-9511-b5222b9769e8 33 fields · synced May 30, 2026
  • EUDAMED 4d872a4b-e9f6-48d9-bbe3-f6f743060597 61 fields · synced Jul 9, 2026
  • FDA 510(k) K260746 1 fields · synced May 18, 2026