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Sentinella 102

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref FP-0040Model SENTINELLA, SENTINELLA 102, SENTINELLA 102 HORUS, SENTINELLA HORUS510(k) K110601

by General Equipment For Medical Imaging, S.a.

Identity

Trade Name
SENTINELLA 102 EUDAMED
SENTINELLA FDA UDI
Generic Name
Mobile gamma camera system FDA UDI
Device Name
SENTINELLA EUDAMED
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus FDA UDI
Model / Reference
SENTINELLA, SENTINELLA 102, SENTINELLA 102 HORUS, SENTINELLA HORUS EUDAMED
FP-0040 EUDAMED
SENTINELLA 102 FDA UDI
Description
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus FDA UDI

Identifiers

Catalog Number
FP-0040 FDA UDI
Primary DI / UDI-DI
08437018413010 EUDAMEDFDA UDI
Basic UDI-DI
8437018413GAMMACAMERAN4 EUDAMED
Direct Marketing DI
08437018413010 EUDAMED
510(k) Number
K162052 FDA UDI
FDA Product Code
IYX FDA UDI
EMDN Code
Z11020101 MOBILE GAMMA CAMERAS EUDAMED
GMDN Term
Mobile gamma camera system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
892.1100 FDA UDI
Market of Registration
Spain EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

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

Yes

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

No

FDA UDI

Dimensions & Sizes

Size
Height — 185 Centimeter FDA UDI
Depth — 77 Centimeter FDA UDI
Width — 63 Centimeter FDA UDI
Weight — 134 Kilogram FDA UDI

Sentinella 102 by General Equipment For Medical Imaging, S.a. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
General Equipment For Medical Imaging, S.a.
EUDAMED SRN
ES-MF-000013779

Sources (3)

  • EUDAMED 11d813a6-d8e5-461e-9c89-bc77c49e1e5d 85 fields · synced Jun 18, 2026
  • FDA UDI 9dafc27b-d1ea-458f-8deb-05cb588b43e0 37 fields · synced May 30, 2026
  • FDA 510(k) K110601 1 fields · synced May 18, 2026