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Sentinella 102 Horus
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref FP-0055Model SENTINELLA, SENTINELLA 102, SENTINELLA 102 HORUS, SENTINELLA HORUS
Identity
- Trade Name
- SENTINELLA 102 HORUS EUDAMEDSENTINELLA FDA UDI
- Generic Name
- Mobile gamma camera system FDA UDI
- Device Name
- SENTINELLA EUDAMEDSentinella 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 EUDAMEDFP-0055 EUDAMEDSENTINELLA 102 HORUS 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-0055 FDA UDI
- Primary DI / UDI-DI
- 08437018413027 EUDAMEDFDA UDI
- Basic UDI-DI
- 8437018413GAMMACAMERAN4 EUDAMED
- Direct Marketing DI
- 08437018413027 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 EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1100 FDA UDI
- 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 UDIDepth — 77 Centimeter FDA UDIWidth — 63 Centimeter FDA UDIWeight — 134 Kilogram FDA UDI
Sentinella 102 Horus 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
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143156 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K162052 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8437018413GAMMACAMERAN4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- General Equipment For Medical Imaging, S.a.
- EUDAMED SRN
- ES-MF-000013779
Sources (3)
- EUDAMED a00fd667-928c-4f0f-8919-150863153719 61 fields · synced Jul 20, 2026
- FDA UDI c32cc50c-e097-481f-aba9-5a7cb77965a9 37 fields · synced May 30, 2026
- FDA 510(k) K143156 1 fields · synced May 18, 2026