FDA.reportPublic FDA data

SENTINELLA

Primary DI
08437018413010
Brand
SENTINELLA
Company
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Model
SENTINELLA 102
Catalog number
FP-0040
Device 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
Published
2022-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYXCamera, Scintillation (Gamma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYXCamera, Scintillation (Gamma)Radiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162052000Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-2016-08-18IYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437018413010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437018413010084370184130108437018413010

GMDN Terms#

Term, Definition table
TermDefinition
Mobile gamma camera systemAn assembly of mobile diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It uses Anger or non-Anger detection methods and consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, a sodium iodide (Nal) crystal(s), a collimator and a set of photomultiplier tubes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth77Centimeter
Height185Centimeter
Weight134Kilogram
Width63Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
463337670
Device count
1
DM exempt
true
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437018413188CAREMIBRAINFP-0600FP-06002024-05-28
08437018413294GAMMAPROANGLEDIC-11802023-01-18
08437018413072WPROBESTDIC-11502021-12-01
08437018413089WPROBELAPIC-11702021-12-01
08437018413096WPROBEHI-SIC-11602021-12-01
08437018413027SENTINELLASENTINELLA 102 HORUSFP-00552022-01-14
08437018413034MAMMIMAMMI SRFP-02022022-01-14
08437018413041MAMMIMAMMI DRFP-02032022-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859873006219Hermia OLINDAHermes Medical Solutions ABIYX2026-03-10
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B843UNISYN7510UniSynConvergent Imaging Solutions IncorporatedIYX2025-08-20
00810149098000R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-07-14
00810149097966R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-05-22
00810149097928R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-03-04
00810149097799R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097836R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
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00810149097737R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-29
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00810149097706R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-07
00810149097683R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
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00810149090158R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090196R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090202R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01