SENTINELLA

Basic Information

• Brand Name: SENTINELLA
• Primary DI: 08437018413010
• Version / Model: SENTINELLA 102
• Catalog Number: FP-0040
• Company Name: GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
• Labeler DUNS: 463337670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-14
• Public Version: 1
• Public Version Date: 2022-01-24
• Public Version Status: New
• Public Device Record Key: 9dafc27b-d1ea-458f-8deb-05cb588b43e0

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYX	Camera, Scintillation (Gamma)	Radiology	892.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40641	Mobile gamma camera system	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437018413010	GS1

Premarket Submissions

Submission Number	Supplement Number
K162052	000

Device Sizes

Type	Value	Unit	Text
Height	185	Centimeter
Depth	77	Centimeter
Width	63	Centimeter
Weight	134	Kilogram

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius