SENTINELLA FP-0055
GUDID 08437018413027
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
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system Mobile gamma camera system| Primary Device ID | 08437018413027 |
| NIH Device Record Key | c32cc50c-e097-481f-aba9-5a7cb77965a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SENTINELLA |
| Version Model Number | SENTINELLA 102 HORUS |
| Catalog Number | FP-0055 |
| Company DUNS | 463337670 |
| Company Name | GENERAL EQUIPMENT FOR MEDICAL IMAGING SA |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
| Height | 185 Centimeter |
| Depth | 77 Centimeter |
| Width | 63 Centimeter |
| Weight | 134 Kilogram |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437018413027 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162052
FDA Product Code
| IYX | Camera, Scintillation (Gamma) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-24 |
| Device Publish Date | 2022-01-14 |
On-Brand Devices [SENTINELLA]
| 08437018413027 | Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of |
| 08437018413010 | Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of |
Trademark Results [SENTINELLA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENTINELLA 79313149 not registered Live/Pending |
General Equipment For Medical Imaging, S.A. 2021-04-14 |
 SENTINELLA 79088886 4027660 Live/Registered |
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S. A. 2010-07-27 |
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