FDA.reportPublic FDA data

S-scan

Primary DI
08056304451095
Brand
S-scan
Company
ESAOTE SPA
Model
9800020010
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056304451095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056304451095080563044510958056304451095

GMDN Terms#

Term, Definition table
TermDefinition
Extremity MRI system, permanent magnet"A diagnostic magnetic resonance imaging (MRI) system employing permanent magnet technology specifically designed to image only the head and neck or limbs. Extremity imaging systems are typically closed bore designs with cylindrical or rectangular bore openings but can be ""open"" bore designs. They include MRI systems with conventional extremity imaging capabilities, conventional systems capable of performing spectroscopy or other real-time imaging procedures necessary for interventional and therapeutic MRI applications, and dedicated MR spectroscopy systems."

Regulatory Flags#

DUNS number
437384304
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056304454737Magnifico Open1000099002022-02-21
08056304455826MyLabC251007611002025-12-10
08056304455833MyLabC301007611202025-12-10
08056304450296MyLabSix CrystallLine1006425002016-11-29
08056304452597MyLabSeven 1016400022017-02-24
08056304452603MyLabEight eXP1016200302017-04-03
08056304452610MyLabEight1016250302017-04-03
08056304452658MyLab 9 eXP1006440002018-02-19
08056304452917C 1-81200000132018-02-19
08056304452924L 3-111200000142018-02-19
08056304452931P 1-51200000152018-02-19
08056304452948PA2501200000322018-02-19
08056304453037MyLabSix CrystaLine 1006425012017-02-24
08056304453068L 8-241200000372018-02-19
08056304453105L 4-151200000362018-02-19
08056304453150mC 3-111200000462018-02-19
08056304455017MyLabA501006610002025-07-07
080563044550622CWL1200001062025-07-07
080563044550795CWL1200001072025-07-07
08056304455215MyLabE851006450852025-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
04260486610483NHAC 1.5T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610537NHAC 3.0T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610582NBAC 1.5T PH I SpineLMT Medical Systems GmbHMOS2024-04-23
04260486610599NBAC 3.0T PH I SpineLMT Medical Systems GmbHMOS2024-04-23