FDA.reportPublic FDA data

Neurolyser XR DQA Assembly

Primary DI
07290019747031
Brand
Neurolyser XR DQA Assembly
Company
FUSMobile LTD
Model
820-00008
Published
2025-12-10
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
SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue AblationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250015000Neurolyser XR (NXR100)Fusmobile, Inc.2025-11-14SGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290019747038PackageGS11In Commercial Distribution
07290019747031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001974703817290019747038
07290019747031072900197470317290019747031

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopic x-ray phantom, test objectA device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of fluoroscopic x-ray systems and associated image display systems, image acquisition software, and related system and application software programs.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Don't expose to sunlight
Storage Environment Temperature-10 Degrees Celsius27 Degrees Celsius

Regulatory Flags#

DUNS number
531885190
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019747000Neurolyser XRNXR1002025-12-10
07290019747017Neurolyser XR 30 mm Gel Pad 415-000022025-12-10
07290019747024Neurolyser XR 45 mm Gel Pad 415-000032025-12-10
17290019747038Neurolyser XR DQA Assembly820-000082025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019747000Neurolyser XRFUSMobile LTDSGN2025-12-10
07290019747017Neurolyser XR 30 mm Gel Pad FUSMobile LTDSGN2025-12-10
07290019747024Neurolyser XR 45 mm Gel Pad FUSMobile LTDSGN2025-12-10
17290019747038Neurolyser XR DQA AssemblyFUSMobile LTDSGN2025-12-10