WristView

Primary DI
00858755006101
Brand
WristView
Company
ASPECT IMAGING LTD
Model
WristView
Catalog number
70006200
Device description
The Wrist\view MRI System is a 1T Permanent magnet MRI scanner. It is indicated for Wrist and Hand imaging. The imaging volume is an ellipsoid with dimensions of 120mm X 120 mm X 70mm around the magnet center. The overall dimensions of the magnet assembly are 140 cm x 100 cm x 235 cm [with patient trolley].
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160185000Wrist 3Aspect Imaging, Ltd.2016-03-01LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858755006101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858755006101008587550061018587550061010858755006101

GMDN Terms#

Term, Definition table
TermDefinition
Extremity MRI system, permanent magnetA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533254041
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858755006309Embrace Neonatal MRI SystemEmbrace700070002018-03-29

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Primary DI, Brand, Company table
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