Upright MRI

Primary DI
00810136130010
Brand
Upright MRI
Company
FONAR CORPORATION
Model
1
Device description
The UPRIGHT® MRI is intended for use as a magnetic resonance diagnostic device (MRDD) that produces axial, sagittal, coronal, and oblique cross sectional images of the human body. The UPRIGHT® MRI enables acquisition of Magnetic Resonance (MR) images of the human body in an open di-pole magnet that accommodates a wide variety of static and dynamic patient postures, for example, sitting; standing; upright flexion, extension, lateral bending, and rotation; and recumbent. When interpreted by a trained physician, the resultant MR images can yield diagnostically useful information.
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002490000
K003453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002490000INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNERFonar Corp.2000-10-03LNH
K003453000SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERSFonar Corp.2001-01-18LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810136130010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136130010008101361300108101361300100810136130010

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, resistive magnetA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). It includes a resistive magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be modified through the addition of software/hardware modules to perform MR spectroscopy and various real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in various gantry configurations, e.g. Closed bore, open bore, open-sided or other patient accessible designs.

Regulatory Flags#

DUNS number
037048154
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

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