FlexView Diagnostic

Primary DI
00860011710202
Brand
FlexView Diagnostic
Company
Radical Imaging LLC
Model
1.2.7
Device description
FlexView Diagnostic is a stand-alone Web-based DICOM medical image viewer which allows downloading, reviewing, manipulating, and visualizing medical multi-modality image data in DICOM format and other data. FlexView Diagnostic is a server-based solution that may integrate with healthcare facility software systems and display DICOM images. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software.
Published
2024-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233226000FlexView Diagnostic (v1.1.20)Radical Imaging, LLC2024-01-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011710202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011710202008600117102028600117102020860011710202

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(508) 251-9379info@flexview.ai

Regulatory Flags#

DUNS number
080438649
Device count
1

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