FDA.reportPublic FDA data

Radiology Information Systems, Inc.

Primary DI
00860009490628
Brand
Radiology Information Systems, Inc.
Company
Radiology Information Systems, Inc.
Model
AccuImaging
Device description
Software module capable of taking an x-ray image generated by a CR or DR and producing a digitally enhanced image for projecting radiographic and/or fluoroscopic applications. AccuImaging is not indicated for use in mammography.
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K102849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102849000ACCULMAINGRadiology Information Systems, Inc.2010-11-23LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009490628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009490628008600094906288600094906280860009490628

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 manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
107343670
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009490642Radiology Information Systems, Inc.RSVS2022-12-01
00860009490604Radiology Information Systems, Inc.PowerDR 2022-12-01

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Primary DI, Brand, Company table
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