FDA.reportPublic FDA data

eRAD PACS

Primary DI
00866994000200
Brand
eRAD PACS
Company
ERAD, INC.
Model
7.2
Device description
eRAD PACS v7.2
Published
2016-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K120995000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120995000ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCTErad, Inc.2012-12-03LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866994000200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866994000200008669940002008669940002000866994000200

GMDN Terms#

Term, Definition table
TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-414-3723csc@erad.com

Regulatory Flags#

DUNS number
023594885
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866994000255eRAD PACS92023-10-30
00866994000262eRAD RIS4.222022-12-06
00866994000217eRAD PACS7.32016-05-02
00866994000224eRAD PACS Evolution8.02016-06-01
00866994000231eRAD RIS2.162016-05-02
00866994000248eRAD RIS3.182018-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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17540262140255Change Healthcare Stratus Imaging ViewerChange Healthcare Canada CompanyLLZ2026-03-19
08800018412008EConsole2DRTECH CorporationLLZ2026-03-17
75401622502288Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-03-17
00860010575314AS SoftwareAs Software, LLCLLZ2026-03-10
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04719878870009EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870108EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870122EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870191EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870276EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870290EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
09358140000079Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-03-09
17540262090154Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-03-09
06971576834334uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
06971576834341uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
07350092810678Sectra Orthopedic PackageSectra ABLLZ2026-03-05
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LLZ2026-02-27
08800169200134ON3D3D ONS, INC.LLZ2026-02-19
B403IQS11004iQ-SYSTEM PACSIMAGE Information Systems Europe GmbHLLZ2026-02-19
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00860015443526CARPLCarpl.AI, Inc.LLZ2026-02-16