FDA.report

eRAD RIS

Primary DI
00866994000231
Brand
eRAD RIS
Company
ERAD, INC.
Model
2.16
Device description
eRAD RIS v2.2016
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

Related Records

Contact Domains

Product Codes

CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions

SubmissionSupplement
K120995000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00866994000231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00866994000231008669940002318669940002310866994000231

GMDN Terms

TermDefinition
Radiology information system application softwareAn application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
00866994000255eRAD PACS92023-10-30
00866994000262eRAD RIS4.222022-12-06
00866994000200eRAD PACS7.22016-05-02
00866994000217eRAD PACS7.32016-05-02
00866994000224eRAD PACS Evolution8.02016-06-01
00866994000248eRAD RIS3.182018-01-01

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