FDA.reportPublic FDA data

HealthView CardioPACS

Primary DI
00857560008003
Brand
HealthView CardioPACS
Company
Lumedx Corporation
Model
6.5.1
Catalog number
113-00749
Device description
CardioPACS is a software device intended to be used by medical professionals for storage, review, query/ retrieve, analysis, and post processing of DICOM medical images that are generated by echocardiography, radiology, and other modalities. The device can be used as a stand-alone product or in a networked system. CardioPACS is not intended for use with mammograms.
Published
2018-08-13
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
K120514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120514000CARDIOPACSLumedx2012-07-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857560008003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857560008003008575600080038575600080030857560008003

Contacts#

Phone, Email table
PhoneEmail
801-891-4570regulatory-affairs@intelerad.com

Regulatory Flags#

DUNS number
625427471
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00857560008010HealthView ECG Manager1.2.5113-010032018-11-30

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Primary DI, Brand, Company table
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