FDA.report

HealthMyne QIDS

Primary DI
B198HM0080
Brand
HealthMyne QIDS
Company
HEALTHMYNE, INC.
Model
8.0
Published
2019-06-19
Public version status
New
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

Product Codes

CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B198HM0080PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
078786040
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
B198HM0081HealthMyne QIDS8.12019-07-26
B198HM0102HealthMyne10.22020-03-25
B1984M0011R20HealthMyne11.22021-05-04
B198HM01160HealthMyne11.62021-05-04
B198HM0120HealthMyne12.0HMV122021-05-04
B198HM01210HealthMyne12.12021-05-04
B198HM01220HealthMyne12.22021-05-04
B198HMV11R1PK0HealthMyne11.12021-05-04
B198HMV11R30HealthMyne11.32021-05-04
B198HMV11R40HealthMyne11.42021-05-04
B198HMV11R50HealthMyne11.52021-05-04
B198HMV11R70HealthMyne11.7HMV11R72021-05-04
B198HM0110HealthMyne11.02020-08-17
B198HM0101HealthMyne10.12020-03-06
B198HM0100HealthMyne10.02020-02-14
B198HM0071HealthMyne QIDS7.12019-03-29
B198HM0070HealthMyne QIDS7.02019-02-15
B198HM0082HealthMyne QIDS8.22019-10-21
B198HM0083HealthMyne QIDS8.32019-10-21
B198HM0090HealthMyne QIDS9.02019-10-21

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