Duns Number:065626069
Device Description: Software application that provides internet access to multi-modality softcopy medical imag Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.
Catalog Number
-
Brand Name
Merge iConnect Access
Version/Model Number
6.4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092915
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
c35c419e-7753-46b1-a4d1-f6f271698d77
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |