Duns Number:508663101
Device Description: The CellaVision remote review software enable remote users to access data collected, store The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.
Catalog Number
AG516335
Brand Name
DI Remote Review Software version 6.x.x
Version/Model Number
AG516335
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092868
Product Code
JOY
Product Code Name
Device, Automated Cell-Locating
Public Device Record Key
d41f6ca8-7d29-448e-acc0-ab94c749d4b9
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
February 19, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |