Duns Number:508663101
Device Description: The CellaVision remote review software enable up to 5 concurrent remote users to access da The CellaVision remote review software enable up to 5 concurrent remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
Catalog Number
CRRS-TE6099
Brand Name
CellaVision® Remote Review Software, Team Edition, version 6.0.x
Version/Model Number
CRRS-TE6099
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 15, 2019
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
K102778
Product Code
JOY
Product Code Name
Device, Automated Cell-Locating
Public Device Record Key
5f2fcb94-c0f8-4210-8818-f801e9e7acb6
Public Version Date
March 22, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2016
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 |