Duns Number:968877360
Device Description: Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification Stationary digital specimen x-ray system with 6x15 cm imager intended for the verification of harvested biopsy specimens. The VersaVision x-ray cabinet is designed as a digital system, but can also be used with film.
Catalog Number
-
Brand Name
Faxitron
Version/Model Number
VersaVision 6x15
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
K170786
Product Code
MWP
Product Code Name
Cabinet,X-Ray System
Public Device Record Key
8b8009cf-fbe6-4aef-8d7b-d2ef6e576b1c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 09, 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. | 14 |