Duns Number:082344400
Device Description: The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery Syst The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
Catalog Number
-
Brand Name
Zap-X Treatment Planning Software
Version/Model Number
300152
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
K171804
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
7ac51530-1a6a-4add-8891-4ebba6a7ac04
Public Version Date
October 01, 2018
Public Version Number
1
DI Record Publish Date
August 29, 2018
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. | 4 |