Primary Device ID | 00860183001504 |
NIH Device Record Key | 5445cb38-3e97-4a59-b73e-7de2f38e243c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Zap-X Radiosurgery System |
Version Model Number | 300150 |
Company DUNS | 082344400 |
Company Name | ZAP SURGICAL SYSTEMS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
00860183001504 - Zap-X Radiosurgery System | 2018-10-01The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation. |
00860183001504 - Zap-X Radiosurgery System | 2018-10-01 The Zap-X Radiosurgery System (“Zap-X System”) is a computer-controlled system for performing non-invasive stereotactic radi |
00860183001511 - Zap-X Treatment Delivery Software | 2018-10-01 The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com |
00860183001528 - Zap-X Treatment Planning Software | 2018-10-01 The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a com |
00860183001535 - Zap-X MV Imager | 2018-10-01 The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled s |