AccessGUDID - DEVICE: Zap-X Treatment Delivery Software (00860183001511)

GUDID

Device Identifier (DI) Information

Brand Name: Zap-X Treatment Delivery Software
Version or Model: 300151
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZAP SURGICAL SYSTEMS, INC.

Primary DI Number: 00860183001511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082344400 *Terms of Use

Device Description: The Zap-X Treatment Delivery 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
18054	Stereotactic radiosurgery/radiation therapy linear accelerator system	A stationary assembly of computer-based devices designed to produce high-energy electrons to yield high-energy x-rays used to perform stereotactic radiosurgery (SRS) to treat brain, neck, or spinal cord tumours, and/or to perform stereotactic body radiation therapy (SBRT). It consists of a linear accelerator with a moveable/rotating gantry, collimators, patient table, and an operator's console. A metal head frame attached to the patient's skull may be used for precise radiation beam targeting using fiducial references; the system may include CBCT-based image-guided radiation therapy (IGRT), 3-D imaging, and record/verify functionalities to track target location during treatment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171804	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c9027769-f163-4a35-b8ab-18ea7bd15158
Public Version Date: October 01, 2018
Public Version Number: 1
DI Record Publish Date: August 29, 2018