Zap-X MV Imager - The Zap-X MV Imager is designed for use with the - ZAP SURGICAL SYSTEMS, INC.

Duns Number:082344400

Device Description: The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap-X System” The Zap-X MV Imager 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.

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More Product Details

Catalog Number

-

Brand Name

Zap-X MV Imager

Version/Model Number

300153

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

00dda49e-ac34-4ffe-94dc-17d904d9591c

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZAP SURGICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4