Catalog Number

10410000Z

Brand Name

SNC125c Scanning Ionization Chamber (BNC)

Version/Model Number

10410000Z

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2019

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

K112981

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Public Device Record Key

5d748da6-33aa-485a-b094-66138d5825fc

Public Version Date

April 15, 2019

Public Version Number

5

DI Record Publish Date

January 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-