Catalog Number

Rapid

Brand Name

Rapid

Version/Model Number

5.2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

K182130,K193087,K200760,K200941

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

bab1f58a-3419-43f5-b11c-a16fe7241609

Public Version Date

September 13, 2022

Public Version Number

2

DI Record Publish Date

May 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-