Catalog Number

-

Brand Name

HITACHI

Version/Model Number

DAS-RS1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2021

Issuing Agency

In GS1

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

K081843

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

4eb20209-c98e-46d4-97e7-fb25a7c01d5c

Public Version Date

July 05, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-