Delivery Analysis TM - Software, Delivery Analysis, Version 1.2 - ACCURAY INCORPORATED

Duns Number:785961244

Device Description: Software, Delivery Analysis, Version 1.2

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More Product Details

Catalog Number

NA

Brand Name

Delivery Analysis TM

Version/Model Number

1057375

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143269

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

5e9e85d6-0212-4dc3-9349-518a0ebcd383

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACCURAY INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 38