SonoScape - X6 Pro Digital Color Doppler Ultrasound System - SONOSCAPE MEDICAL CORP.

Duns Number:545342185

Device Description: X6 Pro Digital Color Doppler Ultrasound System

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More Product Details

Catalog Number

-

Brand Name

SonoScape

Version/Model Number

X6 Pro

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182648

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

efcca8b1-9f8e-4c5f-91ce-c694b8b43b4e

Public Version Date

April 09, 2019

Public Version Number

1

DI Record Publish Date

April 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONOSCAPE MEDICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 352