Pro Focus Ultraview Ultrasound System - Ultrasound scanner 2202 supports the following - Bk Medical ApS

Duns Number:310093901

Device Description: Ultrasound scanner 2202 supports the following scanning modes and combinations thereof:B-m Ultrasound scanner 2202 supports the following scanning modes and combinations thereof:B-mode (incl. Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations.The system can guide biopsy- and puncture needles.An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.An optional RF wireless function with the ability to wireless transmit for printing and archive purpose.

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More Product Details

Catalog Number

-

Brand Name

Pro Focus Ultraview Ultrasound System

Version/Model Number

2202

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 13, 2019

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

-

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

c6ab1a7c-5db3-4a70-8a29-c94753287db9

Public Version Date

June 15, 2022

Public Version Number

4

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BK MEDICAL APS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 92