Flex Focus Ultrasound System - Ultrasound scanner 1202 and transducers for B, - Bk Medical ApS

Duns Number:310093901

Device Description: Ultrasound scanner 1202 and transducers for B, Tissue and Contrast Harmonic Imaging, M, PW Ultrasound scanner 1202 and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.Signal analysis and display.Guidance of biopsy needles, geometrical measurements and calculation of parameters.An optional 3-D unit 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 connectivity purpose.Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Flex Focus Ultrasound System

Version/Model Number

1202

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

-

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

5c6b7456-9a73-42b9-bc57-9d80cad121ba

Public Version Date

May 23, 2018

Public Version Number

3

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