bkSpecto Ultrasound System - The 1300 Ultrasound Scanner is a multi-purpose - Bk Medical ApS

Duns Number:310093901

Device Description: The 1300 Ultrasound Scanner is a multi-purpose mobile, software controlled diagnostic ult The 1300 Ultrasound Scanner is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. It includes the following scanning modes: B, B+M, B+D, B+C, B+D+C . (D is PWD, C is Color Flow mapping Doppler including Velocity and Variance display, Amplitude(power)Doppler including directional display ). B mode includes Tissue Harmonic Imaging , VFI (Vector Flow Imaging), Elastography, Contrast Imaging, CW doppler. The system performs simple geometric measurements and calculations in the following areas: Urology, Vascular, Cardiology, OB/GYN, Emergency Medicine, Surgery, and Anesthesia. Optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

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More Product Details

Catalog Number

1300

Brand Name

bkSpecto Ultrasound System

Version/Model Number

1300

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

K173569

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

81d568ae-0ce3-4c5a-9668-68d6654ea811

Public Version Date

June 15, 2022

Public Version Number

2

DI Record Publish Date

July 12, 2018

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