DEVICE: bk3000, bk3500 & bk5000 Ultrasound System (05704916000264)

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Device Identifier (DI) Information

bk3000, bk3500 & bk5000 Ultrasound System
2300

Bk Medical ApS
05704916000264
GS1
1
Ultrasound Scanner System bk2300 with the addition of an optional system with an alternate power source (battery) solution is intended for the diagnostic ultrasound imaging or fluid flow analysis of the human body and includes the following: Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optimal 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General ultrasound imaging system, line-powered An assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.
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FDA Product Code

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Product Code Product Code Name
ITX Transducer, Ultrasonic, Diagnostic
IYN System, Imaging, Pulsed Doppler, Ultrasonic
IYO System, Imaging, Pulsed Echo, Ultrasonic
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 17, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4544528100
info@bkultrasound.com
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