DEVICE: Pro Focus Ultraview Ultrasound System (05704916001032)

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Device Identifier (DI) Information

Pro Focus Ultraview Ultrasound System
2202

Bk Medical ApS
05704916001032
GS1
1
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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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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