Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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. And 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.

Device Description

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. And 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.

AI/ML Overview

This is a 510(k) premarket notification for the BK Medical Ultrasound Scanner System bk2300, which is an ultrasound device. The information provided is typical for a 510(k) submission, focusing on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific clinical study results for novel performance claims.

Based on the provided document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to safety and performance specifications that demonstrate equivalence to predicate devices, rather than specific diagnostic accuracy metrics for AI. Since this is an ultrasound system, the performance is about its various imaging modes, clinical applications, and safety.

Acceptance Criteria (General for Ultrasound Systems)	Reported Device Performance (bk2300)
Acoustic Output Limits	The system assures acoustic output stays below pre-amendments upper limits: Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non-ophthalmic). Thermal Index values are maximum 6.0 (TI ≤ 6.0).
Electrical, Thermal, Mechanical Safety	Device tested to conform with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, IEC 62304, IEC 62359. "Safety is unchanged."
Biocompatibility	All patient contact materials are biocompatible, tested to EN ISO 10993-1. "Biocompatibility is unchanged."
Clinical Measurement Accuracy	"Clinical measurements and calculations are described and accuracies are provided in the User Information." (No specific metrics provided in this document, but implies that accuracy is satisfactory and documented). ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Equivalence to Predicate Device (bk2300, K143298)	The modified device maintains the same modes of operation (B, THI, M, PWD, CFM, CHI, CWD, VFI, Elastography, and combinations) and indications for use as the predicate device (Fetal, Abdominal, Intraoperative, Neurosurgery, Pediatrics, Small Parts, Adult Cephalic, Neonatal Cephalic, Transrectal, Transvaginal, Transurethral, Musculoskeletal, Cardiac, Peripheral Vessel). Minor differences include an optional RF wireless function.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly describe a "test set" in the context of a clinical performance study using patient data for specific diagnostic claims for AI. For an ultrasound system, "testing" primarily refers to technical verification and validation, and acoustic output measurements.

The section on Acoustic Output Reporting states it's "made according to the standards required by 'Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008'". These standards define measurement procedures and reporting requirements, but not a patient-based test set size.
The document also notes that "All transducers in this submission have previous been cleared," simplifying the current submission to changes to the system rather than the transducers themselves.
Data Provenance: Not applicable in the context of a clinical test set for AI, as this submission focuses on the safety and functional equivalence of an ultrasound system, not AI performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This FDA 510(k) submission is for a general diagnostic ultrasound system (bk2300) and its various transducers. It does not describe an AI/CADe (Computer-Aided Detection/Diagnosis) system that requires expert-established ground truth on a clinical test set. The "performance" claims are about physical parameters and safety limits, not diagnostic accuracy in interpreting images.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical test set for diagnostic performance evaluation or AI, no adjudication method would have been used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This submission is for an ultrasound imaging system, not an AI or CADe product. MRMC studies are typically used for evaluating the effectiveness of AI/CADe systems in improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm being submitted for standalone performance evaluation. It is a diagnostic ultrasound system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance claims (e.g., acoustic output, electrical safety, biocompatibility, measurement capabilities) is established through adherence to recognized national and international standards (e.g., IEC, ISO, AIUM/NEMA standards) and technical specifications. It's not clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy for AI.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe an AI system, therefore, there is no training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm or training set, this information is not relevant to this submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical technical verification and validation study. This involves:

Acoustic Output Measurements: The system controlling acoustic output (same as predicate Pro Focus 2202) was verified to ensure that the device's acoustic output remains below regulatory limits (Ispta ≤ 720 mW/cm² and MI ≤ 1.9, TI ≤ 6.0). This is done through standard phantom and hydrophone measurements as per AIUM/NEMA UD-2 and UD-3.
Safety Testing: The device was tested by a recognized Certified Body to confirm compliance with a comprehensive set of safety standards, including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment specific safety), ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62359 (field characterization). These tests ensure thermal, mechanical, and electrical safety, as well as software integrity.
Biocompatibility Testing: Patient contact materials were assessed for biocompatibility according to EN ISO 10993-1.
Clinical Measurements and Calculations: The accuracy of clinical measurements and calculations is stated to be "described and accuracies are provided in the User Information," indicating that these were verified against established performance benchmarks, although specific metrics are not in the 510(k) summary itself.
Technological Equivalence Comparison: The core of the 510(k) submission relies on demonstrating that the bk2300 system, including its new optional RF wireless function and the addition of Elastography (for some transducers compared to the oldest reference device, though it's present in the direct predicate), has "the same major technological characteristics" and intended use as the previously cleared predicate device (bk2300, K143298) or the reference device (ProFocus 2202, K132346). This comparison inherently "proves" that the device meets acceptance criteria by establishing its substantial equivalence to a device already deemed safe and effective by the FDA.

In essence, the "study" is a collection of engineering and regulatory compliance tests rather than a clinical trial assessing diagnostic performance.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 5. 2015

BK Medical ApS % Mrs. Randi Hauerberg Regulatory Affairs Lead Manager Mileparken 34 DK-2730 Herlev DENMARK

Re: K151910 Trade/Device Name: Ultrasound Scanner System bk2300

Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 10, 2015 Received: September 21, 2015

Dear Mrs. Hauerberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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ALTHAND HUMAN SERVICES

510(k) Number (if known)

K151910

Device Name

Ultrasound Scanner System bk2300

Indications for Use (Describe)

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. And 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.

Clinical Applications:

Fetal (Sometimes called Obstetrics) ●
Abdominal ●
Intra-operative ●
Intra-operative (Neuro) (sometimes called Neuro Surgical)
Pediatrics
Small Organ (Sometimes called Small Parts)
. Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
Adult Cephalic (Cephalic is sometimes called trans-cranial) ●
Trans-rectal
Trans-vaqinal
Trans-urethral
Musculo-skeletal (Conventional) ●
Musculo-skeletal (Superficial) ●
Cardiac Adult ●
Peripheral Vessel (Sometimes called Peripheral Vascular) .

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Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Suppart C)

PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Certer for Devices and Radiclogical Health (CDRH] (Signature)

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This section applies only to requirements of the Paperwork Recuetion Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per resporse. Including the time to review instructions, search existing data sources, gather and maintain the dista needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burder, to:

Department of Hoalth and Human Services Food and Drug Administration Office of Chief Intormation Officer Paperwork Reduction Act (PRA) Staff PRAStaff@ida.hhs.gov

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number

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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Modes
Specific	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
(Tracks I & III)
Ophthalmic
Fetal 2)	P	P	P	N	P	N	P	P	P	P	N 25)
Abdominal 3)	P	P	P	N	P	N	P	P	P	P	N 25)
Intra-operative (Specify 4)	P	P	P	N	P	N	P	P	P	P	N 25)
Intra-operative (Neuro 5)	P	P	P	N	P	N	P	P	P	P	N 25)
Laparoscopic 6)
Pediatric 7)	P	P	P	N	P	N	P	P	P	P	N 25)
Small Organ (Specify 8)	P	P	P	N	P	N	P	P	P	P	N 25)
Neonatal Cephalic 9)	P	P	P	N	P	N	P	P	P	P	N 25)
Adult Cephalic 10)	P	P	P	N	P	N	P	P	P	P	N 25)
Trans-rectal 11)	P	P	P	N	P	N	P	P	P	P	N 25)
Trans-vaginal 12)	P	P	P	N	P	N	P	P	P	P	N 25)
Trans-urethral 13)	P	P	P	N	P	N	P	P	P	P	N 25)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	P	P	P	N	P	N	P	P	P	P	N 25)
Musculo-skel. (Superficial 16)	P	P	P	N	P	N	P	P	P	P	N 25)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)	P	P	P	N	P	N	P	P	P	P	N 25)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	P	P	P	N	P	N	P	P	P	P	N 24N 25)
Other (Specify 24)											N
Other (Specify 25)											N)

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, Color Velocity Imaging. Tissue Harmonic Imaging.

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2. Please do observe that the numbering of the comments from 1 to 27 are fixed to make the document more consistent meaning that comment 1 is provided here below and the rest of the comments are provided in the attachment 2 if relevant.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

1. Vector Flow Imaging (VFI)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

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Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9002

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)	E	E	E	E	E	E	E	E	E	E	E 25)
Abdominal 3)	E	E	E	E	E	E	E	E	E	E	E 25)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	E	E	E	E	E	E	E	E	E	E	E 25)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	E	E	E	E	E	E	E	E	E	E	E 25)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	E	E	E	E	E	E	E	E	E	E	E 25)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Please do observe that the numbering of the comments from 1 to 27 are fixed to make the document more consistent meaning that comment 1 is provided here below and the rest of the comments are provided in the attachment 2 if relevant.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

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Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9011

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	E	E	E	E	E	E	E	E	E	E	E 25)
Small Organ (Specify 8)	E	E	E	E	E	E	E	E	E	E	E 25)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	E	E	E	E	E	E	E	E	E	E	E 25)
Musculo-skel. (Superficial 16)	E	E	E	E	E	E	E	E	E	E	E 25)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	E	E	E	E	E	E	E	E	E	E	E 25)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{8}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9015

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)	E	E	E	E	E	E	E	E	E 25)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	E	E	E	E	E	E	E	E	E 25)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)									P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{9}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9016

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)	E	E	E		E	E	E	E		E	E 25)
Intra-operative (Specify 4)	E	E	E		E	E	E	E		E	E 25)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{10}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9018

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Modes
Specific(Tracks I & III)	B	M	PWD	CWD26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)	P	P	P		P	E	P	P		P	N25)
Trans-vaginal 12)	P	P	P		P	E	P	P		P	N25)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											N

1. Vector Flow Imaging (VFI)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:
	B+M,
	B+D,
	B+C,
	B+D+C.
	B includes Tissue Harmonic Imaging
	D:PWD.
	C: Color Flow mapping Doppler incl.
	Amplitude(power)Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{11}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9019

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)	E	E	E		E		E	E		E	E 25)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)	E	E	E		E		E	E		E	E 25)
Trans-vaginal 12)	E	E	E		E		E	E		E	E 25)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.
		B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{12}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9022

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	E	E	E	E	E	E	E	E		E	E 24)E 25)
Other (Specify 24)											P
Other (Specify 25)											P

1. Vector Flow Imaging (VFI)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{13}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9023

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)	P	P	P		P	E	P	P		P	E 25)
Abdominal 3)	P	P	P		P	E	P	P		P	E 25)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	P	P	P		P	E	P	P		P	E 25)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,
		B+D,
		B+C,
		B+D+C.
		B includes Tissue Harmonic Imaging
		D:PWD.
		C: Color Flow mapping Doppler incl.
		Amplitude(power)Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{14}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9024

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)	E	E	E	E	E	E	E	E	E	E	E 25)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	E	E	E	E	E	E	E	E	E	E	E 25)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	E	E	E	E	E	E	E	E	E	E	E 25)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{15}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9026

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)	E	E	E	E	E	E	E	E		E	E 25)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{16}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9032

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	E	E	E	E	E	E	E	E	E	E	E 25)
Small Organ (Specify 8)	E	E	E	E	E	E	E	E	E	E	E 25)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	E	E	E	E	E	E	E	E	E	E	E 25)
Musculo-skel. (Superficial 16)	E	E	E	E	E	E	E	E	E	E	E 25)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	E	E	E	E	E	E	E	E	E	E	E 25)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{17}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9040

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
(Tracks I & III)
Ophthalmic
Fetal 2)	E	E	E	E	E	E	E	E		E
Abdominal 3)	E	E	E	E	E	E	E	E		E
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	E	E	E		E	E	E	E		E
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{18}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9048

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)	E	E	E		E	E	E	E		E	E 25)
Trans-vaginal 12)	E	E	E		E	E	E	E		E	E 25)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											P

1. Vector Flow Imaging (VFI)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

Additional Comments:

	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
--	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{19}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9051

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application						Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	P	P	P	P	P	P	P	P	P	P	N 25)
Small Organ (Specify 8)	P	P	P	P	P	P	P	P	P	P	N 25)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	P	P	P	P	P	P	P	P	P	P	N 25)
Musculo-skel. (Superficial 16)	P	P	P	P	P	P	P	P	P	P	N 25)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	P	P	P	P	P	P	P	P	P	P	N 24)N 25)
Other (Specify 24)											N
Other (Specify 25)											N

1. Vector Flow Imaging (VFI)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{20}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9052

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)	E
Trans-vaginal 12)	E
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{21}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9062

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationSpecific(Tracks I & III)	B	M	PWD	TissueHarmonicImaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)	P	P	P	P	P	P	P	P	N25)
Intra-operative (Neuro 5)	P	P	P	P	P	P	P	P	N25)
Laparoscopic 6)
Pediatric 7)	P	P	P	P	P	P	P	P	N25)
Small Organ (Specify 8)
Neonatal Cephalic 9)	P	P	P	P	P	P	P	P	N25)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)									N

1. Vector Flow Imaging (VFI)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

that comment 1 is provided here below and the rest of the comments are provided in the attachment 2 if relevant.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{22}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9063

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)	P	P	P		P	P	P	P		P
Intra-operative (Neuro 5)	P	P	P		P	P	P	P		P
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

{23}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

System: bk2300

Transducer: 9066

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined1)	Other
(Tracks I & III)
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)	E	E	E	E	E	E	E	E		E	E 25)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											P

Vector Flow Imaging (VFI) 24)
1. Elastography.
Continuous Wave Doppler (CWD/CW) 26)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

The numbering in the table above refers to comments and history provided, if considered relevant. Comment 1 is provide in the table below. The rest of the comments are provided in Attachment 2.

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{24}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9067

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)	P	P	P		P		P	P		P	E 25)
Trans-vaginal 12)	P	P	P		P		P	P		P	E 25)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)											P

1. Vector Flow Imaging (VFI)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 27)

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

{25}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9070

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)	P	P	P		P		P	P		P	E 25)
Small Organ (Specify 8)	P	P	P		P		P	P		P	E 25)
Neonatal Cephalic 9)
Adult Cephalic 10)
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)	P	P	P		P		P	P		P	E 25)
Musculo-skel. (Superficial 16)	P	P	P		P		P	P		P	E 25)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)	P	P	P		P		P	P		P	E 25)
Other (Specify 24)
Other (Specify 25)											P

1. Vector Flow Imaging (VFI)
1. Elastography.
1. Continuous Wave Doppler (CWD/CW)
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

that comment 1 is provided here below and the rest of the comments are provided in the attachment 2 if relevant.

Additional Comments:

1.	Mode combinations:
	B+M,
	B+D,
	B+C,
	B+D+C.
	B includes Tissue Harmonic Imaging
	D:PWD.
	C: Color Flow mapping Doppler incl.Amplitude(power)Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

System: bk2300

Transducer: 9077

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Modes
Specific(Tracks I & III)	B	M	PWD	CWD 26)	TissueHarmonicImaging	CHI 27)	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined 1)	Other
Ophthalmic
Fetal 2)
Abdominal 3)	P	P	P	N	P		P	P		P
Intra-operative (Specify 4)
Intra-operative (Neuro 5)
Laparoscopic 6)
Pediatric 7)
Small Organ (Specify 8)
Neonatal Cephalic 9)
Adult Cephalic 10)	P	P	P	N	P		P	P		P
Trans-rectal 11)
Trans-vaginal 12)
Trans-urethral 13)
Trans-esoph. (non-Card.) 14)
Musculo-skel. (Conventional 15)
Musculo-skel. (Superficial 16)
Intra-luminal 17)
Other (Specify 18)
Cardiac Adult 19)	P	P	P	N	P		P	P		P
Cardiac Pediatric 20)
Trans-esoph. (Cardiac 21)
Other (Specify 22)
Peripheral vessel 23)
Other (Specify 24)
Other (Specify 25)

1. Vector Flow Imaging (VFI).
1. Elastography.
1. Continuous Wave Doppler (CWD/CW).
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI).

Additional Comments:

1.	Mode combinations:	B+M,B+D,B+C,B+D+C.B includes Tissue Harmonic ImagingD:PWD.C: Color Flow mapping Doppler incl.Amplitude(power)Doppler
----	--------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

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510(k) Summary:

This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.

Submitters name: BK Medical Address: Mileparken 34, DK-2730 Herlev, Denmark Phone: +45 44528100 +45 44528199 Fax: Contact person: Randi Hauerberg, Regulatory Affairs Lead Manager Date prepared: July 28, 2015

Trade name: Ultrasound Scanner System bk 2300 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) Ultrasonic Pulsed Doppler Imaging System (90 IYN, CFR 892.1550) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)

Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner bk2300, K143298

Device description:

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.

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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Transducers

All the transducers in this submission have previous been cleared.

There are no changes to the physical design of the transducers There are no changes to the patient contact materials. All patient contact materials are biocompatible. All transducers used together with bk2300 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in the modified bk2300 is the same as the system in the predicate device Pro Focus 2202. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic).

The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0

Clinical measurement accuracy

Clinical measurements and calculations are described and accuracies are provided in the User Information.

Thermal, mechanical and electrical safety. The ultrasound scanner system bk2300 has been tested by a recognized Certified Body.

Acoustic Output Reporting

The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008"

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

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Summary of Technological Characteristics – Predicate Device Compared to Modified Device

Devices andPredicates	Predicate deviceK143298,Ultrasoundscanner bk2300	Reference deviceK132346,Ultrasoundscanner ProFocus2202	Modified device(this application),Ultrasoundscanner bk2300
Modes ofoperationRef.: [1]Appendix G	B	B	B
	THI	THI	THI
	M,	M,	M,
	PWD,	PWD,	PWD,
	CFM 1)	CFM 1)	CFM 1)
	and combinations	and combinations	and combinations
	CHI	CHI	CHI
	CWD,	CWD,	CWD,
	VFI	VFI	VFI
	Elastography		Elastography
Intended Use:	Diagnosticultrasound imagingor fluid flowanalysis of thehuman body asfollows:	Diagnosticultrasound imagingor fluid flowanalysis of thehuman body asfollows:	Diagnosticultrasound imagingor fluid flowanalysis of thehuman body asfollows:
Indications ForUse:	Fetal (inclObstetrics)	Fetal (inclObstetrics)	Fetal (inclObstetrics)
	Abdominal	Abdominal	Abdominal
	Intraoperative	Intraoperative	Intraoperative
	Neurosurgery	Neurosurgery	Neurosurgery
	Pediatrics	Pediatrics	Pediatrics
	Small Parts(organs)	Small Parts(organs)	Small Parts(organs)
	Adult Cephalic	Adult Cephalic	Adult Cephalic
	Neonatal Cephalic	Neonatal Cephalic	Neonatal Cephalic
	Transrectal	Transrectal	Transrectal
	Transvaginal	Transvaginal	Transvaginal
	Transurethral	Transurethral	Transurethral
	Muskulo-skeletal(conventional andsuperficial)	Muskulo-skeletal(conventional andsuperficial)	Muskulo-skeletal(conventional andsuperficial)
	Cardiac	Cardiac	Cardiac
	Peripheral Vessel	Peripheral Vessel	Peripheral Vessel
Features		ECG (notmonitoring)
Features		Wi-Fi	Wi-Fi

CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.

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A brief discussion of non-clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, thermal, electromagnetic and mechanical safety, biocompatibility and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

AIUM/NEMA UD-2, Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment
AIUM/NEMA UD-3, Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
IEC 60601-1, Medical Electrical Equipment, Part 1: General requirements for safety
IEC 60601-1-2, General requirements for safety, Collateral Standard, Electromagnetic Compatibility - Requirements and tests
IEC 60601-2-37, Particular requirements for the safety of ultrasonic diagnostic medical and ● monitoring equipment
ISO 14971, Application of Risk Management of Medical Devices
EN ISO 10993-1, Biocompatibility
IEC 62304, Medical Device Software - Software lifecycle processes
IEC 62359, Ultrasonics Field characterization Test methods for the determination of thermal ● and mechanical indices related to medical diagnostic ultrasonic fields

Thermal, electrical, electromagnetic, mechanical and biocompatibility safety is unchanged.

Technological characteristics compared to the predicate device

The predicate devices have the same major technological characteristics as the subject device described above.

Minor differences consist with respect to the Ultrasound Scanner System: Optional RF wireless function.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.