Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The focus is on standard ultrasound imaging technology and compliance with established medical device standards.

Therapeutic

No.
The system is explicitly described as a "diagnostic ultrasound imaging system" and its main function is to "acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes," which points to diagnosis rather than therapy.

Diagnostic

Yes

Explanation: The 'Intended Use / Indications for Use' states, "The system is a diagnostic ultrasound imaging system..." and the 'Device Description' also states, "The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System..."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System" and mentions various hardware components like transducers (Linear Array, Phased Linear Array, Convex / Curved Array) and their interaction with patients (Surface Contact, Intra-operative, Laparoscopic, or Endocavity). It also details testing for hardware-related standards like electrical safety, biocompatibility, and reprocessing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. This device is a diagnostic ultrasound system that uses sound waves to create images of structures within the human body. It does not involve the analysis of blood, urine, tissue, or other bodily fluids or substances outside the body.
The intended use and device description clearly state it's an ultrasound imaging system. The focus is on generating images and analyzing fluid flow in vivo, not on analyzing samples in vitro.
The listed clinical applications are all related to imaging internal structures. Obstetrics, abdominal, cardiac, etc., are all areas where ultrasound is used for imaging and guidance within the patient.

Therefore, this device falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types including Obstetrics), Abdominal. Pediatric. Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:
The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

The Cardiac Adult application is not intended for direct use on the heart.

Product codes

IYN, IYO, ITX

Device Description

The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.
The transducers are all multi-frequency transducers including:

Linear Array
Phased Linear Array
Convex / Curved Array

The interaction with the patients is dependent upon the transducer type which may be:

. Surface Contact.
. Intra-operative,
Laparoscopic, or
Endocavity

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative (carotids, central blood vessels, aorta, vena cava, liver, biliary, pancreas, spleen, gallbladder, kidney, stomach), Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts - testicles, thyroid, breast, penis, parathyroid, salivary glands, lymph nodes, superficial anatomy), Adult Cephalic (also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac), Peripheral Vessel (also known as Peripheral Vascular).

Specific to 9076 (113C3f) transducer: Intra-operative: Liver, Biliary, Pancreas, Kidney, Stomach, Uterus.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified and trained healthcare professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance bench testing was performed. The Ultrasound Scanner System bk2300 fulfilled the requirements of FDA consensus standards and requirements set forth in the FDA guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Scanner System s and Transducers" issued on September 9, 2008 as it pertains to Track 3 devices. The results of these tests demonstrate that the proposed device performs as intended and were found acceptable to support the claim of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Ultrasound Scanner System bk2300 – K161960

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

August 1st, 2018

BK Medical ApS % Ms. Susana Mogensen Regulatory Affairs Manager Mileparken 34 Herlev 2730 DENMARK

Re: K180737

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: June 20, 2018 Received: June 25, 2018

Dear Ms. Mogensen:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Bafges

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

2

Indications for Use

510(k) Number (if known) K180737

Device Name

Ultrasound Scanner System bk2300

Indications for Use (Describe)

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types including Obstetrics), Abdominal. Pediatric. Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

The Cardiac Adult application is not intended for direct use on the heart.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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"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."

FORM FDA 3881 (7/17)

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Image /page/3/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features a green circle with a white sine wave inside, followed by the green text "bk ultrasound". Below the text is the phrase "powered by analogic" in a smaller, gray font, accompanied by a gray circle with a white sine wave inside.

System: BK2300

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | CWD 4) | Tissue
Harmonic
Imaging | CHI 5) | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined

| Other |
|------------------------------------------------------|---|---|-----|--------|-------------------------------|--------|------------------|----------------------|------------------------------|----------------|----------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | | P | P 3) |
| Abdominal | P | P | P | P | P | P | P | P | | P | P 3) |
| Intra-operative (Specify) 6) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-operative (Neuro) | P | P | P | | P | P | P | P | | P | P 3) |
| Laparoscopic | P | P | P | | P | P | P | P | | P | P 3) |
| Pediatric | P | P | P | | P | P | P | P | | P | P 3) |
| Small Organ (Specify) 7) | P | P | P | | P | P | P | P | | P | P 3) |
| Neonatal Cephalic | P | P | P | | P | P | P | P | | P | P 3) |
| Adult Cephalic | P | P | P | P | P | P | P | P | | P | P 3) |
| Trans-rectal | P | P | P | | P | P | P | P | | P | P 3) |
| Trans-vaginal | P | P | P | | P | P | P | P | | P | P 3) |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | | P | P | P | P | | P | P 3) |
| Musculo-skel. (Superficial) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | P | | P | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | | P | P | P | P | | P | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 2), 3) |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Vector Flow Imaging (VFI)

1. Elastography

Continuous Wave Doppler (CWD/CW)
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)
Intra-operative: carotids, central blood vessels, aorta, vena cava, liver, biliary, pancreas, spleen, gallbladder, kidney, stomach
Small organ: testicles, thyroid, breast, penis, parathyroid, salivary glands, lymph nodes, superficial anatomy

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

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Image /page/4/Picture/0 description: The image is a logo for BK Ultrasound. The logo consists of a green circle with a white wave inside, followed by the green text "bk ultrasound". Below the text is the phrase "powered by analogic" in a smaller font, followed by a gray circle with a white wave inside.

System: BK2300

Transducer: 9002 (9C2)

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	Tissue
Harmonic
Imaging	CHI	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | P | P | P | | P 2) |
| Fetal | P | P | P | | P | | P | P | | P | P 2) |
| Abdominal | P | P | P | | P | | P | P | | P | P 2) |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | | P | P 2) |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | | P | | P | P | | P | P 2) |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | | P | P | | P | P 2) |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Elastography

(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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Image /page/5/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in gray with a gray analogic logo.

System: BK2300

Transducer: 9009 (X18L5s)

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	Tissue
Harmonic
Imaging	CHI	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) 3) | P | P | P | | | | P | P | | P | P 2) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) 4) | P | P | P | | | | P | P | | P | P 2) |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | P | P | P | | | | P | P | | P | P 2) |
| Musculoskeletal. (Superficial) | P | P | P | | | | P | P | | P | P 2) |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult) | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | | | P | P | | P | P 2) |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:
B+M, B+D, B+C, B+D+C. (B, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
1. Elastography
1. Intra-operative: carotids, central blood vessels, aorta, vena cava
Small Organ: testicles 4)

(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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Image /page/6/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in smaller gray font below it, along with a gray circle containing a white wave-like design.

System: BK2300

Transducer: 9011 (13L4w)

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

| Clinical Application
Specific

(Tracks I & III)	Modes
	B	M	PWD	CWD	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric	P	P	P	P	P	P	P	P	P 3)
Small Organ (Specify) 2)	P	P	P	P	P	P	P	P	P 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)	P	P	P	P	P	P	P	P	P 3)
Musculo-skel. (Superficial)	P	P	P	P	P	P	P	P	P 3)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel	P	P	P	P	P	P	P	P	P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Small Organ: thyroid, breast, testes, penis, parathyroid, salivary glands, lymph nodes.
Elastography

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

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Image /page/7/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in gray with the analogic logo.

System: BK2300

Transducer: 9015 (114C5I)

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	Tissue
Harmonic
Imaging	CHI 4)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) 3) | P | P | P | | P | P | P | P | | P | P 2) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | P | P 2) |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:
  B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
1. Elastography
1. Intra-operative: Liver, Biliary, Pancreas, Spleen, Gallbladder, Kidney, Stomach, Breast
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)

(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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Image /page/8/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font.

System: BK2300

Transducer: 9016 (114C5T)

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	Tissue
Harmonic
Imaging	CHI 4)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | P | | P | P 2) |
| Intra-operative Specify) 3) | P | P | P | | P | P | P | P | | P | P 2) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations: 1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
1. Elastography
1. Inter-operative: Liver, Biliary, Pancreas, Kidney
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)

(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

Image /page/9/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white sine wave inside.

System: BK2300

Transducer: 9018 (E14C4t)

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

| Clinical Application
Specific

(Tracks I & III)	Modes
	B	M	PWD	CWD	Tissue
Harmonic
Imaging	Contrast
Harmonic
Imaging 3)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | | |
| Adult Cephalic) | | | | | | | | | | | | |
| Trans-rectal | P | P | P | | P | P | P | P | | P | P 2) | |
| Trans-vaginal | P | P | P | | P | P | P | P | | P | P 2) | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Cardiac Adult) | | | | | | | | | | | | |
| Cardiac Pediatric) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Peripheral vessel) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Elastography
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 3)

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

10

Image /page/10/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green sans-serif font. Below the word "ultrasound" is the text "powered by analogic" in a smaller, gray sans-serif font, accompanied by a gray circle with a white sine wave inside.

System: BK2300

Transducer: 9019 (E10C4)

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	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify 1)	Other
Ophthalmic
Fetal	P	P	P	P	P	P	P	P	P	P 2)
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P	P	P	P	P	P	P	P 2)
Trans-vaginal	P	P	P	P	P	P	P	P	P	P 2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Elastography

(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

Image /page/11/Picture/0 description: The image is a logo for BK Ultrasound. The logo features a green sphere with a white sine wave inside of it, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in gray, followed by a gray circle with a white "A" inside of it.

System: BK2300

Transducer: 9022 (10L2w)

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

| Clinical Application
Specific

(Tracks I & III)	Modes
	B	M	PWD	CWD	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel	P	P	P		P	P	P	P	P 2),3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Elastography

Vector Flow Imaging (VFI) 3)

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

12

Image /page/12/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller, gray font, accompanied by a gray circle containing a stylized "A".

System: BK2300

Transducer: 9023 (6C2s)

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	Tissue
Harmonic
Imaging	CHI 3)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | | P | P 2) |
| Abdominal | P | P | P | | P | P | P | P | | P | P 2) |
| Intra-operative Specify | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | P | P 2) |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations: 1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
1. Elastography
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

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

13

Image /page/13/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in gray, accompanied by a gray circle with a white "A" inside.

System: BK2300

Transducer: 9024 (112C5b)

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	Tissue
Harmonic
Imaging	CHI 4)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative Specify 2) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | P | P | P | | P | P | P | P | | P | P 3) |
| Musculoskeletal. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 3) |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations: 1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
1. Intra-operative: Liver, Biliary, Pancreas, Kidney
1. Elastography
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)

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

14

Image /page/14/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like line running through it, followed by the text "bk ultrasound" in green. Below the text, in a smaller font, is the phrase "powered by analogic" with the analogic logo.

System: BK2300

Transducer: 9026 (X12C4)

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	Tissue
Harmonic
Imaging	CHI 4)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative Specify 2) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

1. Mode combinations:
  B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
1. Intra-operative: Pancreas, Kidney, Liver
Elastography 3)
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)

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

15

Image /page/15/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white "A" inside.

System: bk2300

Transducer: 9027 (T7P2m)

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 2)	Tissue
Harmonic
Imaging	CHI 3)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. Cardiac | P | P | P | P | P | P | P | P | P | P | |
| Peripheral vessel) | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Continuous Wave Doppler (CWD/CW)
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

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

16

Image /page/16/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in gray below it. The logo is simple and modern, and the use of green gives it a sense of health and technology.

System: BK2300

Transducer: 9029 (E13C2)

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 2)	Tissue
Harmonic
Imaging	CHI 3)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | E | E | E | | E | E | E | E | | E | E 2) |
| Trans-vaginal | E | E | E | | E | E | E | E | | E | E 2) |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. Cardiac | | | | | | | | | | | |
| Peripheral vessel) | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E (LTF: 10.13.2016)

Additional Comments:

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

Elastography

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 (OIR)

17

Image /page/17/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller, gray font, accompanied by a gray circle with a white design.

System: BK2300

Transducer: 9032 (8L2)

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	Tissue
Harmonic
Imaging	CHI 4)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | P | P 3) | |
| Small Organ (Specify 2) | P | P | P | | P | P | P | P | | P | P 3) | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculoskeletal (Conventional) | P | P | P | | P | P | P | P | | P | P 3) | |
| Musculoskeletal. (Superficial) | P | P | P | | P | P | P | P | | P | P 3) | |
| Intra-luminal | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 3), 5) | |
| Other (Specify) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations: 1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
1. Small Organ: Thyroid, Breast, Testes
1. Elastography
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)
1. Vector Flow Imaging (VFI)

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

18

Image /page/18/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the green text "bk ultrasound". Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white wave-like design inside.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: BK2300

Transducer: 9038 (X14L4)

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	Tissue
Harmonic
Imaging	CHI 2)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | E | E | E | | E | E | E | E | | E | E 3) |
| Trans-vaginal | E | E | E | | E | E | E | E | | E | E 3) |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E (LTF 10.09.2017)

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

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 (OIR)

19

Image /page/19/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the green letters "bk" and the word "ultrasound" in green. Below "bk ultrasound" is the phrase "powered by analogic" in a smaller font, along with a gray circle containing the letter A.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: BK2300

Transducer: 9040 (6C2)

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	Tissue
Harmonic
Imaging	CHI	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | P | P | P 2) | |
| Abdominal | P | P | P | | P | P | P | P | P | P | P 2) | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | P | P | P | | P | P | P | P | | P | P 2) | |
| Musculoskeletal. (Superficial) | P | P | P | | P | P | P | P | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)
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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/20/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" with a gray circle containing a white "A" logo.

System: BK2300

Transducer: 9048 (E14CL4b)

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	Tissue Harmonic Imaging	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	P	P		P	P 2), 3)
Trans-vaginal	P	P	P		P	P	P		P	P 2), 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Elastography
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

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

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Image /page/21/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, followed by a gray circle with a white "A" inside.

System: BK2300

Transducer: 9051 (14L3)

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	Tissue
Harmonic
Imaging	Contrast
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | | P | P 3) |
| Small Organ (Specify) 4) | P | P | P | | P | | P | P | | P | P 3) |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | P | P | P | | P | | P | P | | P | P 3) |
| Musculoskeletal. (Superficial) | P | P | P | | P | | P | P | | P | P 3) |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | | P | P | | P | P 2) 3) |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Vector Flow Imaging (VFI)

1. Elastography
1. Small Organ: breast, thyroid, testes

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

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Image /page/22/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text, it says "powered by analogic" in gray, accompanied by a gray circle with a white sine wave inside.

System: BK2300

Transducer: 9052 (20R3)

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | CWD | Tissue
Harmonic
Imaging | CHI | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined

| Other |
|------------------------------------------------------|---|---|-----|-----|-------------------------------|-----|------------------|----------------------|------------------------------|----------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | P | | | | | | | | | | |
| Trans-vaginal | P | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

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

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Image /page/23/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the word "ultrasound" is the text "powered by analogic" in gray, along with a gray circle containing a white sine wave.

System: BK2300

Transducer: 9062 (N13C5)

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	Tissue
Harmonic
Imaging	Contrast
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify) 3)	P	P	P	P	P	P	P	P	P 2)
Intra-operative (Neuro)	P	P	P	P	P	P	P	P	P 2)
Laparoscopic
Pediatric	P	P	P		P	P	P	P	P 2)
Small Organ (Specify)
Neonatal Cephalic	P	P	P		P	P	P	P	P 2)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Cardiac Adult)
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Intra-operative: gallbladder 3)

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Image /page/24/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the text "bk ultrasound" in green. Below the text, it says "powered by analogic" in a smaller font, accompanied by a gray circle with a white design.

System: BK2300

Transducer: 9063 (N11C5s)

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	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative Specify 2)	P	P	P		P	P	P	P
Intra-operative (Neuro)	P	P	P		P	P	P	P
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Intra-operative: Gall Bladder

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Image /page/25/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white "A" inside.

System: BK2300

Transducer: 9066 (112C4f)

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	Tissue
Harmonic
Imaging	CHI 3)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)2)	P	P	P	P	P	P	P	P	P 4)
Intra-operative (Neuro)
Laparoscopic	E	E	E	E	E	E	E	E	P 4)
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E (LTF: 05.24.2017)

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Intra-operative: Laparoscopic procedure for abdominal region, Liver, Biliary, Pancreas, Kidney, Stomach, Uterus
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)
1. Elastography

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Image /page/26/Picture/0 description: The image is a logo for BK Ultrasound. The logo is green and features a stylized "A" inside of a green circle. To the right of the circle are the letters "bk" in green, followed by the word "ultrasound" in green. Below the word "bk" is the phrase "powered by analogic" in a smaller font, followed by a stylized "A" inside of a gray circle.

System: BK2300

Transducer: 9067 (E14C4)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	CWD	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal	P	P	P		P	P	P	P	P 2)
Trans-vaginal	P	P	P		P	P	P	P	P 2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

Elastography

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Image /page/27/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white "A" inside.

System: BK2300

Transducer: 9070 (18L5)

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	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify) 2)	P	P	P		P	P	P	P	P 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)	P	P	P		P	P	P	P	P 3)
Musculoskeletal. (Superficial)	P	P	P		P	P	P	P	P 3)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel)	P	P	P		P	P	P	P	P 3)
Other (Specify)

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Small Organ: thyroid, breast, testes, superficial anatomy

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Image /page/28/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white waveform inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in gray, accompanied by a gray circle with a white waveform inside.

System: BK23000

Transducer: 9076 (113C3f)

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

Clinical Application	Modes
Specific	B	M	PWD	CWD	Tissue	CHI 3)	Color	Amplitude	Color	Combined	Other
(Tracks I & III)					Harmonic		Doppler	Doppler	Velocity	1)
					Imaging				Imaging
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify 2)	N	N	N	N	N	N	N	N	N	N	N 4)
Intra-operative (Neuro)
Laparoscopic	N	N	N	N	N	N	N	N	N	N	N 4)
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

Mode combinations:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Intra-operative: Liver, Biliary, Pancreas, Kidney, Stomach, Uterus
1. Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)
1. Elastography

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Image /page/29/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in gray with the analogic logo.

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

System: BK2300

Transducer: 9077 (5P1)

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

| Tissue
Harmonic
Imaging | Contrast
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
| Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | | P | P | P | P | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | | P | P | P | P | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult 3) | P | P | P | P | P | | P | P | | P | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Continuous Wave Doppler (CWD/CW)
1. Adult Cardiac: Not for direct use on the heart

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Image /page/30/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the green text "bk ultrasound". Below the text is the phrase "powered by analogic" in a smaller font, followed by a gray circle with a white sine wave inside.

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

System: BK2300

Transducer: 9081 (18L5s)

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | CWD | Modes
Tissue
Harmonic
Imaging | Contrast
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined 1) | Other |
|------------------------------------------------------|---|---|-----|-----|----------------------------------------|---------------------------------|------------------|----------------------|------------------------------|-------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | E | E | E | E | E | E | E | E | E | E | E 3) |
| Small Organ (Specify 2) | E | E | E | E | E | E | E | E | E | E | E 3) |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | E | E | E | E | E | E | E | E | E | E | E 3) |
| Musculo-skel. (Superficial) | E | E | E | E | E | E | E | E | E | E | E 3) |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | E | E | E | E | E | E | E | E | E | E | E 3) |
| Other (Specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E (LTF:10.10.2016)

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)

1. Small organ: breast, thyroids, testes
  Elastography 3)

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Image /page/31/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave design inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white "A" inside.

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

System: BK2300

Transducer: 9085 (5Cle)

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	Tissue
Harmonic
Imaging	Contrast
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined 1)	Other
Ophthalmic
Fetal	E	E	E		E	E	E	E	E	E 2)
Abdominal	E	E	E		E	E	E	E	E	E 2)
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Specify 2)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)	E	E	E		E	E	E	E	E	E 2)
Musculo-skel. (Superficial)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E (LTF:10.13.2016)

Additional Comments:

B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including 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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Image /page/32/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white line running through it, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white line running through it.

5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

l. BK Medical ApS Submitter: Mileparken 34 Herlev 2730 Denmark
Tel: +45-44-52-8105 Fax: (978) 977-6808 Contact: Susana Mogensen Regulatory Affairs Manager E-mail: smogensen@bkultrasound.com

Date Prepared: July 24, 2018

II. Device Names / Common Names / Classification Names:

Trade Name:	Ultrasound Scanner System bk2300
Common Name:	Ultrasound Scanner System
Classification Name:	Ultrasonic pulsed doppler imaging system
Product Code:	IYN, IYO, ITX
Class:	II
Regulation Number:	21 CFR §892.1550, §892.1560, §892.1570
Classification Panel:	Radiology

III. Identification of Predicate or Legally Marketed Devices:

Ultrasound Scanner System bk2300 – K161960 (10/17/2016)

IV. Device Description:

The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic Ultrasound Scanner System with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

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The transducers are all multi-frequency transducers including:

Linear Array
Phased Linear Array ●
Convex / Curved Array ●

The interaction with the patients is dependent upon the transducer type which may be:

. Surface Contact.
. Intra-operative,
Laparoscopic, or
Endocavity

The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.

V. Indications / Intended Use:

The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The Ultrasound Scanner System bk2300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

The Cardiac Adult application is not intended for direct use on the heart.

VL. Comparison of Technological Characteristics with the Predicate Device:

| Item | Ultrasound Scanner System
bk2300 | Ultrasound Scanner System
bk2300 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (predicate device) | (proposed device) |
| Modes of
operation | B, M, PWD, CFM* and
combinations, Tissue Harmonic
Imaging, Vector Flow Analysis,
Continuous Wave Doppler
(CWD), Elastography, Contrast
Imaging | B, M, PWD, CFM* and
combinations, Tissue Harmonic
Imaging, Vector Flow Analysis,
Continuous Wave Doppler (CWD),
Elastography, Contrast Imaging |
| Item | Ultrasound Scanner System
bk2300 | Ultrasound Scanner System
bk2300 |
| | (predicate device) | (proposed device) |
| Intended Use | The system is a diagnostic
ultrasound imaging system used by
qualified and trained healthcare
professionals for ultrasound
imaging, human body fluid flow
analysis and puncture and biopsy
guidance. | The system is a diagnostic
ultrasound imaging system used by
qualified and trained healthcare
professionals for ultrasound
imaging, human body fluid flow
analysis and puncture and biopsy
guidance. |
| Clinical
Applications | Fetal (including Obstetrics),
Abdominal, Pediatric, Intra-
operative, Intra-operative Neuro
(also known as Neurosurgery),
Laparoscopic, Small Organ (also
known as Small Parts), Adult
Cephalic (cephalic is also known
as Adult Trans-cranial), Neonatal
Cephalic, Trans-rectal, Trans-
vaginal, Musculo-skeletal
(Conventional and Superficial),
Cardiac Adult, Trans-esophageal
(Cardiac) and Peripheral Vessel
(also known as Peripheral
Vascular). | Fetal (including Obstetrics),
Abdominal, Pediatric, Intra-
operative, Intra-operative Neuro
(also known as Neurosurgery),
Laparoscopic, Small Organ (also
known as Small Parts), Adult
Cephalic (cephalic is also known as
Adult Trans-cranial), Neonatal
Cephalic, Trans-rectal, Trans-
vaginal, Musculo-skeletal
(Conventional and Superficial),
Cardiac Adult, Trans-esophageal
(Cardiac) and Peripheral Vessel
(also known as Peripheral
Vascular). |
| Transducers | 9002, 9009, 9011, 9015, 9016,
9018, 9019, 9022, 9023, 9024,
9026, 9029, 9032, 9038, 9040,
9048, 9051, 9052, 9062, 9063,
9066, 9067, 9070, 9077, 9081,
9085 | 9002, 9009, 9011, 9015, 9016,
9018, 9019, 9022, 9023, 9024,
9026, 9029, 9032, 9038, 9040,
9048, 9051, 9052, 9062, 9063,
9066, 9067, 9070, 9077, 9081,
9085
New transducers:
9076 |
| Features | ECG (not monitoring) | ECG (not monitoring) |
| Features | Wi-Fi | Wi-Fi |
| Special Features | | Laser pointer for guidance of
needles: Class 2 Laser product. |

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

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Performance Data: VII.

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical /Performance - Bench Testing:

Bench testing was performed and the Ultrasound Scanner System bk2300 fulfilled the requirements of the following FDA consensus standards and requirements set forth in FDA guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Scanner System s and Transducers" issued on September 9, 2008 as it pertains to Track 3 devices:

IEC 60601-2-37 - Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment

IEC 62359 - Ultrasonics - Field Characterization - Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields

NEMA UD 2 - Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3

IEC 62366-1 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices

IEC 60825-1 - safety of laser products - part 1: equipment classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 2 (2007)].

Testing to the above-mentioned standards was performed on the proposed Ultrasound Scanner System bk2300. The results of these tests demonstrate that the proposed device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

Biocompatibility:

The main Ultrasound Scanner System bk2300 console is not patient contacting. However, the transducers are patient contacting and categorized per Section 5.2 and Table A1 of AAMI/ANSI/ISO 10993-1 according to their clinical use. The transducers comply with the applicable biocompatibility standard requirements.

Sterilization:

The Ultrasound Scanner System bk2300 is not sold as a sterile device. The transducers require reprocessing prior to use. Testing to support recommended methods for reprocessing was performed in accordance with TIR-12 and TIR-30.

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Electrical Safety & Electromagnetic Compatibility (EMC):

Electrical safety testing is compliant with the following standards:

AAMI/ANSVES 60601-1: 2005/( R ) 2012 and A1:2012. C1:2009/( R ) 2012 and ● A2:2010/ ( R ) 2012 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2 Edition 3: 2007-03 medical electrical equipment part 1-2: general . requirements for basic safety and essential performance

Laser Verification and Validation Testing:

Safety of laser products testing is compliant with the following standards:

IEC 60825-1 Edition 2.0 2007-03, safety of laser products part 1: equipment . classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. The Ultrasound Scanner System bk2300 complies with EN IEC 62304. Medical Device Software Life-Cycle Processes. The submission contains performance data which demonstrates conformance to special controls for medical devices containing software.

Animal Testing:

Not applicable - animal testing was not required to support substantial equivalence to the predicate device.

Clinical Studies:

Not applicable - clinical studies were not required to support substantial equivalence to the predicate device.

VIII. Conclusion:

The proposed Ultrasound Scanner System bk2300 is substantially equivalent to the predicate Ultrasound Scanner System bk2300 (K161960). The differences between the proposed and predicate device do not impact the safety and effectiveness of the proposed device. Performance testing supports that the proposed device is substantially equivalent to the legally marketed predicate device.