Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, neural networks, or any related terms. The performance studies focus on standard ultrasound device testing and software verification/validation, not AI/ML model training or evaluation.

Therapeutic

No
The device is described as a "diagnostic ultrasound imaging system" used for "ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance," and its clinical applications are listed. Its function is to "acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes." This indicates it is used for diagnosis, not treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" states, "The system is a diagnostic ultrasound imaging system..." and the "Device Description" also clearly indicates, "The Ultrasound System 1300 is a multi-purpose mobile, software controlled diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display" and includes various transducers (Phased Linear Array, Convex / Curved Array, Linear Array) which are hardware components essential for acquiring ultrasound data. The summary also mentions testing related to electrical safety, biocompatibility of transducers, and sterilization, all of which are associated with hardware. While software is a critical component ("software controlled"), the system is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the system is for "ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance." These are all procedures performed on the patient's body, not on samples taken from the body.
Device Description: The description details a diagnostic ultrasound system with transducers that interact directly with the patient (surface contact, intra-operative, endocavity). This aligns with in-vivo imaging, not in-vitro testing.
Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body. The focus is entirely on generating and interpreting ultrasound images of the internal structures and fluid flow within the patient.

IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic purposes. This device's function is to visualize the body directly using ultrasound technology.

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 include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult transcranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular).

Contraindications:

The Ultrasound System 1300 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 (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The Ultrasound System 1300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The initial release of the 1300 system will include the BK1500 marketing configuration model.

The transducers are all multi-frequency transducers including:

Phased Linear Array
Convex / Curved Array .
Linear Array. ●

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

Surface Contact, ●
Intra-operative, 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, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult trans-cranial), Neonatal Cephalic, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Trans-rectal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, and Peripheral Vessel (also known as Peripheral Vascular). Transvaginal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

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:

Bench testing was performed and the 1300 system fulfilled the requirements of the following FDA consensus standards and requirements set forth in FDA quidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems 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

Testing to the above-mentioned standards was performed on the proposed Ultrasound System 1300. 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 1300 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 System 1300 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.

Electrical Safety & Electromagnetic Compatibility (EMC):

Electrical safety testing is compliant with the following standards:

AAMI/ANSI/ES 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

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 System 1300 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.

Key results: The result of all conducted testing was found acceptable to support the claim of substantial equivalence. The proposed Ultrasound System 1300 is substantially equivalent to the predicate BK2300 Ultrasound Scanner (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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161960

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

February 23, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

BK Medical ApS % Ms. Karen Provencher Sr. Regulatory Affairs Specialist Mileparken 34 HERLEV. 2730 DENMARK

Re: K173569

Trade/Device Name: Ultrasound System 1300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 29, 2018 Received: January 30, 2018

Dear Ms. Provencher:

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 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Michael D. 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

2

Indications for Use

510(k) Number (if known) K173569

Device Name Ultrasound System 1300

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

Contraindications:

The Ultrasound System 1300 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/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 a smaller font, followed by a gray circle with a white design inside.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE

Ultrasound System: 1300

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 4)	Tissue
Harmonic
Imaging	CHI 5)	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined

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

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, breast
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 shows the logo for BK Ultrasound. The logo consists of a green sphere 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: 1300

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 | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | | P | P | | P | P 2) | |

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 (OlR)

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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 green letters "bk" and the word "ultrasound" in green. Below the word "ultrasound" is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9008 (E11C3b)

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

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)

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

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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 sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font size.

System: 1300

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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult) | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | | | P | P | | P | P 2) | |

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. (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
1. Small Organ: testicles

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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 sine wave inside, followed by the text "bk ultrasound" in green. Below the word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9011 (13L4w)

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | 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 3) |
| 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.) | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | P | P | P | | P | P 3) |
| Musculo-skel. (Superficial) | P | P | P | P | P | P | | P | P 3) |
| Intra-luminal | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| 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:

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)

8

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 text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font.

System: 1300

Transducer: 9015 (I14C5I)

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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |

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. Intra-operative: Liver, Biliary, Pancreas, Spleen, Gallbladder, Kidney, Stomach, Breast
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)

9

Image /page/9/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 is the phrase "powered by analogic" in a smaller, gray font, accompanied by a gray circular logo.

System: BK1300

Transducer: 9016 (I14C5T)

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 | P2) | |
| Intra-operative Specify) 3) | P | P | P | | P | P | P | P | | P | P2) | |
| 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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |

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. Inter-operative: Liver, Biliary, Pancreas, Kidney
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)

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 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.

System: 1300

Transducer: 9018 (E14C4t)

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	Contrast
Harmonic
Imaging	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 | P2),3) |
| Trans-vaginal | P | P | P | | P | | P | P | | P | P 2), 3) |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Cardiac Adult) | | | | | | | | | | | |
| Cardiac Pediatric) | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| 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)

(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)

11

Image /page/11/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 lowercase letters. Below the word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9019 (E10C4)

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | Tissue
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify 1) | Other |
|------------------------------------------------------|---|---|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|-------|
| Ophthalmic | | | | | | | | | |
| Fetal | 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 2) |
| Trans-vaginal | P | P | P | P | P | P | | P | P 2) |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | |
| Intra-luminal | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| 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

(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)

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 word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9022 (10L2w)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	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
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P	P	P	P	P	P	P 2), 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)

Elastography
Vector Flow Imaging (VFI)

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

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 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.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 1300

r

Transducer: 9023 (6C2s)

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

| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | Tissue
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | CHI 3) | Combined
(Specify 1) | 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.) | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | |
| Intra-luminal | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| 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
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) Prescription Use (Per 21 CFR 801.109)

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 sine wave inside, followed by the green letters "bk" and the word "ultrasound" in green. Below the word "ultrasound" is the phrase "powered by analogic" in a smaller font.

System: 1300

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 | P3) | |
| 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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 3) | |

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. Intra-operative: Liver, Biliary, Pancreas, Kidney
1. 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)

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 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: 1300

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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |

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: Pancreas, Kidney, Liver

Elastography 3)

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

16

Image /page/16/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 a smaller, lighter font.

System: 1300

Transducer: 9029 (E13C2)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	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	E	E	E	E	E	E	E	E	E 2), 3)
Trans-vaginal	E	E	E	E	E	E	E	E	E 2), 3)
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conv.)
Musculoskeletal (Superf.)
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:

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

3)Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

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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 sine wave inside, followed by the green letters "bk" in lowercase. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in smaller font below it.

System:1300

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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 3), 5) | |

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. Small Organ: Thyroid, Breast, Testes
1. Elastography

Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

1. Vector Flow Imaging (VFI)
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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)

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 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, along with a gray circle containing a white symbol.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 1300

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 | E 3) | |
| Trans-vaginal | E | E | E | E | E | E | E | E | | E | E 3) | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E: LTF October 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)
1. Elastography

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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 text "bk ultrasound" in green. Below the word "ultrasound" is the text "powered by analogic" in a smaller font.

System: 1300

Transducer: 9040 (6C2)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify 1)	Other
Ophthalmic
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
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
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
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)

Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

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

20

Image /page/20/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.

System: 1300

Transducer: 9048 (E14CL4b)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	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
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
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
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)

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

21

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 lowercase letters. Below the text, it says "powered by analogic" in smaller, gray letters.

System: 1300

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 1)	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
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel	P	P	P		P	P	P	P	P 2)
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)

1. 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)

22

Image /page/22/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.

System: 1300

Transducer: 9052 (20R3)

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) | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |

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)

(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)

23

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 text is the phrase "powered by analogic" in a smaller font, followed by a gray circle with a white sine wave inside.

System: 1300

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	M	PWD		P	P	P	P	P 2)
Intra-operative (Neuro)	P	M	PWD		P	P	P	P	P 2)
Laparoscopic
Pediatric	P	M	PWD		P	P	P	P	P 2)
Small Organ (Specify)
Neonatal Cephalic	P	M	PWD		P	P	P	P	P 2)
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal. (Conventional)
Musculoskeletal. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult)
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
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. Intra-operative: gallbladder

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

24

Image /page/24/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 smaller gray font below it. The logo is clean and modern, with a focus on the company's name and its association with ultrasound technology.

System: 1300

Transducer: 9063 (N11C5s)

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 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
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral vessel

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

25

Image /page/25/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.

System: 1300

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	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)
Trans-vaginal	P	P	P	P	P	P	P	P 2)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
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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Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

26

Image /page/26/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 the word "ultrasound" are the words "powered by analogic" in a smaller font.

System: 1300

Transducer: 9070 (18L5)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	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.)
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
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
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, superficial anatomy
Elastography

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

27

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: 1300 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	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	E	E	E	E	E	E	E	E 3)
Small Organ (Specify 2)	E	E	E	E	E	E	E	E 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conv.)	E	E	E	E	E	E	E	E 3)
Musculoskeletal (Superf.)	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 3)
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E: LTF 10-10-2016

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: breast, thyroids, testes
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)

28

Image /page/28/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 lowercase letters. Below the word "ultrasound" is the text "powered by analogic" in a smaller font, followed by a gray circle with a white cross inside.

System: 1300 Transducer: 9085 (5Cle)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	Tissue
Harmonic
Imaging	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify 1)	Other
Ophthalmic
Fetal	E	E	E	E	E	E	E	E 2)
Abdominal	E	E	E	E	E	E	E	E 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 (Conv.)	E	E	E	E	E	E	E	E 2)
Musculoskeletal (Superf.)
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:

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)

29

Image /page/29/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: 1300 Transducer: 9086 (14L3e)

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

Clinical Application
Specific
(Tracks I & III)	B	M	PWD	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	N	N	N	N	N	N	N	N 3)
Small Organ (Specify 2)	N	N	N	N	N	N	N	N 3)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculoskeletal (Conv.)	N	N	N	N	N	N	N	N 3)
Musculoskeletal (Superf.)	N	N	N	N	N	N	N	N 3)
Intra-luminal
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Peripheral vessel	N	N	N	N	N	N	N	N 3), 4)
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)

Small Organ: breast, thyroid, testes
Elastography
Vector Flow Imaging (VFI)

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

30

Image /page/30/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white line going through it, 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 a smaller font below it.

System: 1300

Transducer: 9087 (5P1e)

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 | N | N | N | N | N | | N | N | | N | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | | N | N | | N | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | |
| Intra-luminal 17) | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Cardiac Adult 2) | N | N | N | N | N | | N | N | | N | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| 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. Adult Cardiac: Not for direct use on the heart
1. Continuous Wave Doppler (CWD/CW)

(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/31/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features 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 gray with the analogic logo.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter: BK Medical ApS Mileparken 34 Herlev 2730 Denmark Tel: (978) 326-4668 Fax: (978) 977-6808 Contact: Karen Provencher Sr. Regulatory Affairs Specialist E-mail: kprovencher@analogic.com

l.

Date Prepared: January 29, 2018

Device Names / Common Names / Classification Names: II.

Trade Name: Ultrasound System 1300 Common Name: Ultrasound Scanner System Classification Name: Ultrasonic pulsed doppler imaging system Product Code: IYN, IYO, ITX Class: || Regulation Number: 21 CFR §892.1550, §892.1560, §892.1570 Classification Panel: Radiology

lll. I dentification of Predicate or Legally Marketed Devices:

BK2300 Ultrasound Scanner System – K161960 (10/17/2016)

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IV. Device Description:

The Ultrasound System 1300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.

The initial release of the 1300 system will include the BK1500 marketing configuration model.

The transducers are all multi-frequency transducers including:

Phased Linear Array
Convex / Curved Array .
Linear Array. ●

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

Surface Contact, ●
Intra-operative, 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 quidance.

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

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Contraindications:

The Ultrasound System 1300 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.

Comparison of Technological Characteristics with the VI. Predicate Device:

| Item | BK2300 Ultrasound
Scanner System
(predicate device) | Ultrasound System
1300
(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 |
| 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, Small Organ
(also known as Small
Parts), Adult Cephalic
(cephalic is also known
as trans-cranial), | Fetal (including
Obstetrics), Abdominal,
Pediatric, Small Organ
(also known as Small
Parts), Adult Cephalic
(cephalic is also known as
Adult trans-cranial), |
| Item | BK2300 Ultrasound
Scanner System | Ultrasound System
1300 |
| | (predicate device) | (proposed device) |
| | Neonatal Cephalic
(cephalic is also known
as trans-cranial), Intra-
operative, Intra-
operative Neuro (also
known as Neurosurgery),
Trans-rectal, Trans-
vaginal, Trans-
esophageal (cardiac)
Musculo-skeletal
(Conventional and
Superficial), Cardiac
Adult, and Peripheral
Vessel (also known as
Peripheral Vascular) | Neonatal Cephalic, Intra-
operative, Intra-operative
Neuro (also known as
Neurosurgery), Trans-
rectal, Trans-vaginal,
Musculo-skeletal
(Conventional and
Superficial), Cardiac
Adult, 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 | Modified acoustic output
tables for:
9002, 9009, 9011, 9015,
9016, 9018, 9019, 9022,
9023, 9024, 9026, 9029,
9032, 9038, 9040, 9048,
9051, 9052, 9062, 9063,
9067, 9070, 9081, 9085
New transducers:
9008, 9086, 9087 |
| Features | ECG (not monitoring) | ECG (not monitoring) |
| Features | Wi-Fi | Wi-Fi |

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

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VII. Performance Data:

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

Non-clinical /Performance - Bench Testing:

Bench testing was performed and the 1300 system fulfilled the requirements of the following FDA consensus standards and requirements set forth in FDA quidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems 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

Testing to the above-mentioned standards was performed on the proposed Ultrasound System 1300. 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 1300 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 System 1300 is not sold as a sterile device. The transducers require reprocessing prior to use. Testing to support

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recommended methods for reprocessing was performed in accordance with TIR-12 and TIR-30.

Electrical Safety & Electromagnetic Compatibility (EMC):

Electrical safety testing is compliant with the following standards:

AAMI/ANSI/ES 60601-1: Medical electrical equipment Part . 1: General requirements for basic safety and essential performance
IEC 60601-1-2: Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

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 System 1300 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 System 1300 is substantially equivalent to the predicate BK2300 Ultrasound Scanner (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.

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 892.1550 Ultrasonic pulsed doppler imaging system.

Indications for Use

Indications for Use (Describe)

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE

Ultrasound System: 1300

System: 1300

Transducer: 9018 (E14C4t)

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 1300

Additional Comments:

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System: 1300

Transducer: 9051 (14L3)

System: 1300

Transducer: 9062 (N13C5)

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

Additional Comments:

Additional Comments:

Additional Comments:

Transducer: 9087 (5P1e)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Names / Common Names / Classification Names: II.

lll. I dentification of Predicate or Legally Marketed Devices:

IV. Device Description:

V. Indications / Intended Use:

Comparison of Technological Characteristics with the VI. Predicate Device:

VII. Performance Data:

Non-clinical /Performance - Bench Testing:

Biocompatibility:

Sterilization:

Electrical Safety & Electromagnetic Compatibility (EMC):

Software Verification and Validation Testing:

Animal Testing:

Clinical Studies:

VIII. Conclusion:

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