Ultrasound Scanner System BK2300

K151910 · Bk Medical Aps · IYN · Oct 5, 2015 · Radiology

Device Facts

• Record ID: K151910
• Device Name: Ultrasound Scanner System BK2300
• Applicant: Bk Medical Aps
• Product Code: IYN · Radiology
• Decision Date: Oct 5, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (incl Obstetrics) Abdominal Intraoperative Neurosurgery Pediatrics Small Parts (organs) Adult Cephalic Neonatal Cephalic Transrectal Transvaginal Transurethral Muskulo-skeletal (conventional and superficial) Cardiac Peripheral Vessel

Device Story

The bk2300 is a diagnostic ultrasound scanner system used in clinical settings (e.g., OR, clinic) by physicians and trained healthcare professionals. It processes acoustic signals from transducers to generate B-mode, M-mode, PWD, CWD, Color Doppler, Tissue/Contrast Harmonic Imaging, Vector Flow Imaging (VFI), and Elastography. The system supports 3D volume reconstruction from 2D images, biopsy needle guidance, and geometric measurements. An optional RF wireless module enables data transmission for printing and archiving. The device provides real-time visual output on a screen, assisting clinicians in diagnostic imaging and fluid flow analysis. By providing high-resolution anatomical and hemodynamic information, the device aids in clinical decision-making and patient management across various medical specialties.

Clinical Evidence

Bench testing only. The device was evaluated for acoustic output, thermal, electromagnetic, and mechanical safety, and biocompatibility in accordance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1). No clinical data was required for this submission.

Technological Characteristics

System utilizes ultrasonic pulsed echo and Doppler imaging. Materials are biocompatible. Connectivity includes optional RF wireless for printing/archiving. Acoustic output complies with Track 3 limits (MI ≤ 1.9, Ispta ≤ 720 mW/cm², TI ≤ 6.0). Software lifecycle follows IEC 62304. Standards: AIUM/NEMA UD-2, UD-3; IEC 60601-1, 60601-1-2, 60601-2-37, 62359; ISO 14971.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intraoperative, neurosurgical, pediatric, small organ, neonatal/adult cephalic, transrectal, transvaginal, transurethral, musculoskeletal, cardiac, and peripheral vessel applications.

Regulatory Classification

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.

Predicate Devices

• B-K Medical Ultrasound Scanner bk2300 (K143298)

Reference Devices

• Ultrasound scanner ProFocus 2202 (K132346)

Submission Summary (Full Text)

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

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

October 5. 2015

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

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

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

Dear Mrs. Hauerberg:

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

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

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

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

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael O'Hara

For

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

Enclosure

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# ALTHAND HUMAN SERVICES

510(k) Number (if known)

K151910

Device Name

### Ultrasound Scanner System bk2300

Indications for Use (Describe)

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.

### Signal Analysis.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

### An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

Clinical Applications:

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

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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

### FOR FDA USE ONLY

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

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

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

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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

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### Diagnostic Ultrasound Indications for Use Form

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

### System: bk2300

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

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

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

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

#### Additional Comments:

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

- 24) Vector Flow Imaging (VFI)
- 25) Elastography.
- 26) Continuous Wave Doppler (CWD/CW)
- 27) 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)

{6}------------------------------------------------

### Diagnostic Ultrasound Indications for Use Form

### System: bk2300

### Transducer: 9002

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

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

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

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

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

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

#### Additional Comments:

| 1. | Mode combinations: | B+M,<br>B+D,<br>B+C,<br>B+D+C.<br>B includes Tissue Harmonic Imaging<br>D:PWD.<br>C: Color Flow mapping Doppler incl.<br>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)

{7}------------------------------------------------

### Diagnostic Ultrasound Indications for Use Form

### System: bk2300

### Transducer: 9011

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

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

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

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

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

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

#### Additional Comments:

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

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

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

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

### Diagnostic Ultrasound Indications for Use Form

### System: bk2300

### Transducer: 9015

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

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

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

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

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

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

#### Additional Comments:

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

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

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

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

### Diagnostic Ultrasound Indications for Use Form

### System: bk2300

### Transducer: 9016

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

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

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

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

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

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

#### Additional Comments:

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

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

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

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

### Diagnostic Ultrasound Indications for Use Form

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

### System: bk2300

### Transducer: 9018

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

| Clinical Application | | Modes | | | | | | | | | |
|---------------------------------|---|-------|-----|------------|-------------------------------|---------|------------------|----------------------|------------------------------|-------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD<br>26) | Tissue<br>Harmonic<br>Imaging | CHI 27) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined 1) | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal 2) | | | | | | | | | | | |
| Abdominal 3) | | | | | | | | | | | |
| Intra-operative (Specify 4) | | | | | | | | | | | |
| Intra-operative (Neuro 5) | | | | | | | | | | | |
| Laparoscopic 6) | | | | | | | | | | | |
| Pediatric 7) | | | | | | | | | | | |
| Small Organ (Specify 8) | | | | | | | | | | | |
| Neonatal Cephalic 9) | | | | | | | | | | | |
| Adult Cephalic 10) | | | | | | | | | | | |
| Trans-rectal 11) | P | P | P | | P | E | P | P | | P | N25) |
| Trans-vaginal 12) | P | P | P | | P | E | P | P | | P | N25) |
| Trans-urethral 13) | | | | | | | | | | | |
| Trans-esoph. (non-Card.) 14) | | | | | | | | | | | |
| Musculo-skel. (Conventional 15) | | | | | | | | | | | |
| Musculo-skel. (Superficial 16) | | | | | | | | | | | |
| Intra-luminal 17) | | | | | | | | | | | |
| Other (Specify 18) | | | | | | | | | | | |
| Cardiac Adult 19) | | | | | | | | | | | |
| Cardiac Pediatric 20) | | | | | | | | | | | |
| Trans-esoph. (Cardiac 21) | | | | | | | | | | | |
| Other (Specify 22) | | | | | | | | | | | |
| Peripheral vessel 23) | | | | | | | | | | | |
| Other (Specify 24) | | | | | | | | | | | |
| Other (Specify 25) | | | | | | | | | | | N |

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

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

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

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

Additional Comments:

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

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

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

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

### Diagnostic Ultrasound Indications for Use Form

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

### System: bk2300

### Transducer: 9019

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

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

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

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

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

### Additional Comments:

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

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

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

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

### Diagnostic Ultrasound Indications for Use Form

### System: bk2300

### Transducer: 9022

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

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

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

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

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

Additional Comments:

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

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

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

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

### Diagnostic Ultrasound Indications for Use Form

### System: bk2300

### Transducer: 9023

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

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

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

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

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

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

#### Additional Comments:

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

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

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

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

### Diagnostic Ultrasound Indications for Use Form

### System: bk2300

### Transducer: 9024

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

| Clinical Application | | | | | | Modes | | | | | |
|---------------------------------|---|---|-----|---------|-------------------------------|---------|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD 26) | Tissue<br>Harmonic<br>Imaging | CHI 27) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal 2) | | | | | | | | | | | |
| Abdominal 3) | | | | | | | | | | | |
| Intra-operative (Specify 4) | E | E | E | E | E | E | E | E | E | E | E 25) |
| Intra-operative (Neuro 5) | | | | | | | | | | | |
| Laparoscopic 6) | | | | | | | | | | | |
| Pediatric 7) | | | | | | | | | | | |
| Small Organ (Specify 8) | | | | | | | | | | | |
| Neonatal Cephalic 9) | | | | | | | | | | | |
| Adult Cephalic 10) | | | | | | | | | | | |
| Trans-rectal 11) | | | | | | | | | | | |
| Trans-vaginal 12) | | | | | | | | | | | |
| Trans-urethral 13) | | | | | | | | | | | |
| Trans-esoph. (non-Card.) 14) | | | | | | | | | | | |
| Musculo-skel. (Conventional 15) | E | E | E | E | E | E | E | E | E | E | E 25) |
| Musculo-skel. (Superficial 16) | | | | | | | | | | | |
| Intra-luminal 17) | | | | | | | | | | | |
| Other (Specify 18) | | | | | | | | | | | |
| Cardiac Adult 19) | | | | | | | | | | | |
| Cardiac Pediatric 20) | | |…