Ultrasound Scanner System bk2300
Device Facts
| Record ID | K180737 |
|---|---|
| Device Name | Ultrasound Scanner System bk2300 |
| Applicant | Bk Medical Aps |
| Product Code | IYN · Radiology |
| Decision Date | Aug 1, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).
Device Story
The bk2300 is a multi-purpose, mobile, software-controlled diagnostic ultrasound scanner system. It acquires primary or secondary harmonic ultrasound echo data via various multi-frequency transducers (linear, phased linear, convex/curved arrays). The system processes these inputs to display images in modes including B, M, PWD, CFM, Tissue Harmonic Imaging, Vector Flow Analysis, CWD, Elastography, and Contrast Imaging. It is operated by qualified healthcare professionals in clinical settings. The system includes a Class 2 laser pointer for needle guidance. Output is displayed on-screen for clinicians to perform imaging, fluid flow analysis, and puncture/biopsy guidance. The device aids in clinical decision-making by providing real-time diagnostic visualization and guidance, potentially improving procedural accuracy and diagnostic confidence.
Clinical Evidence
No clinical data was required to support substantial equivalence. Evidence consists of bench testing, including acoustic output measurements (NEMA UD 2), field characterization (IEC 62359), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and laser safety (IEC 60825-1).
Technological Characteristics
Mobile, software-controlled ultrasound scanner. Transducers: linear, phased linear, convex/curved arrays. Modes: B, M, PWD, CFM, Tissue Harmonic Imaging, Vector Flow Analysis, CWD, Elastography, Contrast Imaging. Connectivity: Wi-Fi. Laser: Class 2 laser pointer. Safety standards: IEC 60601-2-37, IEC 62359, NEMA UD 2, IEC 60825-1.
Indications for Use
Indicated for diagnostic ultrasound imaging, fluid flow analysis, and puncture/biopsy guidance in fetal, abdominal, pediatric, intra-operative (including neuro), laparoscopic, small organ, cephalic (adult/neonatal), trans-rectal, trans-vaginal, musculoskeletal, cardiac (adult/trans-esophageal), and peripheral vascular applications. Contraindicated for ophthalmic use or acoustic beam passage through the eye; cardiac adult application not for direct heart use.
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
- Ultrasound Scanner System bk2300 (K161960)
Related Devices
- K161960 — bk2300 · Bk Medical Aps · Oct 17, 2016
- K151910 — Ultrasound Scanner System BK2300 · Bk Medical Aps · Oct 5, 2015
- K143298 — Ultrasound Scanner System bk2300 · Bk Medical Aps · Jan 16, 2015
- K222441 — Ultrasound System 2300 · Bk Medical Aps · Dec 7, 2022
- K152052 — Ultrasound Scanner System bk2300 · Bk Medical Aps · Sep 16, 2015
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
August 1st, 2018
BK Medical ApS % Ms. Susana Mogensen Regulatory Affairs Manager Mileparken 34 Herlev 2730 DENMARK
Re: K180737
Trade/Device Name: Ultrasound Scanner System bk2300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 20, 2018 Received: June 25, 2018
Dear Ms. Mogensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Bafges
for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K180737
#### Device Name
Ultrasound Scanner System bk2300
### Indications for Use (Describe)
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.
The clinical applications and exam types including Obstetrics), Abdominal. Pediatric. Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).
Contraindications:
The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
The Cardiac Adult application is not intended for direct use on the heart.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
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Image /page/3/Picture/0 description: The image shows the logo for BK Ultrasound. The logo features a green circle with a white sine wave inside, followed by the green text "bk ultrasound". Below the text is the phrase "powered by analogic" in a smaller, gray font, accompanied by a gray circle with a white sine wave inside.
## System: BK2300
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks I & III) | B | M | PWD | CWD 4) | Tissue<br>Harmonic<br>Imaging | CHI 5) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
|------------------------------------------------------|---|---|-----|--------|-------------------------------|--------|------------------|----------------------|------------------------------|----------------|----------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | P | | P | P 3) |
| Abdominal | P | P | P | P | P | P | P | P | | P | P 3) |
| Intra-operative (Specify) 6) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-operative (Neuro) | P | P | P | | P | P | P | P | | P | P 3) |
| Laparoscopic | P | P | P | | P | P | P | P | | P | P 3) |
| Pediatric | P | P | P | | P | P | P | P | | P | P 3) |
| Small Organ (Specify) 7) | P | P | P | | P | P | P | P | | P | P 3) |
| Neonatal Cephalic | P | P | P | | P | P | P | P | | P | P 3) |
| Adult Cephalic | P | P | P | P | P | P | P | P | | P | P 3) |
| Trans-rectal | P | P | P | | P | P | P | P | | P | P 3) |
| Trans-vaginal | P | P | P | | P | P | P | P | | P | P 3) |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | | P | P | P | P | | P | P 3) |
| Musculo-skel. (Superficial) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | P | | P | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | | P | P | P | P | | P | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 2), 3) |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
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)
2) Vector Flow Imaging (VFI)
- 3) Elastography
4) Continuous Wave Doppler (CWD/CW)
5) Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI)
6) Intra-operative: carotids, central blood vessels, aorta, vena cava, liver, biliary, pancreas, spleen, gallbladder, kidney, stomach
7) Small organ: testicles, thyroid, breast, penis, parathyroid, salivary glands, lymph nodes, superficial anatomy
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/4/Picture/0 description: The image is a logo for BK Ultrasound. The logo consists of a green circle with a white wave inside, followed by the green text "bk ultrasound". Below the text is the phrase "powered by analogic" in a smaller font, followed by a gray circle with a white wave inside.
## System: BK2300
# Transducer: 9002 (9C2)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | |
|------------------------------|-------|---|-----|-----|-------------------------------|-----|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
| Ophthalmic | | | | | | | P | P | P | | P 2) |
| Fetal | P | P | P | | P | | P | P | | P | P 2) |
| Abdominal | P | P | P | | P | | P | P | | P | P 2) |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | | P | P 2) |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | | P | | P | P | | P | P 2) |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | | P | P | | P | P 2) |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
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)
2) Elastography
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/5/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in gray with a gray analogic logo.
#### System: BK2300
## Transducer: 9009 (X18L5s)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | |
|---------------------------------|-------|---|-----|-----|-------------------------------|-----|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) 3) | P | P | P | | | | P | P | | P | P 2) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) 4) | P | P | P | | | | P | P | | P | P 2) |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | P | P | P | | | | P | P | | P | P 2) |
| Musculoskeletal. (Superficial) | P | P | P | | | | P | P | | P | P 2) |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult) | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | | | P | P | | P | P 2) |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
- 1) Mode combinations:
- B+M, B+D, B+C, B+D+C. (B, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- 2) Elastography
- 3) Intra-operative: carotids, central blood vessels, aorta, vena cava
- Small Organ: testicles 4)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/6/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, with the words "powered by analogic" in smaller gray font below it, along with a gray circle containing a white wave-like design.
## System: BK2300
## Transducer: 9011 (13L4w)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks I & III) | Modes | | | | | | | | | | |
|------------------------------------------------------|-------|---|-----|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|-------|--|
| | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify 1) | Other | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | P | P 3) | |
| Small Organ (Specify) 2) | P | P | P | P | P | P | P | | P | P 3) | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | P | P | P | P | | P | P 3) | |
| Musculo-skel. (Superficial) | P | P | P | P | P | P | P | | P | P 3) | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | P | P 3) | |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
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)
2) Small Organ: thyroid, breast, testes, penis, parathyroid, salivary glands, lymph nodes.
3) Elastography
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/7/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like design inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in gray with the analogic logo.
#### System: BK2300
## Transducer: 9015 (114C5I)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | |
|------------------------------|-------|---|-----|-----|-------------------------------|--------|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 4) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) 3) | P | P | P | | P | P | P | P | | P | P 2) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | P | P 2) |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
- 1) Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- 2) Elastography
- 3) Intra-operative: Liver, Biliary, Pancreas, Spleen, Gallbladder, Kidney, Stomach, Breast
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)
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Image /page/8/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the letters "bk" in green. To the right of "bk" is the word "ultrasound" in green, and below that is the phrase "powered by analogic" in a smaller font.
## System: BK2300
## Transducer: 9016 (114C5T)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | |
|------------------------------|-------|---|-----|-----|-------------------------------|--------|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 4) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | P | | P | P 2) |
| Intra-operative Specify) 3) | P | P | P | | P | P | P | P | | P | P 2) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
- Mode combinations: 1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- 2) Elastography
- 3) Inter-operative: Liver, Biliary, Pancreas, Kidney
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in a smaller font, accompanied by a gray circle with a white sine wave inside.
#### System: BK2300
#### Transducer: 9018 (E14C4t)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks I & III) | Modes | | | | | | | | | | | |
|------------------------------------------------------|-------|---|-----|-----|-------------------------------|------------------------------------|------------------|----------------------|------------------------------|----------------|-------|--|
| | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | Contrast<br>Harmonic<br>Imaging 3) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>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 | P 2) | |
| Trans-vaginal | P | P | P | | P | P | P | P | | P | P 2) | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Cardiac Adult) | | | | | | | | | | | | |
| Cardiac Pediatric) | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Peripheral vessel) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- 2) Elastography
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 3)
(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 text "bk ultrasound" in green sans-serif font. Below the word "ultrasound" is the text "powered by analogic" in a smaller, gray sans-serif font, accompanied by a gray circle with a white sine wave inside.
## System: BK2300
## Transducer: 9019 (E10C4)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | |
|---------------------------------|-------|---|-----|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify 1) | Other |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P | P | P 2) |
| Abdominal | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Trans-rectal | P | P | P | P | P | P | P | P | P | P 2) |
| Trans-vaginal | P | P | P | P | P | P | P | P | P | P 2) |
| Trans-urethral | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
2) Elastography
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image is a logo for BK Ultrasound. The logo features a green sphere with a white sine wave inside of it, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in gray, followed by a gray circle with a white "A" inside of it.
#### System: BK2300
## Transducer: 9022 (10L2w)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Specific<br>(Tracks I & III) | Modes | | | | | | | | | | |
|------------------------------------------------------|-------|---|-----|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|---------|--|
| | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify 1) | Other | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | | P | P 2),3) | |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
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)
2) Elastography
Vector Flow Imaging (VFI) 3)
(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 text is the phrase "powered by analogic" in a smaller, gray font, accompanied by a gray circle containing a stylized "A".
#### System: BK2300
## Transducer: 9023 (6C2s)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | |
|---------------------------------|-------|---|-----|-----|-------------------------------|--------|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 3) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>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.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | | | | | | | | | | | |
| Musculoskeletal. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
- Mode combinations: 1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- 2) Elastography
- 3) 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)
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white sine wave inside, followed by the text "bk ultrasound" in green. Below the text is the phrase "powered by analogic" in gray, accompanied by a gray circle with a white "A" inside.
#### System: BK2300
## Transducer: 9024 (112C5b)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | |
|---------------------------------|-------|---|-----|-----|-------------------------------|--------|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 4) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative Specify 2) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculoskeletal. (Conventional) | P | P | P | | P | P | P | P | | P | P 3) |
| Musculoskeletal. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 3) |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K161960; E= added under Appendix E
Additional Comments:
- Mode combinations: 1)
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- 2) Intra-operative: Liver, Biliary, Pancreas, Kidney
- 3) Elastography
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI) 4)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for BK Ultrasound. The logo consists of a green circle with a white wave-like line running through it, followed by the text "bk ultrasound" in green. Below the text, in a smaller font, is the phrase "powered by analogic" with the analogic logo.
#### System: BK2300
## Transducer: 9026 (X12C4)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | |
|------------------------------|-------|---|-----|-----|-------------------------------|--------|------------------|----------------------|------------------------------|----------------|-------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 4) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative Specify 2) | P | P | P | | P | P | P | P | | P | P 3) |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | |…
