Ultrasound System 1300
Device Facts
| Record ID | K173569 |
|---|---|
| Device Name | Ultrasound System 1300 |
| Applicant | Bk Medical Aps |
| Product Code | IYN · Radiology |
| Decision Date | Feb 23, 2018 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult trans-cranial), 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).
Device Story
The Ultrasound System 1300 is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various multi-frequency transducers (phased linear, convex/curved, linear arrays). The system processes these signals to display images and fluid flow data in modes including B, M, PWD, CWD, Color Flow Mapping, Tissue Harmonic Imaging, Vector Flow Analysis, Elastography, and Contrast Imaging. Used in clinical settings by trained healthcare professionals, the device provides real-time visualization for diagnostic imaging and interventional guidance (puncture/biopsy). The system displays thermal and mechanical indices to assist clinicians in monitoring bio-effect mechanisms. Output is used by physicians to inform clinical decision-making regarding patient anatomy and pathology. The system includes ECG (non-monitoring) and Wi-Fi connectivity.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including compliance with IEC 60601-2-37, IEC 62359, NEMA UD 2, and IEC 62366-1. Biocompatibility, electrical safety (AAMI/ANSI/ES 60601-1), and electromagnetic compatibility (IEC 60601-1-2) were verified. Software verification and validation were performed per FDA guidance for a moderate level of concern.
Technological Characteristics
Mobile, software-controlled diagnostic ultrasound system. Transducers: multi-frequency phased linear, convex/curved, and linear arrays. Modes: B, M, PWD, CWD, Color Flow Mapping, Tissue Harmonic Imaging, Vector Flow Analysis, Elastography, Contrast Imaging. Connectivity: Wi-Fi, ECG (non-monitoring). Biocompatibility per ISO 10993-1. Electrical safety per AAMI/ANSI/ES 60601-1. Software: moderate level of concern, compliant with EN IEC 62304.
Indications for Use
Indicated for diagnostic ultrasound imaging, fluid flow analysis, and puncture/biopsy guidance in fetal, abdominal, pediatric, small organ, adult/neonatal cephalic, intra-operative (including neuro), trans-rectal, trans-vaginal, musculoskeletal, cardiac adult, and peripheral vessel applications. Contraindicated for ophthalmic use or any use causing the acoustic beam to pass through the eye; cardiac adult application is not for direct use on the heart.
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
- BK2300 Ultrasound Scanner System (K161960)
Related Devices
- K152396 — S12 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Sep 3, 2015
- K123185 — DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2, 2012
- K161960 — bk2300 · Bk Medical Aps · Oct 17, 2016
- K083505 — DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 12, 2008
- K063500 — DC-6 DIAGNOSTIC ULTRASOUND SYSTEM · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 6, 2006
Submission Summary (Full Text)
{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)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data 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 burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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<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 | 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.<br>(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)<br>N 3) | |
| Other (Specify) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; 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, breast
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)
{4}------------------------------------------------
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<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 | 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:
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 (OlR)
{5}------------------------------------------------
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<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) | | | | | | | | | | | |
| 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:
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)
(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}------------------------------------------------
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<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 | | | | | | | | | | | | |
| 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:
1) Mode combinations:
B+M, B+D, B+C, B+D+C. (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
- 4) Small Organ: testicles
(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}------------------------------------------------
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<br>Specific<br>(Tracks I & III) | B | M | PWD | 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 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:
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)
{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<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 | | | | | | | | | | | | |
| 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)
- 2) Elastography
- 3) Intra-operative: Liver, Biliary, Pancreas, Spleen, Gallbladder, Kidney, Stomach, Breast
- 4) 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<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 | 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)
- 2) Elastography
- 3) Inter-operative: Liver, Biliary, Pancreas, Kidney
- 4) 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 | | | | | | Modes | | | | | |
|---------------------------------|---|---|-----|-----|-------------------------------|---------------------------------|------------------|----------------------|------------------------------|----------------|----------|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | Contrast<br>Harmonic<br>Imaging | 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 | 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:
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) 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<br>Specific<br>(Tracks I & III) | B | M | PWD | 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 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:
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)
{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<br>(Tracks I & III) | B | M | PWD | 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 | | | | | | | | | |
| 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:
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) Vector Flow Imaging (VFI)
(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}------------------------------------------------
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<br>Specific<br>(Tracks I & III) | B | M | PWD | Tissue<br>Harmonic<br>Imaging | Color<br>Doppler | Amplitude<br>Doppler | CHI 3) | Combined<br>(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:
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) 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<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 | 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…
