(91 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound technology.
No
The device is described as a "diagnostic ultrasound imaging system" and its purpose is to "acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes," which points to diagnostic rather than therapeutic use.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "The system is a diagnostic ultrasound imaging system..." and the "Device Description" section begins with, "The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic ultrasound system..."
No
The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system" and mentions the inclusion of transducers, which are hardware components essential for ultrasound imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this is a diagnostic ultrasound imaging system. Ultrasound imaging uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging, fluid flow analysis, and guidance for procedures like puncture and biopsy. While these procedures might involve obtaining samples, the device itself is used for visualization and guidance during the procedure, not for analyzing the sample in vitro.
- Device Description: The description focuses on the hardware (scanner, transducers) and software used to acquire and display ultrasound data. There is no mention of reagents, assays, or any components typically associated with in vitro testing.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.
The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans-urethral, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).
Contraindications:
- The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
- The Cardiac Adult application is not intended for direct use on the heart.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.
The transducers are all multi-frequency transducers including:
- Phased Linear Array 0
- o Convex/Curved linear array.
The interaction with the patients is dependent upon the transducer type which may be:
- 0 Surface contact.
- Intra-operative, or
- 0 contact through Endocavity
when used in locations as described by the indications for use.
The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed doppler imaging system (Ultrasound)
Anatomical Site
Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans-urethral, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have confirmed that the proposed device is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K151910, K132346, K140729, K103629
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2016
BK Medical ApS % Ms. Karen Provencher Sr. Regulatory Specialist Mileparken 34 Herlev 2730 DENMARK
Re: K161960 Trade/Device Name: bk2300 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 19, 2016 Received: July 20, 2016
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 (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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'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) K161960
Device Name 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 include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans-urethral, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, 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 eve.
· The Cardiac Adult application is not intended for direct use on the heart.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
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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
System: bk2300
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD 4) | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 5) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Intra-operative (Specify) | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Intra-operative (Neuro) | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Small Organ (Specify) | P | P | P | P | P | P | P | P | P | P | P3) | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Trans-rectal | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Trans-vaginal | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Trans-urethral | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Musculo-skel. (Superficial) | P | P | P | P | P | P | P | P | P | P | P 3) | |
| Intra-luminal | | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | N | N | N | | |
| Peripheral vessel | P | P | P | P | P | P | P | P | P | P | P 2)
P 3) | |
| Other (Specify) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
-
Vector Flow Imaging (VFI): Previously cleared in K143298
-
Elastography: Previously cleared in K143298
-
Continuous Wave Doppler (CWD/CW): Previously cleared in K143298
-
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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
System: bk2300
Transducer: 9027 (T7P2m)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks I & III) | B | M | PWD | CWD 2) | Tissue | ||||||||
| Harmonic | |||||||||||||
| Imaging | CHI 3) | Color | |||||||||||
| Doppler | Amplitude | ||||||||||||
| Doppler | Color | ||||||||||||
| Velocity | |||||||||||||
| Imaging | Combined |
- | Other | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | | | |
| Intra-luminal 17) | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Trans-esoph. Cardiac | N | N | N | N | N | N | N | N | | N | N | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel) | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
Continuous Wave Doppler (CWD/CW): Previously cleared in K143298
-
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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)
5
System: bk2300
Transducer: 9002 (9C2)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| 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 K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Elastography: Previously cleared in K143298
(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)
6
System: bk2300
Transducer: 9009 (X18L5s)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | P | P | P | | P | | P | P | | P | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | P | P | P | | P | | P | P | | P | | |
| Neonatal Cephalic) | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | | P | | P | P | | P | | |
| Musculo-skel. (Superficial) | P | P | P | | P | | P | P | | P | | |
| Intra-luminal | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult) | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | | P | P | | P | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
7
Fill out one form for each ultrasound system and each transducer.
System: bk 2300
Transducer: 9011 (13L4w)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (Tracks I & III) | B | M | PWD | Tissue | |||||
| Harmonic | |||||||||
| Imaging | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify 1) | Other | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P 3) | |
| Small Organ (Specify) 2) | P | P | P | P | P | P | P | P 3) | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | P | P | P | P 3) | |
| Musculo-skel. (Superficial) | P | P | P | P | P | P | P | P 3) | |
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P 3) | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Small Organ: thyroid, breast, testes, penis, parathyroid, salivary glands, lymph nodes.
-
- Elastography: Previously cleared in K143298
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
- Elastography: Previously cleared in K143298
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OlR)
8
System: bk2300 (bk5000)
Transducer: 9015 (114C5I)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 4) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) 3) | P | P | P | | P | P | P | P | | P | P 2) | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | P | P 2) | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
- Elastography: Previously cleared in K143298
-
Inter-operative: Liver, Biliary, Pancreas, Kidney, Stomach, Breast 3)
-
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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
System: bk2300 (bk5000)
Transducer: 9016 (114C5T)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 4) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | P | | P | P 2) | |
| Intra-operative (Specify) 3) | P | P | P | | P | P | P | P | | P | P 2) | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
- Elastography: Previously cleared in K143298
-
- Inter-operative: Liver, Biliary, Pancreas, Kidney
-
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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
Fill out one form for each ultrasound system and each transducer.
System: bk2300 (bk3000, bk5000)
Transducer: 9018 (E14C4t)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | ||||||
| Harmonic | |||||||||||
| Imaging | CHI 3) | Color | |||||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined 1) | Other | |||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative (Specify) | |||||||||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) | |||||||||||
| Neonatal Cephalic) | |||||||||||
| Adult Cephalic) | |||||||||||
| Trans-rectal | P | P | P | P | P | P | P | P | P | P2) | |
| Trans-vaginal | P | P | P | P | P | P | P | P | P | P2) | |
| 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 K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
-
- Elastography: Previously cleared in K143298
-
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Transducer: 9019 (E10C4)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (Tracks I & III) | B | M | PWD | Tissue | |||||
| Harmonic | |||||||||
| Imaging | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify 1) | Other | ||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | P 2) | |
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify ) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | P 2) | |
| Trans-vaginal | P | P | P | P | P | P | P | P 2) | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| 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 K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Elastography: Previously cleared in K143298
(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
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Transducer: 9022 (10L2w)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (Tracks I & III) | B | M | PWD | Tissue | |||||
| Harmonic | |||||||||
| Imaging | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify 1) | Other | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P | P2), P 3) |
| Other (Specify) |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Elastography: Previously cleared in K143298
-
- Vector Flow Imaging (VFI): Previously cleared in K143298
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
- Vector Flow Imaging (VFI): Previously cleared in K143298
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
13
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: bk2300 Transducer: 9023 (6C2s)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (Tracks I & III) | B | M | PWD | Tissue | |||||
| Harmonic | |||||||||
| Imaging | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify 1) | Other | ||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | P 2), P 3) | |
| Abdominal | P | P | P | P | P | P | P | P 2), P 3) | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P 2), P 3) | |
| 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 K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
Elastography: Previously cleared in K143298
-
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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) Prescription Use (Per 21 CFR 801.109)
14
System: bk2300 (bk3500, bk5000)
Transducer: 9024 (112C5b)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 4) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify 2) | P | P | P | | P | P | P | P | | P | P 3) | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | P | P | P | | P | P | P | P | | P | P 3) | |
| 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 3) | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C, (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
- Intra-operative: Liver, Biliary, Pancreas, Kidney
-
- Elastography: Previously cleared in K143298
-
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K 143298
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
15
System: bk2300 (bk5000)
Transducer: 9026 (X12C4)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 4) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify 2) | P | P | P | | P | P | P | P | | P | P 3) | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
- Intra-operative: Pancreas, Kidney, Liver
-
- Elastography: Previously cleared in K143298
-
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298 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)
16
System: bk2300
Transducer: 9032 (8L2)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 4) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | | P | P 3) | |
| Small Organ (Specify 2) | P | P | P | | P | P | P | P | | P | P 3) | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | |
| Peripheral vessel | P | P | P | | P | P | P | P | | P | P 3) | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
- Small Organ: Thyroid, Breast, Testes
-
- Elastography: Previously cleared in K143298
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
17
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Transducer: 9040 (6C2)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (Tracks I & III) | B | M | PWD | Tissue | |||||
| Harmonic | |||||||||
| Imaging | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify 1) | Other | ||||||||
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | P | P 2) | |
| Abdominal | P | P | P | P | P | P | P | P 2) | |
| Intra-operative (Specify ) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify ) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Conventional) | P | P | P | P | P | P | P | P2) | |
| 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 K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M. B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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)
18
Fill out one form for each ultrasound system and each transducer.
System: bk 2300 (bk3000, bk5000)
Transducer: 9048 (E14CL4b)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (Tracks I & III) | B | M | PWD | Tissue | |||||
| Harmonic | |||||||||
| Imaging | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify 1) | Other | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | P | P 2), P 3) | |
| Trans-vaginal | P | P | P | P | P | P | P | P 2), P 3) | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Conventional) | |||||||||
| Musculo-skel. (Superficial) | |||||||||
| Intra-luminal | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| Peripheral vessel) | |||||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
-
Elastography: Previously cleared in K143298
-
Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K 143298
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
19
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Transducer: 9051 (14L3)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | Contrast | |||||||||||
| Harmonic | ||||||||||||
| Imaging | Color | |||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined 1) | Other | ||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P3) | ||||
| Small Organ (Specify 2) | P | P | P | P | P | P | P | P3) | ||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skel. (Conventional) | P | P | P | P | P | P | P | P3) | ||||
| Musculo-skel. (Superficial) | P | P | P | P | P | P | P | P3) | ||||
| Intra-luminal | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Trans-esoph. (Cardiac ) | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P3) | ||||
| P4) | ||||||||||||
| Other (Specify ) |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
-
- Small Organ: Breast, Thyroids, Testes
-
- Elastography: Previously cleared in K 143298
-
- Vector Flow Imaging (VFI): Previously cleared in K143298
(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)
20
System: bk2300 (bk3000, bk5000)
Transducer: 9052 (20R3)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | ||||||||
| Harmonic | |||||||||||||
| Imaging | CHI | Color | |||||||||||
| Doppler | Amplitude | ||||||||||||
| Doppler | Color | ||||||||||||
| Velocity | |||||||||||||
| Imaging | Combined |
- | Other | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | P | | | | | | | | | | | | |
| Trans-vaginal | P | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
21
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Transducer: 9062 (N13C5)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | Contrast | |||||||||||
| Harmonic | ||||||||||||
| Imaging | Color | |||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined 1) | Other | ||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify 2) | P | P | P | P | P | P | P | P | P3) | |||
| Intra-operative (Neuro) | P | P | P | P | P | P | P | P | P3) | |||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P3) | |||
| Small Organ (Specify) | ||||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P3) | |||
| 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 K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
Inter-operative: Gallbladder 2)
-
- Elastography: Previously cleared in K143298
(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)
22
Fill out one form for each ultrasound system and each transducer.
System: bk2300 (bk5000)
Transducer: 9063 (N11C5s)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 3) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined 1) | Other | ||||||||||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify 2) | P | P | P | P | P | P | P | P | ||||
| Intra-operative (Neuro) | P | P | P | P | P | P | P | P | ||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| 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 K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
-
- Intra-operative: Gall Bladder
-
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
(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)
23
System: bk2300 (bk5000)
Transducer: 9066 (112C4f)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific | ||||||||||||
| (Tracks I & III) | B | M | PWD | CWD | Tissue | |||||||
| Harmonic | ||||||||||||
| Imaging | CHI 3) | Color | ||||||||||
| Doppler | Amplitude | |||||||||||
| Doppler | Color | |||||||||||
| Velocity | ||||||||||||
| Imaging | Combined |
- | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify 2) | P | P | P | | P | P | P | P | P | P | P 4) | |
| 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 K140428; E= added under Appendix E
Additional Comments:
-
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Mode combinations:
-
- Intra-operative: Liver, Biliary, Pancreas, Kidney, Stomach
-
- Contrast Harmonic Imaging (CHI)/Contrast Imaging (CI): Previously cleared in K143298
-
- Elastography: Previously cleared in K143298
(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)
24
Fill out one form for each ultrasound system and each transducer.
System: bk2300 (bk3000)
Transducer: 9067 (E14C4)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application Specific
(Tracks I & III) | B | M | PWD | Tissue
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify 1) | Other |
|---------------------------------------------------|---|---|-----|-------------------------------|------------------|----------------------|------------------------------|-------------------------|-------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Trans-rectal | P | P | P | P | P | P | | P | P 2) |
| Trans-vaginal | P | P | P | P | P | P | | P | P 2) |
| Trans-urethral | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | |
| Intra-luminal | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Cardiac Adult | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Peripheral vessel | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Elastography: Previously cleared in K143298
(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)
25
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Transducer: 9070 (18L5)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (Tracks I & III) | B | M | PWD | Tissue | |||||
| Harmonic | |||||||||
| Imaging | Color | ||||||||
| Doppler | Amplitude | ||||||||
| Doppler | Color | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (Specify 1) | Other | ||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | P 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 K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Small Organ: thyroid, breast, testes, superficial anatomy.
-
- Elastography: Previously cleared in K143298
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
- Elastography: Previously cleared in K143298
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
26
Fill out one form for each ultrasound system and each transducer.
System: bk2300
Transducer: 9077 (5P1)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Specific
(Tracks I & III) | B | M | PWD | CWD
2) | Tissue
Harmonic
Imaging | Contrast
Harmonic
Imaging | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined 1) | Other |
|------------------------------------------------------|---|---|-----|-----------|-------------------------------|---------------------------------|------------------|----------------------|------------------------------|-------------|-------|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | | P | P | | P | |
| Intra-operative (Specify) | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | | P | P | | P | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | | P | P | | P | |
| Cardiac Pediatric | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
| Peripheral vessel) | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; E= added under Appendix E
Additional Comments:
- Mode combinations:
B+M, B+D, B+C, B+D+C. (B includes Tissue Harmonic Imaging, D is PWD, C is Color Flow mapping Doppler including Amplitude (power) Doppler)
- Continuous Wave Doppler (CWD/CW): Previously cleared in K143298
(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)
27
Image /page/27/Picture/0 description: The image shows the logo for BK Medical, a company that specializes in ultrasound technology. The logo consists of the text "bk medical" in a sans-serif font, with the "bk" in a darker shade of green than the "medical". Below the company name is the text "Analogic Ultrasound Group" in a smaller font. To the right of the company name is a green and white circular graphic.
510(k) Summary 7.
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR 807.92
- A. Submitter's information
| Name: | BK Medical ApS |
|---|---|
| Address: | Mileparken 34 |
| Herlev 2730 | |
| Denmark | |
| FDA Establishment Owner / | |
| Operator Number: | 9680269 |
| Contact person: | Karen Provencher |
| Phone: | 978-326-4668 |
| Fax: | 978-977-6809 |
| Manufacturer: | BK Medical ApS |
| Mileparken 34 | |
| Herlev 2730 | |
| Denmark | |
| Device Name: |
- B.
Trade/Proprietary Name: bk2300 Common Name: Ultrasound system Classification name: Doppler Imaging System and Ultrasonic Pulsed Echo Regulation Medical Specialty: Radiology Review Panel: Radiology Product Code: IYN, IYO, ITX Regulation Number: 892.1550, 892.1560, and 892.1570 Device Classification: 2 Submission type: Traditional 510(k)
C. Substantial Equivalence:
This submission is a Traditional 510(k) device modification as described in the FDA's Guidance document entitled, "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications". In support of this Traditional 510(k), BK Medical ApS has provided certification of compliance to 21 CFR $820.30 Design Control requirements. Design validation testing was performed to ensure that the Ultrasound Scanner System bk2300 with modifications meets design specifications. The Ultrasound Scanner System bk2300 with modifications has been compared to the legally marketed predicate devices as cleared through K151910 (October 5, 2015), K132346 (January 10, 2014), K140729 (5/23/2014), and K103629 (2/2/2011) respectively and is found to be substantially equivalent.
This proposed device is identical to the identified predicates except for the proposed integration of software and transducer for the following:
28
Image /page/28/Picture/0 description: The image shows the logo for BK Medical. The logo consists of the text "bk medical" in a lowercase, sans-serif font, with the letters in a dark teal color. To the right of the text is a circular graphic, which is green and has a white line drawing of a waveform inside of it.
Analogic Ultrasound Group
- Electrocardiograph (ECG) display of the electrical and muscular activity of the heart. o Impulses from the heart are relayed via electrodes to the system and appear as a waveform on the screen measurement display.
- Trans-esophageal visualization of the heart (and other organs) with an ultrasound . transducer. The transducer is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.
D. Device Description/Indications for Use:
The Ultrasound Scanner System bk2300 is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.
The transducers are all multi-frequency transducers including:
- Phased Linear Array 0
- o Convex/Curved linear array.
The interaction with the patients is dependent upon the transducer type which may be:
- 0 Surface contact.
- . Intra-operative, or
- 0 contact through Endocavity
when used in locations as described by the indications for use.
The function of the ultrasound scanner system and its transducers is to acquire primary or secondary harmonic ultrasound echo data and display it in the scanning modes.
Indications for Use:
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.
The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intraoperative (Neuro), Trans rectal, Trans rectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).
Contraindications:
- The 2300 Ultrasound System is not intended for ophthalmic use or any use causing 0 the acoustic beam to pass through the eye.
- The Cardiac Adult application is not intended for direct use on the heart. .
29
Image /page/29/Picture/0 description: The image contains the logo for BK Medical, an Analogic Ultrasound Group. The logo features the text "bk medical" in a sans-serif font, with the letters in a dark green color. Below the company name, the text "Analogic Ultrasound Group" is written in a smaller, lighter green font. To the upper right of the company name is a circular graphic with a green and white design.
Options:
- 0 Vector Flow Imaging (VFI) module is available: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
- . Alternate power source (battery) solution.
- . RF wireless function with the ability to transmit for printing and archive connectivity purposes.
- . Electrocardiograph display of the electrical and muscular activity of the heart. Impulses from the heart are relayed via electrodes to the system and appear as a waveform on the screen.
E. Technological Characteristics
The proposed device has the same technological characteristics and is similar in design and configuration as compared to the currently marketed predicate devices.
F. Summary of Non-clinical Test/Performance Testing - Bench:
BK Medical ApS believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Performance, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have confirmed that the proposed device is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.
The system complies with the following voluntary standards:
- EN IEC 62304:2006 + AC:2008 Medical Device Software Life-Cycle Processes .
- o EN 60601-1:2006 (Ed.3)+AC:2010, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 (Ed.3) + Cor1:2006 + Cor2:2010)
- . EN 60601-1-2:2007+AC:2010, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007)
- 0 EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)
- . EN 62359:2010 Ultrasonic - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2010)