bk2300
Device Facts
| Record ID | K161960 |
|---|---|
| Device Name | bk2300 |
| Applicant | Bk Medical Aps |
| Product Code | IYN · Radiology |
| Decision Date | Oct 17, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, 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).
Device Story
The bk2300 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 arrays). The system processes these signals to display images in multiple modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Tissue Harmonic Imaging, Contrast Harmonic Imaging). It features Vector Flow Imaging (VFI) for axial/transverse velocity visualization, ECG display for heart activity monitoring, and an optional battery power source. Used in clinical settings by trained healthcare professionals for imaging, flow analysis, and biopsy guidance. Output is displayed on-screen, including thermal/mechanical indices. The device supports RF wireless connectivity for printing and archiving. Clinical benefits include real-time visualization for diagnostic assessment and procedural guidance.
Clinical Evidence
Bench testing only. Performance, verification, and validation testing were conducted to characterize the device. The system complies with EN IEC 62304 (software life-cycle), EN 60601-1 (safety), EN 60601-1-2 (EMC), EN 60601-2-37 (ultrasonic safety), and EN 62359 (thermal/mechanical indices). All predetermined acceptance criteria were met.
Technological Characteristics
Mobile, software-controlled ultrasound system. Multi-frequency transducers (phased linear, convex/curved). Modes: B, M, PWD, CWD, Color/Amplitude Doppler, Tissue/Contrast Harmonic Imaging. Connectivity: RF wireless for printing/archiving. Power: AC or battery. Standards: EN IEC 62304, EN 60601-1, EN 60601-1-2, EN 60601-2-37, EN 62359.
Indications for Use
Indicated for diagnostic ultrasound imaging, fluid flow analysis, and puncture/biopsy guidance in fetal, abdominal, pediatric, small organ, cephalic (adult/neonatal), intraoperative (neuro), transrectal, transurethral, musculoskeletal, cardiac (adult), transesophageal cardiology, and peripheral vessel applications. Contraindicated for ophthalmic use or acoustic beam passage through the eye; cardiac adult application 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
Related Devices
- K151910 — Ultrasound Scanner System BK2300 · Bk Medical Aps · Oct 5, 2015
- K180737 — Ultrasound Scanner System bk2300 · Bk Medical Aps · Aug 1, 2018
- K143298 — Ultrasound Scanner System bk2300 · Bk Medical Aps · Jan 16, 2015
- K152052 — Ultrasound Scanner System bk2300 · Bk Medical Aps · Sep 16, 2015
- K173569 — Ultrasound System 1300 · Bk Medical Aps · Feb 23, 2018
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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
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# 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)
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#### System: bk2300
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 | 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)<br>P 3) | |
| Other (Specify) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; 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): Previously cleared in K143298
3) Elastography: Previously cleared in K143298
4) Continuous Wave Doppler (CWD/CW): Previously cleared in K143298
5) 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)
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#### System: bk2300
#### Transducer: 9027 (T7P2m)
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 2) | Tissue<br>Harmonic<br>Imaging | CHI 3) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Specify) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| 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:
- 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) Continuous Wave Doppler (CWD/CW): Previously cleared in K143298
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)
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System: bk2300
Transducer: 9002 (9C2)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Modes | | | | | | | | | | | |
|------------------------------|-------|---|-----|-----|-------------------------------|-----|------------------|----------------------|------------------------------|----------------|-------|--|
| Specific<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other | |
| Ophthalmic | | | | | | | | | | | | |
| 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:
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: 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<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) | 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:
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 (OIR)
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# 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<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 K140428; 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: 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)
{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<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 K140428; 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: Previously cleared in K143298
- Inter-operative: Liver, Biliary, Pancreas, Kidney, Stomach, Breast 3)
- 4) 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<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 4) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | P | | P | P 2) | |
| Intra-operative (Specify) 3) | P | P | P | | P | P | P | P | | P | P 2) | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | | | | | | | | | | | | |
| Musculo-skel. (Superficial) | | | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| 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:
- 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: Previously cleared in K143298
- 3) Inter-operative: Liver, Biliary, Pancreas, Kidney
- 4) 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<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 3) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined 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:
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: Previously cleared in K143298
- 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)
{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<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.) | | | | | | | | | |
| 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:
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: 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<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 | P2), P 3) |
| Other (Specify) | | | | | | | | | |
N= new indication; P= previously cleared by FDA in K140428; 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: Previously cleared in K143298
- 3) 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 (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<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), 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:
- 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: Previously cleared in K143298
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 (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<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 4) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify 2) | P | P | P | | P | P | P | P | | P | P 3) | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | | | | |
| Neonatal Cephalic) | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Conventional) | 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:
- 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) Intra-operative: Liver, Biliary, Pancreas, Kidney
- 3) Elastography: Previously cleared in K143298
- 4) 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<br>(Tracks I & III) | B | M | PWD | CWD | Tissue<br>Harmonic<br>Imaging | CHI 4) | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>1) | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intra-operative (Specify 2) | P | P | P | | P | P | P | P | | P | P 3) | |
| Intra-operative (Neuro) | | | | | | | | | | | | |
| Laparosco…
