← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K163688
# Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 (K163688)
_Medisono, LLC · IYN · Feb 23, 2017 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K163688
## Device Facts
- **Applicant:** Medisono, LLC
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Feb 23, 2017
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## Intended Use
The MEDISONO Ultraonic Diagnostic Imaging System models P1, P3 and P10, are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatic patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both conventional and superficial), Urology (including prostate), Transrecta and Transvagina.
## Device Story
Portable digital ultrasonic diagnostic imaging systems (models P1, P3, P10) for clinical use in hospitals and clinics. Devices use various transducer arrays (linear, convex, micro-convex, transrectal, transvaginal) to emit ultrasound waves into body tissue and process returned echoes. P10 model incorporates advanced imaging technologies: Phased Inversion Harmonic Compound Imaging (eHCl), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging. Systems display images in B, M, PW, Color, and PDI/DPDI modes on integrated monitors. Operated by physicians or qualified healthcare professionals to perform diagnostic evaluations. Output provides visual anatomical and fluid flow data, assisting clinicians in diagnosis and clinical decision-making across multiple specialties including obstetrics, cardiology, and urology. Benefits include non-invasive, real-time diagnostic imaging.
## Clinical Evidence
No clinical data provided; bench testing only. Safety and performance verified via IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1, ISO 10993-10, and ISO 14971 standards, alongside acoustic output testing per FDA guidance.
## Technological Characteristics
Portable ultrasound systems with 2.0-11 MHz frequency range. Features include B, M, PW, Color, and PDI/DPDI modes. P10 includes eHCl, mBeam, eSRI, and Spatial Compounding. Materials evaluated per ISO 10993. Standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 14971.
## Regulatory 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
- D3, D6 ultrasound system ([K122574](/device/K122574.md))
- DUS 60 ultrasound system ([K110999](/device/K110999.md))
- U50 ultrasound system ([K123249](/device/K123249.md))
## Submission Summary (Full Text)
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{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
MEDISONO, LLC % Jorge Millan, Ph.D. Regulatory Affairs Director HIATEC 601 West 20 Street HIALEAH FL 33010
Re: K163688
Trade/Device Name: MEDISONO Ultrasonic Diagnostic Imaging System, models P1, P3 and P10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 11, 2017 Received: January 12, 2017
Dear Dr. Millan:
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}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
#### Indications for Use
510(k) Number (if known) K163688
#### Device Name
MEDISONO Ultrasonic Diagnostic Imaging System, models P1, P3 and P10
#### Indications for Use (Describe)
The MEDISONO Ultraonic Diagnostic Imaging System models P1, P3 and P10, are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatic patients in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms. The system is intended for use by or on the order of a physician or similarly qualified health care professional for ultrasound evaluation of Fetus, Abdomen, Pediatrics, Small Organ, Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both conventional and superficial), Urology (including prostate), Transrecta and Transvagina.
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 *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P1 Ultrasonic Diagnostic Imaging System
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | Note 1, Note 2 |
| Abdominal | N | N | | | | N | Note 1, Note 2 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | | | Note 1, Note 2 |
| Small Organ (Specify) * | N | N | | | | | Note 1, Note 2 |
| Neonatal Cephalic | N | N | | | | | Note 1, Note 2 |
| Adult Cephalic | | | | | | | |
| Trans-rectal | N | N | | | | N | Note 1, Note 2 |
| Trans-vaginal | N | N | | | | N | Note 1, Note 2 |
| Trans-urethral | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | | | | N | Note 1, Note 2 |
| Musculo-skeletal (Superficial) | N | N | | | | N | Note 1, Note 2 |
| Intravascular | | | | | | | |
| Other (Gynecology) | N | N | | | | N | |
| Cardiac | N | N | | | | N | Note 1, Note 2 |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | Note 1, Note 2 |
| Other (Urology) | N | N | | | | N | Note 1, Note 2 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
Note 2: Needle guide bracket kit
{4}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P1 with C361-1/C341 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| Specific | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | Note 1, Note 2 |
| Abdominal | N | N | | | | N | Note 1, Note 2 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | | N | Note 1, Note 2 |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | N | N | | | | N | Note 1, Note 2 |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | | | | N | Note 1, Note 2 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
Note 2: Needle guide bracket kit
{5}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form P1 with C321-1 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| Specific | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | Note 1, Note 2 |
| Abdominal | N | N | | | | N | Note 1, Note 2 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | | N | Note 1, Note 2 |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | N | N | | | | N | Note 1, Note 2 |
| Cardiac | N | N | | | | N | Note 1, Note 2 |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | | | | N | Note 1, Note 2 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
Note 2: Needle guide bracket kit
{6}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P1 with L741 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | N | N | | | | N | Note 1, Note 2 |
| Neonatal Cephalic | N | N | | | | N | Note 1, Note 2 |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal (Conventional) | N | N | | | | N | Note 1, Note 2 |
| Musculo-skeletal (Superficial) | N | N | | | | N | Note 1, Note 2 |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | Note 1, Note 2 |
| Other (Urology) | N | N | | | | N | Note 1, Note 2 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
Note 2: Needle guide bracket kit
{7}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form P1 with E741 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | N | N | | | | N | Note 1, Note 2 |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | | | | N | Note 1, Note 2 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
Note 2: Needle guide bracket kit
{8}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P1 with E611-1 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | Note 1, Note 2 |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | N | N | | | | N | Note 1, Note 2 |
| Trans-urethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | N | N | | | | N | Note 1, Note 2 |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | | | | N | Note 1, Note 2 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
Note 2: Needle guide bracket kit
{9}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P1 with E611-1 Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | | | | N | Note 1, Note 2 |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | N | N | | | | N | Note 1, Note 2 |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | N | N | | | | N | Note 1, Note 2 |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | | | | N | Note 1, Note 2 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
Note 2: Needle guide bracket kit
{10}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form P3 Ultrasonic Diagnostic Imaging System
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| Specific | B | M | PW | CW | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | N | | | N | Note 1 |
| Abdominal | N | N | N | | | N | Note 1 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | | N | Note 1 |
| Small Organ (Specify) * | N | N | N | | | N | Note 1 |
| Neonatal Cephalic | N | N | N | | | N | Note 1 |
| Adult Cephalic | | | | | | | |
| Trans-rectal | N | N | N | | | N | Note 1 |
| Trans-vaginal | N | N | N | | | N | Note 1 |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1 |
| Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | N | | | N | Note 1 |
| Other (Urology) | N | N | N | | | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{11}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with C363UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| Specific | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | N | | | N | Note 1 |
| Abdominal | N | N | N | | | N | Note 1 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | | N | Note 1 |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | N | | | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{12}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with C362UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| Specific | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | N | | | N | Note 1 |
| Abdominal | N | N | N | | | N | Note 1 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | | N | Note 1 |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | N | | | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{13}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with C343UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|--------------------------|--------------------------|
| | B | M | PW | CW | Color | Combined[1]
(Specify) | Other[2][3]
(Specify) |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | N | | | N | Note 1 |
| Abdominal | N | N | N | | | N | Note 1 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | | N | Note 1 |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | N | | | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{14}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with C321UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | | N | Note 1 |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | N | N | N | | | N | Note 1 |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal (Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | N | | | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{15}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with L743UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | N | N | N | | | N | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1 |
| Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | N | | | N | Note 1 |
| Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{16}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with L742UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | N | N | N | | | N | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1 |
| Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | N | | | N | Note 1 |
| Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{17}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with L742UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | N | N | N | | | N | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1 |
| Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | Note 1 |
| Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{18}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with L763UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | N | N | N | | | N | Note 1 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | N | N | N | | | N | Note 1 |
| Musculo-skeletal (Superficial) | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | N | N | | | | N | Note 1 |
| Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{19}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with L743UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | N | N | N | | | N | Note 1 |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | N | N | N | | | N | Note 1 |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{20}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P3 with L613UA Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|------------------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| Specific | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | N | | | N | Note 1 |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal ( Conventional ) | | | | | | | |
| Musculo-skeletal ( Superficial ) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Gynecology) | | | | | | | |
| Cardiac | N | N | N | | | N | Note 1 |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Additional comments: Combined mode: B+M
Note 1: This feature does not use contrast agent
{21}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form P10 Ultrasonic Diagnostic Imaging System
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|--|
| Specific | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] | |
| Ophthalmic | | | | | | | | |
| Fetal / Obstetrics | N | N | N | | N | N | Note 1, Note 2 | |
| Abdominal | N | N | N | | N | N | Note 1, Note 2 | |
| Intra-operative (Specify) | | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | | |
| Laparoscopic | | | | | | | | |
| Pediatric | N | N | N | | N | N | Note 1, Note 2 | |
| Small Organ (Specify) * | N | N | N | | N | N | Note 1, Note 2 | |
| Neonatal Cephalic | N | N | | | | | Note 1, Note 2 | |
| Adult Cephalic | | | | | | | | |
| Trans-rectal | | | | | | | Note 1, Note 2 | |
| Trans-vaginal | N | N | N | | N | N | Note 1, Note 2 | |
| Trans-urethral | | | | | | | | |
| Musculo-skeletal(Conventional) | N | N | N | | N | N | Note 1, Note 2 | |
| Musculo-skeletal (Superficial) | N | N | N | | N | N | Note 1, Note 2 | |
| Intravascular | | | | | | | | |
| Other (Specify**) | N | N | N | | N | N | Note 1, Note 2 | |
| Adult Cardiac | N | N | N | | N | N | Note 1, Note 2 | |
| Pediatric Cardiac | N | N | | | N | N | Note 1, Note 2 | |
| Intravascular | | | | | | | | |
| Peripheral vascular | N | N | | | N | N | Note 1, Note 2 | |
| Other (Urology) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix. PDI=Power Doppler Imaging.
Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI+PW
*Small organ includes Thyroid, Testes, Breast
**Other use includes Urology, Kidney, Gynecology
Note 1: Biopsy guide
Note 2: Harmonic imaging. This feature does not use contrast agent
{22}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form P10 with C352UB Transducer
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | |
|---------------------------------|-------------------|---|----|----|-------|------------------------|------------------------|
| | B | M | PW | CW | Color | Combined (Specify) [1] | Other (Specify) [2][3] |
| Specific | | | | | | | |
| Ophthalmic | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | Note 1, Note 2 |
| Abdominal | N | N | N | N | N | N | Note 1, Note 2 |
| Intra-operative (Specify) | | | | | | | |
| Intra-operative (Neuro logical) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | | | | | | | |
| Small Organ (Specify) * | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Musculo-skeletal(Conventional) | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | |
| Intravascular | | | | | | | |
| Other (Specify**) | N | N | N | N | N | N | Note 1, Note 2 |
| Adult Cardiac | | | | | | | |
| Pediatric Cardiac | | | | | | | |
| Intravascular | | | | | | | |
| Peripheral vascular | | | | | | | |
| Other (Urology) | | | | | | | |
N= new indication; P = previously cleared by FDA; E = added under this appendix. PDI=Power Doppler Imaging.
Additional comments: Combined mode: B+M, B+PW, B+Color, B+PDI/DPDI, B+Color+PW, B+PDI/DPDI+PW
*Small organ includes Thyroid, Testes, Breast
**Other use includes Urology, Kidney, Gynecology
Not…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K163688](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K163688)
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