(57 days)
Not Found
No
The document describes standard ultrasound imaging technologies and image processing techniques, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an "ultrasonic diagnostic imaging system" intended for "diagnostic ultrasound imaging analysis" and designed to "produce ultrasound waves into body tissue and to present the returned echo information on the monitor," indicating its purpose is for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are intended for diagnostic ultrasound imaging analysis." The "Device Description" also refers to them as "ultrasonic diagnostic system" and mentions "ultrasound diagnostic examination."
No
The device description explicitly states that the system consists of a "main unit, transducers and other accessories" or "main unit, a display and transducers," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description clearly states that this system produces ultrasound waves into body tissue and presents the returned echo information on a monitor. This is direct imaging of the body, not analysis of a biological sample taken from the body.
- The intended use and device description focus on imaging internal structures. The listed anatomical sites and applications (Fetus, Abdomen, Cardiology, etc.) are all areas within the body that are visualized using ultrasound.
- There is no mention of analyzing biological samples. The process described is about generating and interpreting ultrasound images, not performing tests on blood, urine, tissue, or other bodily fluids or materials.
Therefore, the MEDISONO Ultrasonic Diagnostic Imaging System models P1, P3, and P10 are diagnostic imaging devices, not IVD devices.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The P1 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B3-Mode, M-Mode, B+M Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHZ- 10.0MHz. The system consists of a main unit, transducers and other accessories.
The P3 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: B-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz. The system consists of a main unit, a display and transducers.
The P10 model is a portable Diagnostic Ultrasound System, which applies device advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCl), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Bmode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetus, Abdomen, Pediatrics, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Cardiology, Peripheral Vessel, Musculo-skeleton (both conventional and superficial), Urology (including prostate), Transrecta, Transvagina, Kidney, Gynecology.
Indicated Patient Age Range
Adults, pregnant women, pediatric patients.
Intended User / Care Setting
Physician or similarly qualified health care professional, in gynecology rooms, obstetrics rooms, examination rooms, intensive care units, and emergency rooms.
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)
Clinical Test: Clinical testing is not required.
Non-clinical Test: The following safety standards are conducted on the subject device:
- (1) IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety and Essential Performance. 2012 A(2)
- (2) IEC 60601-2-37 Medical Electrical Equipment- Part 2-37. Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment: Nov, 2005
- (3) IEC 60601-1-2 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility Requirements and Tests: March 2007
- (4) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
- (5) ISO 10993-1 Biological Evaluation of Medical Devices Tests for In Vitro Cytotoxicity: May, 1999
- (6) ISO 10993-10 Biological Evaluation of Medical Devices Part 10 -Tests for Irritation and Skin Sensitization: Aug, 2010
- (7) ISO 14971 Medical Devices Application of Risk Management to Medical Devices: March 1, 2007
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
Note 1: Biopsy guide
Note 2: Harmonic imaging. This feature does not use contrast agent
23
Diagnostic Ultrasound Indications for Use Form P10 with L1042UB 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 | N | Note 1, Note 2 | |
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| 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**) | |||||||
| Adult Cardiac | |||||||
| Pediatric Cardiac | |||||||
| Intravascular | |||||||
| Peripheral vascular | N | 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
24
Diagnostic Ultrasound Indications for Use Form P10 with L742UB 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 | N | Note 1, Note 2 | |
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | Note 1, Note 2 | |
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | N | N | N | N | N | Note 1, Note 2 | |
| Other (Specify**) | |||||||
| Adult Cardiac | |||||||
| Pediatric Cardiac | |||||||
| Intravascular | |||||||
| Peripheral vascular | N | 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
25
Diagnostic Ultrasound Indications for Use Form P10 with E612UB 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 | |||||||
| Trans-vaginal | N | N | N | N | N | Note 1, Note 2 | |
| Trans-urethral | |||||||
| Musculo-skeletal(Conventional) | |||||||
| Musculo-skeletal (Superficial) | |||||||
| Intravascular | |||||||
| Other (Specify**) | |||||||
| 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
Note 1: Biopsy guide
Note 2: Harmonic imaging. This feature does not use contrast agent
26
Diagnostic Ultrasound Indications for Use Form P10 with C612UB 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 | 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 (Specify**) | |||||||
| Adult Cardiac | |||||||
| Pediatric Cardiac | N | N | N | N | N | Note 1, Note 2 | |
| 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
Note 1: Biopsy guide
Note 2: Harmonic imaging. This feature does not use contrast agent
27
Diagnostic Ultrasound Indications for Use Form P10 with C6152UB 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 | 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 (Specify**) | |||||||
| Adult Cardiac | |||||||
| Pediatric Cardiac | N | N | N | N | N | Note 1, Note 2 | |
| 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
Note 1: Biopsy guide
Note 2: Harmonic imaging. This feature does not use contrast agent
28
Diagnostic Ultrasound Indications for Use Form P10 with C422UB 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 | 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**) | |||||||
| Adult Cardiac | N | N | N | N | N | Note 1, Note 2 | |
| 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
Note 1: Biopsy guide
Note 2: Harmonic imaging. This feature does not use contrast agent
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Diagnostic Ultrasound Indications for Use Form P10 with L552UB 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 | N | N | Note 1, Note 2 |
| Small Organ (Specify) * | N | N | N | N | N | N | Note 1, Note 2 |
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vaginal | |||||||
| Trans-urethral | |||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1, Note 2 |
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | Note 1, Note 2 |
| Intravascular | |||||||
| Other (Specify**) | |||||||
| Adult Cardiac | |||||||
| Pediatric Cardiac | |||||||
| Intravascular | |||||||
| Peripheral vascular | N | N | 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
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510K SUMMARY
MEDISONO Ultrasonic Diagnostic Imaging System
- SUBMITTER MEDISONO, LLC 3511 SILVERSIDE RD STE 105 WILMINGTON, de 19810 Phone: 7864165587 Fax: 7864165587
US AGENT JORGE MILLAN, PHD Official Correspondent for MEDISONO, LLC 601 WEST 20 St., HIALEAH, FL 33010 Email: jorgemillan4407@gmail.com Web: https://www.sigmabiomedical.com
DEVICE NAME AND CLASSIFICATION
| TRADE NAME: | MEDISONO Ultrasonic Diagnostic Imaging System, models P1
P3 and P10 |
| ------------- | ------------------------------------------------------------------------ |
|---|
CLASSIFICATION NAME: 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Product Code: IYN 892.1560 Ultrasonic, Pulsed Echo, Imaging Product Code: IYO 892.1570 Transducer, Ultrasonic, Diagnostic Product Code: ITX
| REGULATORY CLASS: | Class II |
|---|---|
| PANEL IDENTIFICATION | Radiology |
DEVICE DESCRIPTION
The P1 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor, the resulting information is displayed in five display modes: B-Mode, 2B3-Mode, M-Mode, B+M Mode, B+M Mode. This system controlled by software is a Track 1 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0M11z- 10.0MHz. The system consists of a main unit, transducers and other accessories.
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The P3 model is a portable digital ultrasonic diagnostic system applied in ultrasound diagnostic examination of abdominal, obstetrical, small parts, gynecological, orthopedic, cardiac, and urological applications. It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor; the resulting information is displayed in the following display modes: B-Mode, B+M Mode and PW Mode. This system controlled by software is a Track 3 device that employs an array of probes that include linear array, convex linear array, microconvex linear array, transrectal and transvaginal with a frequency range of approximately 2.0MHz-10.0MHz. The system consists of a main unit, a display and transducers.
The P10 model is a portable Diagnostic Ultrasound System, which applies device advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCl), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in Bmode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.
Predicate Devices: The proposed system models are substantially equivalent to diagnostic ultrasound systems cleared for marketing in the US. The MEDISONO model P1 is equivalent to the D3, D6 ultrasound system (K122574); the P2 model is equivalent to the DUS 60 ultrasound system (K110999), and the P10 model is equivalent to the U50 ultrasound system (K123249). All diagnostic ultrasound systems and transducers are manufactured by EDAN Instruments Inc.
Indications for Use: The MEDISONO Ultrasonic Diagnostic Imaging System models P1, P3 and P10 are intended for diagnostic ultrasound imaging analysis of adults, pregnant women, pediatric 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.
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EFFECTIVENESS AND SAFETY CONSIDERATIONS
Clinical Test:
Clinical testing is not required.
Non-clinical Test:
The following safety standards are conducted on the subject device:
- (1) IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety and Essential Performance. 2012 A(2)
- (2) IEC 60601-2-37 Medical Electrical Equipment- Part 2-37. Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment: Nov, 2005
- (3) IEC 60601-1-2 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility Requirements and Tests: March 2007
- (4) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008.
- (5) ISO 10993-1 Biological Evaluation of Medical Devices Tests for In Vitro Cytotoxicity: May, 1999
- (6) ISO 10993-10 Biological Evaluation of Medical Devices Part 10 -Tests for Irritation and Skin Sensitization: Aug, 2010
- (7) ISO 14971 Medical Devices Application of Risk Management to Medical Devices: March 1, 2007
COMPARISON TO PREDICATE DEVICE
The subject device has similar technology characteristics and has the same intended use, same design principle, same electrical classification, same manufacturing processes, materials and same accuracy. There are no differences between the devices that affect the usage, safety and effectiveness, thus no new question is raised regarding the safety and effectiveness.
Substantially Equivalent Determination
The evaluation of the MEDISONO ultrasonic diagnostic imaging system does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.