(49 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the description focuses on standard ultrasound technology and operating system updates.
No
The device is described as a "Diagnostic Ultrasound System" and its intended use is for "ultrasound evaluation," which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that it is a "diagnostic ultrasound system," and the "Device Description" also refers to it as a "portable Diagnostic Ultrasound System."
No
The device description explicitly states it is a "portable Diagnostic Ultrasound System" and mentions hardware components like a "12.1 inch LCD and diverse probes," indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device is a diagnostic ultrasound system. Ultrasound systems use sound waves to create images of internal organs and structures within the body. They are used on the patient, not on specimens taken from the patient.
The description clearly states its intended use is for "ultrasound evaluation in hospitals and clinics" for various anatomical sites on patients. This is the definition of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The U50 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images.
The R2.2 version of the U50 utilizes the Linux operating system, which enables additional printer drivers and the inclusion of an USB DVD drive.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed doppler imaging system
Ultrasonic, Pulsed echo, Imaging
Anatomical Site
Abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications. Specific anatomical sites (e.g., eye, fetal/obstetrics, abdominal, intra-operative, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, trans-urethral, musculoskeletal, intravascular, adult cardiac, pediatric cardiac, trans-esophageal, intra-cardiac, peripheral vascular) are mentioned in the detailed indications for use tables for different transducers.
Indicated Patient Age Range
Adults, pregnant women, pediatric patients
Intended User / Care Setting
By or on the order of a physician or similarly qualified health care professional.
Hospitals and clinics.
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)
Non-clinical test: The U50 Ultrasound Imaging System complies with:
(1) IEC 60601-1:2005/A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
(2) IEC 60601-1-2 Edition 3:2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
(3) IEC 60601-2-37 Edition 2.0 2007, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
(4) NEMA UD 3, Edition 2004 Standard for real-time display of thermal and mechanical acoustic output Indies on diagnostic ultrasound equipment.
(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated September 9, 2008.
(6) NEMA, UD2, Edition 2004 for acoustic output measurement methodology.
The following biocompatibility standards are conducted on the subject device:
(1) ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
The tests were selected to show substantial equivalence between the subject device and the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
B-Mode Measurement Accuracy:
Range of Depth/Distance: Maximum 324 mm, Accuracy of Depth/Distance: ≤±5%
Range of Area: Maximum 1126 cm², Accuracy of Area: ≤±10%
Range of Angle: 0-180°, Accuracy of Angle: ≤±3%
Range of Ratio: Maximum 1.0, Accuracy of Ratio: ≤±10%
Range of Volume: Maximum 999 cm³, Accuracy of Volume: ≤±15%
M-mode Measurement Accuracy:
Range of Depth: Maximum 324mm, Accuracy of Depth: ≤±5%
Range of Time: Maximum 13s, Accuracy of Time: ≤±5%
Range of Heart rate: Maximum 999bpm, Accuracy of Heart rate: ≤±5%
Range of Slope: Maximum 999mm/s, Accuracy of Slope: ≤±10%
PW mode velocity Measurement Accuracy:
Range: 0.5-2.5m/s, Accuracy: ≤±10%
CW mode velocity Measurement Accuracy:
Range: 0.5-2.5m/s, Accuracy: ≤±10%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
U50 Diagnostic ultrasound system/ K142511/ Edan Instruments, Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
November 15, 2017
Image /page/0/Picture/1 description: The image contains two logos. The first logo is the Department of Health & Human Services - USA logo, which features a stylized eagle. The second logo is the U.S. Food & Drug Administration (FDA) logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text to the right of the square.
Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Ave, Suite 200 SUNNYVALE CA 94089
Re: K173003
Trade/Device Name: U50 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 1, 2017 Received: November 6, 2017
Dear Mr. Worth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173003
Device Name
U50 Diagnostic Ultrasound System
Indications for Use (Describe)
The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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."
FORM FDA 3881 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
U50 Diagnostic Ultrasound System
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Combined | |||
| (Specify) [1] | Other | ||||||||
| (Specify) [2][3] | |||||||||
| General | Specific | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | |||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | |||
| Small Organ (Specify) * | P | P | P | P | P | P | |||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | P | P | P | P | P | P | |||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | |||
| Intravascular | |||||||||
| Other (Specify) ** | P | P | P | P | P | P | |||
| Adult Cardiac | P | P | P | P | P | P | P | ||
| Pediatric Cardiac | P | P | P | P | P | P | |||
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | ||
| vascular | Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]:PDI: Power Doppler Imaging , DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
4
U50 with C352UB 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] | |
| General | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | P | P | P | P | P | P | ||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
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+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
5
U50 with L1042UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | ||
| Fetal | ||||||||
| Imaging | Neonatal Cephalic | |||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | |
| vascular | Other (Specify) |
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 Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Prescription Use (Per 21 CFR 801.109)
6
U50 with L742UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | ||
| (Specify) [1] | Other | ||||||||
| (Specify) [2][3] | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / Obstetrics | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | P | ||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | P | ||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| Adult Cardiac | |||||||||
| Pediatric Cardiac | |||||||||
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheral | |||||||||
| vascular | Peripheral vascular | P | P | P | P | P | P | P | |
| Other (Specify) |
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+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
7
U50 with E612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows. | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | ||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | P | P | P | P | P | P | ||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
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+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
5 / 12
8
U50 with C612UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Adult Cardiac | ||||||||
| Cardiac | Pediatric Cardiac | P | P | P | P | P | P | |
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
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+PDV/DPDI, B+Color+PW, B+PDV/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
U50 with C6152UB Transducer
9
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P | ||
| Small Organ (Specify) * | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | P | P | P | P | P | P | ||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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 Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
U50 with C422UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
10
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | Other | |
| (Specify) [1] | (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal / Obstetrics | |||||||||
| Abdominal | P | P | P | P | P | P | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro logical) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) * | |||||||||
| Fetal | |||||||||
| Imaging | Neonatal Cephalic | ||||||||
| Adult Cephalic | |||||||||
| & Other | Trans-rectal | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) ** | |||||||||
| Adult Cardiac | P | P | P | P | P | P | |||
| Cardiac | Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra- cardiac | |||||||||
| Peripheral | Peripheral vascular | ||||||||
| vascular | Other (Specify) |
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 Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
Diagnostic Ultrasound Indications for Use Form
U50 with L552UB Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
| Mode of Operation |
|---|
| ------------------------------------------- |
11
Special 510(k) Submission of U50 Diagnostic Ultrasound System
| General | Specific | B | M | PW | CW | Color | Combined | Other
(Specify) [2][3] |
|-----------------------------|---------------------------------|---|---|----|----|-------|---------------|---------------------------|
| Ophthalmic | Ophthalmic | | | | | | (Specify) 1] | |
| | Fetal / Obstetrics | | | | | | | |
| Fetal
Imaging
& Other | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | b | P | | P | P | P |
| | Small Organ (Specify) * | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Musculo-skeletal(Conventional) | P | P | P | | P | P | P |
| | Musculo-skeletal (Superficial) | P | P | P | | P | P | P |
| | Intravascular | | | | | | | |
| | Other (Specify) ** | | | | | | | |
| | Adult Cardiac | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |
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+PDV/DPDI, B+Color+PW, B+PDV/DPDI +PW
Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Prescription Use (Per 21 CFR 801.109)
12
U50 with C5-2b Transducer
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||
|---|---|---|
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | ||||||||
| Fetal | ||||||||
| Imaging | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| & Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) ** | P | P | P | P | P | P | ||
| Adult Cardiac | ||||||||
| Pediatric Cardiac | ||||||||
| Cardiac | Intravascular(Cardiac) | |||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | |||||||
| vascular | Other (Specify) |
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+PDV/DPDI, B+Color+PW, B+PDV/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
13
U50 with P5-1b Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal / Obstetrics | |||||||
| Abdominal | ||||||||
| 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) ** | ||||||||
| Cardiac | Adult Cardiac | P | P | P | P | P | P | P |
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | ||||||||
| vascular | Peripheral vascular | |||||||
| Other (Specify) |
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+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW * Small Organ includes Thyroid, Testes, Breast Note
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
14
U50 with L15-7b Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PW | CW | Color | Combined | |
| (Specify) [1] | Other | |||||||
| (Specify) [2][3] | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal / Obstetrics | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro logical) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) * | P | P | P | P | P | P | ||
| Fetal | Neonatal Cephalic | |||||||
| Imaging | ||||||||
| & Other | Adult Cephalic | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | ||
| Intravascular | ||||||||
| Other (Specify) ** | ||||||||
| Cardiac | Adult Cardiac | |||||||
| Pediatric Cardiac | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | ||||||||
| Intra- cardiac | ||||||||
| Peripheral | Peripheral vascular | P | P | P | P | P | P | |
| vascular | Other (Specify) |
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+PDV/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
** Other use includes Urology, Gynecology
[1]: PDI: Power Doppler Imaging ,DPDI: Directional Power Doppler Imaging
[2]: Biopsy Guidance
[3]: Harmonic Imaging, This feature does not use contrast agent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
15
510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc. | |||
|---|---|---|---|---|
| #15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen, 518122 P.R.China. | ||||
| Tel.: (0755) 28340011 | ||||
| Fax: +1 (408) 418-4059 | ||||
| Contact Person: | Alice Yang | |||
| Date prepared: | September 20, 2017 | |||
| 2. Device name | ||||
| and classification: | Device Name: U50 Diagnostic Ultrasound System | |||
| Model: U50 | ||||
| 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 | ||||
| 3.Premarket | ||||
| Notification Class | ||||
| III Certification | ||||
| and Summary | Not applicable, the subject device is Class II. | |||
| 4. Predicate | ||||
| Device(s): | U50 Diagnostic ultrasound system/ K142511/ Edan Instruments, Inc. | |||
| 5. Pre-Submission, | ||||
| IDE | Not applicable, there is no prior submission. |
16
| 6. Device
Description: | The U50 is a portable Diagnostic Ultrasound System, which applies
advanced technologies. Various image parameter adjustments, 12.1 inch
LCD and diverse probes are configured to provide clear and stable
images.
The R2.2 version of the U50 utilizes the Linux operating system, which
enables additional printer drivers and the inclusion of an USB DVD
drive. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7. Intended Use: | The diagnostic ultrasound system (U50) is applicable for adults,
pregnant women, pediatric patients' ultrasound evaluation in hospitals
and clinics. It is intended for use in abdominal, obstetrics, gynecology,
pediatric, small parts, urology, peripheral vascular, musculoskeletal
(conventional and superficial), endovaginal and cardiac clinical
applications, by or on the order of a physician or similarly qualified
health care professional. |
9. Predicate Device Comparison
Comparison to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following tables:
| Item | U50 R2.2 Diagnostic
Ultrasound System
(Edan Instruments) | U50 R2.0 Diagnostic
Ultrasound System
(Edan Instruments) | Comparison
Result | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------|
| 510(k)
Number | Current Submission | K142511 | | |
| Manufacturer | EDAN Instruments | EDAN Instruments | Same | |
| Intended Use | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Same | |
| Indications
for Use | The diagnostic ultrasound system
(U50) is applicable for adults,
pregnant women, pediatric
patients' ultrasound evaluation in
hospitals and clinics. It is
intended for use in abdominal,
obstetrics, gynecology, pediatric,
small parts, urology, peripheral
vascular, musculoskeletal
(conventional and superficial),
endovaginal and cardiac clinical
applications, by or on the order
of a physician or similarly
qualified health care
professional. | The diagnostic ultrasound system
(U50) is applicable for adults,
pregnant women, pediatric
patients' ultrasound evaluation in
hospitals and clinics. It is
intended for use in abdominal,
obstetrics, gynecology, pediatric,
small parts, urology, peripheral
vascular, musculoskeletal
(conventional and superficial),
endovaginal and cardiac clinical
applications, by or on the order
of a physician or similarly
qualified health care
professional. | Same | |
| Installation
and Use | a. Portable Equipment
b. Mobile Equipment (when the
system is installed on the mobile
trolley) | a. Portable Equipment
b. Mobile Equipment (when the
system is installed on the mobile
trolley) | Same | |
| | | | | |
| Safety
Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10
AIUM, NEMA UD 2, UD3 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-37
ISO 10993-1, -5, -10
AIUM, NEMA UD 2, UD3 | Same | |
| Patient
Contact
Materials | Complies with ISO 10993 | Complies with ISO 10993 | Same | |
| Software
life
cycle
processes | Complies with the standard: IEC
62304 | Complies with the standard: IEC
62304 | Same | |
| Mode
of
Operations | Continuous operation | Continuous operation | Same | |
| General
Imaging mode | B-Mode,
M-Mode,
Color,
PDI/DPDI, PW, CW | B-Mode,
M-Mode,
Color,
PDI/DPDI, PW, CW | Same | |
| Measurements | B-Mode:
Distance,
Area,
Volume, Ratio, Histogram and
Angle
M-Mode: Distance, Time, Slope,
and Heart Rate
D-Mode: Time, Heart
Rate.
Velocity, Acceleration, RI, PI and
Auto (auto trace) | B-Mode:
Distance,
Area,
Volume, Ratio, Histogram and
Angle
M-Mode: Distance, Time, Slope,
and Heart Rate
D-Mode: Time,
Heart
Rate.
Velocity, Acceleration, RI, PI and
Auto (auto trace) | Same | |
| Scanning
method | Electronic convex
Electronic
linear
with
slant
scanning | Electronic convex
Electronic
linear
with
slant
scanning | Same | |
| Cine loop | 1227 frames | 1227 frames | Same | |
| Focus
Number | Max=4 | Max=4 | Same | |
| Software
Packages | Abdomen, obstetric, small parts,
gynecology, cardiology, urology,
vascular and Pediatrics. | Abdomen, obstetric, small parts.
gynecology, cardiology, urology,
vascular and Pediatrics. | Same | |
| Principle
of
Operation | Applying high voltage burst to
the Piezoelectric material in the
transducer and detect reflected
echo to construct diagnostic
image | Applying high voltage burst to
the Piezoelectric material in the
transducer and detect reflected
echo to construct diagnostic
image | Same | |
| Acoustic
Output | Track 3: MI, TIS, TIC, TIB(TI
Range 0-6.0)
Derated ISPTA: 720 W/cm²
maximum, Mechanic Index ≤1.9
maximum or Derated ISPPA 190
W/cm² max | Track 3: MI, TIS, TIC, TIB(TI
Range 0-6.0)
Derated ISPTA: 720 W/cm²
maximum, Mechanic Index ≤1.9
maximum or Derated ISPPA 190
W/cm2 max | Same | |
| Transducer
Types | Convex Array
Linear Array
Micro Convex Array
Phased Array | Convex Array
Linear Array
Micro Convex Array
Phased Array | Same | |
| Transducer
Frequency | 2.0-15.0 MHz | 2.0-15.0 MHz | Same | |
| | | | | |
| Primary
Display | Primary Screen:
12.1inch(1024768) | Primary Screen:
12.1inch(1024768) | Same | |
| Ports | | | | |
| Dimensions/
Weight | 330 mm (W) × 320 mm (L) ×
220 mm (H)
net weight 7.8kg | 330 mm (W) × 320 mm (L) ×
220 mm (H)
net weight 7.8kg | Same | |
| Printer | B/W video thermal printer
Color video thermal printer
Graph/text laser jet printer | B/W video thermal printer
Color video thermal printer
Graph/text laser jet printer | Same | |
| Storage
Media | DVD, USB stick | USB stick | Difference | |
| Temperature | Operating: 5°C 40°C55°C | Operating: 5°C
Transport/ Storage: -2040°C55°C | Same | |
Transport/ Storage: -20
| Relative
humidity | Operating: 25% ~ 80%RH (no
condensation)
Transport/ Storage: 25% ~
93%RH (no condensation) | Operating: 25% ~ 80%RH (no
condensation)
Transport/ Storage: 25% ~
93%RH (no condensation) | Same | |
| Atmospheric
pressure | Operating: 860hPa ~1060hPa
Transport/ Storage: 700hPa
~1060hPa | Operating: 860hPa ~1060hPa
Transport/ Storage: 700hPa
~1060hPa | Same | |
| Power
Requirements | AC: 100-240V 50/60Hz | AC: 100-240V 50/60Hz | Same | |
| Operation
System | Linux | µCosII | Difference | |
| Safety Classifications | | | | |
| Type
of
protection
against
electric shock | Class I | Class I | Same | |
| The degree of
protection
against
electric shock | Type BF. | Type BF. | Same | |
| The degree of
protection
against
harmful
ingress
of
liquid | The main unit : IPX0,
probes : IPX7
Footswitch: IP68 | The main unit : IPX0,
probes : IPX7
Footswitch: IP68 | Same | |
| The degree of
safety of
application in
the
presence
of
a
flammable
gas | Equipment not suitable for use in
the presence of a flammable gas | Equipment not suitable for use in
the presence of a flammable gas | Same | |
| The degree of
RF | Group 1, Class A | Group 1, Class A | Same | |
| Disinfection | | | | |
| Disinfection | Probe:
2.4%Glutaraldehyde,
0.55%Ortho-Phthalaldehyde.
Needle guide:
75% medical alcohol. | Probe:
2.4%Glutaraldehyde,
0.55%Ortho-Phthalaldehyde.
Needle guide:
75% medical alcohol. | Same | |
| | 2.4%Glutaraldehyde. | 2.4%Glutaraldehyde. | | |
| Performance | | | | |
| Displayed depth | 20-320mm (Probe Dependent) | 20-320mm (Probe Dependent) | Same | |
| Gray Scales | 256 | 256 | Same | |
| Dynamic range | 150dB | 150dB | Same | |
| TGC | 8 segments | 8 segments | Same | |
| Zoom | Up to 400% | Up to 400% | Same | |
| Image Adjustments | | | | |
| | Image type | Image type | Same | |
| | Gain | Gain | | |
| | Depth | Depth | | |
| | TGC | TGC | | |
| | Freq(Frequency) | Freq(Frequency) | | |
| | Gray Map | Gray Map | | |
| | Dynamic Range | Dynamic Range | | |
| | Rejection | Rejection | | |
| | Focus Position | Focus Position | | |
| | Focus Number | Focus Number | | |
| B Mode
Parameters | eSRI(Spackle Imaging) | eSRI(Spackle Imaging) | | |
| | Rejection | Rejection | | |
| | Pseudo color | Pseudo color | | |
| | Spatial Compound | Spatial Compound | | |
| | | GAO(Gain Auto Optimization) | GAO(Gain Auto Optimization) | |
| | | Scan Angle | Scan Angle | |
| | | Scan Mode | Scan Mode | |
| | | Frame Persist | Frame Persist | |
| | H Reverse(horizontal) | H Reverse(horizontal) | Same | |
| | V Reverse(vertical) | V Reverse(vertical) | | |
| | 90°Rotate | 90°Rotate | | |
| | B/W Invert | B/W Invert | | |
| M Mode
Parameters | Freq | Freq | | |
| | | Sweep Speed | | |
| | | Display Layout | | |
| | | Gray Map | | |
| | | Focus Position | Focus Position | |
| | | Dynamic Range | Dynamic Range | |
| | | Pseudo Color | Pseudo Color | |
| | | Line Average | Line Average | |
| | Flow type | Flow type | Same | |
| | Gain | Gain | | |
| Color Mode
& Power
Doppler Mode
&
Directional
Power Mode
Parameters | Freq | Freq | | |
| | | Wallfilter | | |
| | | PRF(Pulsed Frequency) | | |
| | Repetition | Repetition | | |
| | | Base Line | | |
| | | Invert | | |
| | | Dual Live | Dual Live | |
| | | Angle Steer | Angle Steer | |
| | | | | |
| | Packet size | Packet size | Same | |
| | Persist | Persist | | |
| | Threshold | Threshold | | |
| | Smooth Filter | Smooth Filter | | |
| | ROI box position and size | ROI box position and size | | |
| | adjustment | adjustment | | |
| | Flow type | Flow type | | |
| | Gain | Gain | | |
| | PRF | PRF | | |
| | Invert | Invert | | |
| | Angle steer | Angle steer | | |
| | Correction Angle | Correction Angle | | |
| | Quick Angle | Quick Angle | | |
| | Base Line | Base Line | | |
| | Sample Volume | Sample Volume | | |
| PW
Mode
Parameters | Wallfilter | Wallfilter | | |
| | | Freq | | |
| | | Duplex and Triplex | | |
| | | Pseudo Color | | |
| | | Dyn Rng | | |
| | | Volume | | |
| | | Sweep Speed | Sweep Speed | |
| | | HPRF | HPRF | |
| | | Flow type | Flow type | |
| | | Gain | Gain | |
| | | PRF | PRF | |
| | | Invert | Invert | |
| | | Angle steer | Angle steer | |
| | | Correction Angle | Correction Angle | |
| | CW
Mode
Parameters | Quick Angle | Quick Angle | |
| | | | Base Line | |
| | | | Wallfilter | |
| | | | Pseudo Color | |
| | | | Dynamic Range | |
| | | | Volume | |
| | | | Sweep Speed | |
| B-Mode Measurement Accuracy | | | | |
| Range of
Depth/
Distance | | Maximum 324 mm | Maximum 324 mm | |
| Accuracy of
Depth/
Distance | | $\leq$±5% | $\leq$±5% | |
| Range of Area | | Maximum 1126 cm2 | Maximum 1126 cm2 | |
| Accuracy of
Area | | $\leq$±10% | $\leq$±10% | |
| Range of
Angle | | 0-180° | 0-180° | |
| Accuracy of
Angle | $\leq$±3% | $\leq$±3% | Same | |
| Range of | Maximum 1.0 | Maximum 1.0 | Same | |
| Ratio | | | | |
| Accuracy of Ratio | | $ \leq $ ±10% | $ \leq $ ±10% | Same |
| Range of Volume | | Maximum 999 cm³ | Maximum 999 cm³ | Same |
| Accuracy of Volume | | $ \leq $ ±15% | $ \leq $ ±15% | Same |
| M-mode Measurement Accuracy | | | | |
| Range of Depth | | Maximum 324mm | Maximum 324mm | Same |
| Accuracy of Depth | | $ \leq $ ±5% | $ \leq $ ±5% | Same |
| Range of Time | | Maximum 13s | Maximum 13s | Same |
| Accuracy of Time | | $ \leq $ ±5% | $ \leq $ ±5% | Same |
| Range of Heart rate | | Maximum 999bpm | Maximum 999bpm | Same |
| Accuracy of Heart rate | | $ \leq $ ±5% | $ \leq $ ±5% | Same |
| Range of Slope | | Maximum 999mm/s | Maximum 999mm/s | Same |
| Accuracy of Slope | | $ \leq $ ±10% | $ \leq $ ±10% | Same |
| PW mode velocity Measurement Accuracy | | | | |
| Range | | 0.5-2.5m/s | 0.5-2.5m/s | Same |
| Accuracy | | $ \leq $ ±10% | $ \leq $ ±10% | Same |
| CW mode velocity Measurement Accuracy | | | | |
| Range | | 0.5-2.5m/s | 0.5-2.5m/s | Same |
| Accuracy | | $ \leq $ ±10% | $ \leq $ ±10% | Same |
17
18
19
20
21
The subject device has same intended use, similar product design, and same performance effectiveness, as the predicate device. There are no significant differences between the primary predicate. There are no new questions of safety and/or effectiveness. There are no changes to the intended use, indications for use, nor fundamental scientific technology.
10. Effectiveness and Safety Considerations:
Clinical test:
Clinical testing is not required.
Non-clinical test: The U50 Ultrasound Imaging System complies with:
(1) IEC 60601-1:2005/A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (2) IEC 60601-1-2 Edition 3:2007-03, medical electrical equipment - part 1-2: general
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requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
(3) IEC 60601-2-37 Edition 2.0 2007, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
(4) NEMA UD 3, Edition 2004 Standard for real-time display of thermal and mechanical acoustic output Indies on diagnostic ultrasound equipment.
(5) Acoustic output testing as per the guideline "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated September 9, 2008.
(6) NEMA, UD2, Edition 2004 for acoustic output measurement methodology.
The following biocompatibility standards are conducted on the subject device: (1) ISO 10993-1:2009, ISO 10993-5:2009 and ISO 10993-10:2010
The tests were selected to show substantial equivalence between the subject device and the predicate.
11. Substantially Equivalent Determination
Verification and validation testing has been conducted on the U50 Ultrasound Imaging System. This premarket notification submission demonstrates that U50 Ultrasound Imaging System is substantially equivalent to the predicate devices.