U60 Diagnostic Ultrasound System
Device Facts
| Record ID | K180408 |
|---|---|
| Device Name | U60 Diagnostic Ultrasound System |
| Applicant | Edan Instruments, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 13, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The diagnostic ultrasound system (U60) 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.
Device Story
Portable diagnostic ultrasound system; inputs ultrasound signals via various transducers; transforms signals using piezoelectric technology to construct diagnostic images; outputs images on 15-inch LCD; used in hospitals/clinics by physicians/qualified professionals; supports B, M, PW, CW, Color, Power Doppler, and Directional Power Doppler modes; assists in clinical decision-making through visualization and measurement of anatomy/fluid flow; benefits patients via non-invasive diagnostic imaging.
Clinical Evidence
No clinical data; bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, and ISO 10993 biocompatibility standards demonstrated substantial equivalence.
Technological Characteristics
Portable ultrasound system; 15-inch LCD; piezoelectric transducers (convex, linear, micro-convex, phased array); frequency range 2.0-15.0 MHz; Linux-based OS; connectivity via USB/DVD; IPX0 main unit, IPX7 probes, IPX8 footswitch; complies with IEC 60601-1, 60601-1-2, 60601-2-37, NEMA UD 2/3, ISO 10993.
Indications for Use
Indicated for ultrasound evaluation of adults, pregnant women, and pediatric patients in hospitals and clinics. Applications include abdominal, obstetrics, gynecology, pediatric, small parts (thyroid, testes, breast), urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal, and cardiac. Used by or on the order of a physician or qualified healthcare professional.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- U50 Diagnostic ultrasound system (K173003)
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- K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
- K212900 — MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 5, 2021
- K130659 — SPEQRT ULTRASOUND SYSTEM · Signostics Pty, Ltd. · Apr 3, 2013
- K223570 — SonoAir Series Digital Color Doppler Ultrasound System · CHISON Medical Technologies Co., Ltd. · Mar 31, 2023
Submission Summary (Full Text)
{0}------------------------------------------------
April 13, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Edan Instruments, Inc. % Mr. Doug Worth Sr. Dir. US RA/QA Edan Medical 1200 Crossman Avenue, Suite 200 SUNNYVALE CA 94089
Re: K180408
Trade/Device Name: U60 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: March 28, 2018 Received: April 2, 2018
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 mediation-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)
K180408
Device Name
U60 Diagnostic Ultrasound System
#### Indications for Use (Describe)
The diagnostic ultrasound system (U60) 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.
| <span style="text-decoration: underline;"></span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
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EF
Type of Use (Select one or both, as applicable)
{3}------------------------------------------------
| | Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|---|-------------------|----|----|-------|---------------------------|---------------------------|--|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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 | P | P | P | | P | P | P | |
| | Small Organ (Specify) * | P | P | P | | P | P | P | |
| Fetal<br>Imaging<br>& 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<br>vascular | Peripheral vascular | P | P | P | | P | P | P | |
| | Other (Specify) | | | | | | | | |
#### U60 Diagnostic Ultrasound System
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)
{4}------------------------------------------------
| Clinical Application | | Mode of Operation | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
|-----------------------------|---------------------------------|-------------------|---|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | | | | | | | | |
| | Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | 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) * | | | | | | | | |
| | 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 |
| Cardiac | Adult Cardiac | | | | | | | | |
| | Pediatric Cardiac | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra- cardiac | | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | | |
| | Other (Specify) | | | | | | | | |
#### U60 with C352UB Transducer
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 * 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)
{5}------------------------------------------------
| 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<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | 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) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | P | P | P | | P | P | P |
| | Other (Specify) | | | | | | | |
#### U60 with L1042UB Transducer
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)
{6}------------------------------------------------
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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<br>Imaging<br>& Other | 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) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | | P | P | P |
| vascular | Other (Specify) | | | | | | | |
#### U60 with L742UB Transducer
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)
{7}------------------------------------------------
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | P | P | P | | P | P | P |
| Fetal<br>Imaging<br>& Other | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | | | | | | | |
| | 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) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
#### U60 with E612UB Transducer
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 * 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)
{8}------------------------------------------------
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
#### U60 with C612UB Transducer
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 * 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)
{9}------------------------------------------------
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| General | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | 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 | P |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
#### U60 with C6152UB Transducer
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)
{10}------------------------------------------------
| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|---------------------------------|---|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(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<br>Imaging<br>& Other | 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 | Peripheral vascular | | | | | | | |
| vascular | Other (Specify) | | | | | | | |
#### U60 with C422UB Transducer
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)
{11}------------------------------------------------
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P |
| | Small Organ (Specify) * | P | P | P | P | P | P | P |
| Fetal<br>Imaging<br>& 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 | | | | | | | |
| Cardiac | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral | Peripheral vascular | P | P | P | P | P | P | P |
| vascular | Other (Specify) | | | | | | | |
#### U60 with L552UB Transducer
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 * 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)
{12}------------------------------------------------
### U60 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<br>(Specify) [1] | Other<br>(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<br>Imaging<br>& 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 |
| Cardiac | | Adult Cardiac | | | | | | | |
| | | Pediatric Cardiac | | | | | | | |
| | | Intravascular(Cardiac) | | | | | | | |
| | | Trans-esoph.(Cardiac) | | | | | | | |
| | | Intra- cardiac | | | | | | | |
| Peripheral<br>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+PDI/DPDI, B+Color+PW, B+PDI/DPDI +PW Note * Small Organ includes Thyroid, Testes, Breast
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 | |
| CAST THE CONSTITUTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO | |
[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)
{13}------------------------------------------------
| | Clinical Application | Mode of Operation | | | | | | |
|-----------------------------|---------------------------------|-------------------|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | B | M | PW | CW | Color | Combined<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& 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<br>vascular | Peripheral vascular | | | | | | | |
| | Other (Specify) | | | | | | | |
#### U60 with P5-1b Transducer
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 * 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)
{14}------------------------------------------------
#### U60 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<br>(Specify) [1] | Other<br>(Specify) [2][3] |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetal / Obstetrics | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro logical) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) * | P | 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) ** | | | | | | | |
| Cardiac | Adult Cardiac | | | | | | | |
| | Pediatric Cardiac | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | |
| | Intra- cardiac | | | | | | | |
| Peripheral<br>vascular | Peripheral vascular | 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+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)
{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) 26858736 | | | | |
| | Fax: +1 (408) 418-4059 | | | | |
| Contact Person: | Crystal Cai | | | | |
| Date prepared: | February 12, 2018 | | | | |
| 2. Device name<br>and classification: | Device Name: U60 Diagnostic Ultrasound System | | | | |
| | Model: U60 | | | | |
| | Classification Name: | | | | |
| | 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic<br>Product code: IYN | | | | |
| | 892.1560 Ultrasonic, Pulsed echo, Imaging<br>Product code: IYO | | | | |
| | 892.1570 Transducer, Ultrasonic, Diagnostic<br>Product code: ITX | | | | |
| | Regulatory Class: Class II | | | | |
| 3.Premarket<br>Notification Class<br>III Certification<br>and Summary | Not applicable, the subject device is Class II. | | | | |
| 4. Predicate<br>Device(s): | U50 Diagnostic ultrasound system/ K173003/ Edan Instruments, Inc. | | | | |
| 5. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. | | | | |
{16}------------------------------------------------
- 6. Device The U60 is a portable Diagnostic Ultrasound System, which applies Description: advanced technologies. Various image parameter adjustments, 15.0 inch LCD and diverse probes are configured to provide clear and stable images.
- The diagnostic ultrasound system (U60) is applicable for adults, 7. Intended Use: 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 | U60 R1.0<br>Ultrasound System<br>(Edan Instruments) | U50 R2.2<br>Ultrasound System<br>(Edan Instruments) | Comparison<br>Result | |
|---…
