LogoFDA 510(k) Search
K Number
K180408
Device Name
U60 Diagnostic Ultrasound System
Manufacturer
Edan Instruments, Inc.
Date Cleared
2018-04-13

(58 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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 Description
The U60 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 15.0 inch LCD and diverse probes are configured to provide clear and stable images.
More Information

K173003

Not Found

No
The document does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.

No
The device is described as a "Diagnostic Ultrasound System" and its intended use is for "ultrasound evaluation" in various clinical applications. There is no mention of treating or alleviating a condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that "The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics." Additionally, the "Device Description" 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 "15.0 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 Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Function: The description clearly states this is a "Diagnostic Ultrasound System." Ultrasound systems use sound waves to create images of internal body structures. They do not analyze specimens taken from the body.
  • Intended Use: The intended use describes imaging various anatomical sites within the body.
  • Device Description: The description focuses on the technical aspects of the ultrasound system itself (LCD, probes, image adjustments).

Therefore, based on the provided information, this device falls under the category of imaging devices rather than In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

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.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Product codes

IYN, IYO, ITX

Device Description

The U60 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 15.0 inch LCD and diverse probes are configured to provide clear and stable images.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac.

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

Clinical testing is not required.
Non-clinical test:
The U60 Diagnostic Ultrasound System complies with:

  • (1) ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
  • (2) I IEC 60601-1-2:2014: 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.
    Verification and validation testing has been conducted on the U60 Ultrasound Imaging System. This premarket notification submission demonstrates that U60 Ultrasound Imaging System is substantially equivalent to the predicate devices.

Key Metrics

Not Found

Predicate Device(s)

U50 Diagnostic ultrasound system/ K173003/ Edan Instruments, Inc.

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

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.

Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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EF

Type of Use (Select one or both, as applicable)

3

Clinical ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal / ObstetricsPPPPPP
AbdominalPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
PediatricPPPPPP
Small Organ (Specify) *PPPPPP
Fetal
Imaging
& OtherNeonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginalPPPPPP
Trans-urethral
Musculo-skeletal(Conventional)PPPPPP
Musculo-skeletal (Superficial)PPPPPP
Intravascular
Other (Specify) **PPPPPP
Adult CardiacPPPPPPP
Pediatric CardiacPPPPPP
CardiacIntravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral vascularPPPPPP
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)

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| Clinical Application | | Mode of Operation | B | M | PW | CW | Color | Combined
(Specify) [1] | Other
(Specify) [2][3] |
|-----------------------------|---------------------------------|-------------------|---|---|----|----|-------|---------------------------|---------------------------|
| General | Specific | | | | | | | | |
| | Ophthalmic | Ophthalmic | | | | | | | |
| Fetal
Imaging
& 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
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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal
Imaging
& OtherFetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
Pediatric
Small Organ (Specify) *PPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal (Conventional)PPPPPP
Musculo-skeletal (Superficial)PPPPPP
Intravascular
Other (Specify) **
CardiacAdult Cardiac
Pediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral vascularPPPPPP
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 ApplicationMode of Operation
SpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
Pediatric
Small Organ (Specify) *PPPPPP
Fetal
Imaging
& OtherNeonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal(Conventional)PPPPPP
Musculo-skeletal (Superficial)PPPPPP
Intravascular
Other (Specify) **
CardiacAdult Cardiac
Pediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
PeripheralPeripheral vascularPPPPPP
vascularOther (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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal / ObstetricsPPPPPP
Fetal
Imaging
& OtherAbdominal
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
Pediatric
Small Organ (Specify) *
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginalPPPPPP
Trans-urethral
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify) **
CardiacAdult Cardiac
Pediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral 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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal
Imaging
& OtherFetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
PediatricPPPPPP
Small Organ (Specify) *
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify) **
CardiacAdult Cardiac
Pediatric CardiacPPPPPP
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral 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 ApplicationMode of Operation
SpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
GeneralOphthalmic
Fetal
Imaging
& OtherFetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
PediatricPPPPPPP
Small Organ (Specify) *
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify) **
Adult Cardiac
CardiacPediatric CardiacPPPPPPP
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral 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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal / Obstetrics
AbdominalPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
Pediatric
Small Organ (Specify) *
Fetal
Imaging
& OtherNeonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify) **
CardiacAdult CardiacPPPPPPP
Pediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
PeripheralPeripheral vascular
vascularOther (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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
PediatricPPPPPPP
Small Organ (Specify) *PPPPPPP
Fetal
Imaging
& OtherNeonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal(Conventional)PPPPPPP
Musculo-skeletal (Superficial)PPPPPPP
Intravascular
Other (Specify) **
Adult Cardiac
CardiacPediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
PeripheralPeripheral vascularPPPPPPP
vascularOther (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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal / ObstetricsPPPPPP
AbdominalPPPPPP
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
Pediatric
Small Organ (Specify) *
Fetal
Imaging
& OtherNeonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify) **PPPPPP
CardiacAdult Cardiac
Pediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral 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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal
Imaging
& OtherFetal / 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) **
CardiacAdult CardiacPPPPPPP
Pediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral 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 ApplicationMode of Operation
GeneralSpecificBMPWCWColorCombined
(Specify) [1]Other
(Specify) [2][3]
OphthalmicOphthalmic
Fetal
Imaging
& OtherFetal / Obstetrics
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro logical)
Laparoscopic
Pediatric
Small Organ (Specify) *PPPPPPP
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skeletal(Conventional)PPPPPP
Musculo-skeletal (Superficial)PPPPPP
Intravascular
Other (Specify) **
CardiacAdult Cardiac
Pediatric Cardiac
Intravascular(Cardiac)
Trans-esoph.(Cardiac)
Intra- cardiac
Peripheral
vascularPeripheral vascularPPPPPP
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
and classification:Device Name: U60 Diagnostic Ultrasound System
Model: U60
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 SummaryNot applicable, the subject device is Class II.
4. Predicate
Device(s):U50 Diagnostic ultrasound system/ K173003/ Edan Instruments, Inc.
5. Pre-Submission,
IDENot applicable, there is no prior submission.

16

    1. 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
Ultrasound System
(Edan Instruments) | U50 R2.2
Ultrasound System
(Edan Instruments) | Comparison
Result | |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------|
| 510(k)
Number | Current Submission | K173003 | | |
| 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
(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. | 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 | B-Mode: Distance, Area,
Volume, Ratio, Histogram and
Angle | Same | |
| | M-Mode: Distance, Time, Slope,
and Heart Rate | M-Mode: Distance, Time, Slope,
and Heart Rate | | |
| | D-Mode: Time, Heart Rate,
Velocity, Acceleration, RI, PI and
Auto (auto trace) | D-Mode: Time, Heart Rate,
Velocity, Acceleration, RI, PI and
Auto (auto trace) | | |
| | | | | |
| 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:
15inch(1024768) | Primary Screen:
12.1inch(1024768) | Difference | |
| Ports | | | | |
| Dimensions/
Weight | 220 mm (W) × 370 mm (L) ×350
mm (H)
net weight 8.1kg | 330 mm (W) × 320 mm (L) ×
220 mm (H)
net weight 7.8kg | Difference | |
| 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 | DVD, USB stick | Same | |
| Temperature | Operating: 0°C 40°C
Transport/ Storage: -2055°C | Operating: 5°C 40°C
Transport/ Storage: -2055°C | Difference | |
| Relative
humidity | Operating: 15% ~ 95%RH (no
condensation)
Transport/
Storage:
15% ~
95%RH (no condensation) | Operating: 25% ~ 80%RH (no
condensation)
Transport/
Storage:
25% ~
93%RH (no condensation) | Difference | |
| 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 | Linux | Same | |
| 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 | | |
| | 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) Rejection | eSRI(Spackle
Imaging) Rejection | Same | |
| | 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) | | |
| | V Reverse(vertical) | V Reverse(vertical) | | |
| | 90°Rotate | 90°Rotate | | |
| | B/W Invert | B/W Invert | | |
| | Freq | Freq | | |
| | Sweep Speed | Sweep Speed | | |
| | Display Layout | Display Layout | | |
| M Mode
Parameters | Gray Map | Gray Map | Same | |
| | Focus Position | Focus Position | | |
| | Dynamic Range | Dynamic Range | | |
| | Pseudo Color | Pseudo Color | | |
| | Line Average | Line Average | | |
| | Flow type | Flow type | | |
| | Gain | Gain | | |
| Color Mode
& Power | Freq | Freq | | |
| | Wallfilter | Wallfilter | | |
| Doppler
Mode &
Directional
Power Mode
Parameters | PRF(Pulsed
Frequency) Repetition | PRF(Pulsed
Frequency) Repetition | Same | |
| | Base Line | Base Line | | |
| | Invert | Invert | | |
| | Dual Live | Dual Live | | |
| | Angle Steer | Angle Steer | | |
| | Packet size | Packet size | | |
| | 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 | Same | |
| | Invert | Invert | | |
| | Angle steer | Angle steer | | |
| | Correction Angle | Correction Angle | | |
| | Quick Angle | Quick Angle | | |
| PW
Mode
Parameters | Base Line | Base Line | | |
| | Sample Volume | Sample Volume | Same | |
| | Wallfilter | Wallfilter | | |
| | Freq | Freq | | |
| | Duplex and Triplex | Duplex and Triplex | | |
| | Pseudo Color | Pseudo Color | | |
| | Dyn Rng | Dyn Rng | | |
| | Volume | Volume | | |
| | Sweep Speed | Sweep Speed | | |
| | HPRF | HPRF | | |
| | Flow type | Flow type | Same | |
| | Gain | Gain | | |
| | PRF | PRF | | |
| | Invert | Invert | | |
| | Angle steer | Angle steer | | |
| CW
Mode
Parameters | Correction Angle | Correction Angle | | |
| | Quick Angle | Quick Angle | | |
| | Base Line | Base Line | | |
| | | Wallfilter | Wallfilter | |
| | | Pseudo Color | Pseudo Color | |
| | | Dynamic Range | Dynamic Range | |
| | Volume | Volume | | |
| | Sweep Speed | Sweep Speed | | |
| B-Mode Measurement Accuracy | | | | |
| Range
of
Depth/
Distance | Maximum 324 mm | Maximum 324 mm | Same | |
| Accuracy
of
Depth/
Distance | ≤±5% | ≤±5% | Same | |
| Range of Area | Maximum 1126 cm² | Maximum 1126 cm² | Same | |
| Accuracy
of
Area | ≤±10% | ≤±10% | Same | |
| Range
of
Angle | 0-180° | 0-180° | Same | |
| Accuracy
of
Angle | ≤±3% | ≤±3% | Same | |
| Range
of | Maximum 1.0 | Maximum 1.0 | Same | |
| Ratio | | | | |
| Accuracy of Ratio | | $