X5 Digital Color Doppler Ultrasound System
Device Facts
| Record ID | K160258 |
|---|---|
| Device Name | X5 Digital Color Doppler Ultrasound System |
| Applicant | Sonoscape Medical Corp. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 1, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The SonoScape X5 system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Device Story
Portable, software-controlled, general-purpose color Doppler ultrasound system. Inputs: ultrasonic echo signals from patient body via electrical-acoustical transducers (linear, convex, phased arrays). Processing: system transmits ultrasonic energy, receives echoes, processes signals via delay time/strength analysis, and uses Doppler/autocorrelation technology for blood flow imaging. Outputs: real-time B-mode (including Tissue Harmonic Imaging), M-mode, Color-Flow, Pulsed Wave, Continuous Wave, and Power Doppler images on integrated LCD monitor. Used in clinical settings by physicians for diagnostic imaging and fluid flow analysis. Healthcare providers use displayed images to evaluate organ status and blood flow, aiding clinical diagnosis. Benefits include non-invasive, real-time visualization of internal structures and hemodynamics.
Clinical Evidence
No clinical testing was required. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility, thermal/mechanical safety, biocompatibility, and acoustic output measurements conforming to recognized standards (IEC 60601-1, IEC 60601-2-37, ISO 10993, AIUM/NEMA UD2/UD3).
Technological Characteristics
Portable ultrasound system; embedded Linux OS; supports linear, convex, and phased array transducers. Imaging modes: B, M, PW, CW, Color Doppler, Power Doppler, THI. Connectivity: USB for software updates. Biocompatibility per ISO 10993-5/10. Electrical safety per IEC 60601-1. Acoustic output per AIUM/NEMA UD2/UD3.
Indications for Use
Indicated for use by qualified physicians for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, testes, thyroid), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral/cerebral vascular, musculo-skeletal, cardiac (neonatal/adult), OB/Gyn, and urology applications.
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
- SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System (K152164)
Related Devices
- K163427 — X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Jan 3, 2017
- K201059 — S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Jul 30, 2020
- K170303 — E5 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · May 19, 2017
- K152164 — S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Aug 28, 2015
- K142815 — S22 Digital Color Doppler Ultrasound System · Sonoscape Company Limited · Jan 28, 2015
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
April 4, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SONOSCAPE MEDICAL CORP. % Ms. Toki Wu Regulatory Affairs Manager 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road, Nanshan Shenzhen, GuangDong 518051 CHINA
Re: K160258
Trade/Device Name: X5 Digital Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 22, 2016 Received: February 1, 2016
Dear Ms. Wu:
This letter corrects our substantially equivalent letter of April 1, 2016. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jeff Bollyea
FDA
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)
Device Name
X5 Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoScape X5 system is a general-purpose ultrasonic intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
SonoScape X5 System:
Diagnostic Ultrasound Pulsed Echo System
Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2 |
| | Small Organ (specify) | N | N | N | | N | N | Note 1 | Notes 2,6 |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2 |
| Fetal<br>Imaging&<br>Other | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | Notes 2 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | Note 1 | Notes 2 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2 |
| | Other (Urology) | N | N | N | | N | N | Note 1 | Notes 2 |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| | Peripheral vessel | N | N | N | | N | N | Note 1 | Notes 2 |
| Peripheral<br>Vessel | Cerebral vascular | | | N | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{4}------------------------------------------------
#### Transducer: 3C-A Curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Abdominal | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Other (Urology) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Cerebral vascular | | | | | | | | |
P = previously cleared by FDA; N = new indication; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 5: 4D
Note 4: 3D Note 3: TDI Note 6: Small Organ: breast, thyroid, testes
{5}------------------------------------------------
#### Transducer: C613 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-----------------|-------------------|-----|-----|------------------|---------------------------------|--------------------|-------------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2 | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2 | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Fetal | Adult Cephalic | | | | | | | | | |
| Imaging& | Trans-rectal | | | | | | | | | |
| Other | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | | |
| | | Intra-cardiac | | | | | | | | |
| | | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Cerebral vascular | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{6}------------------------------------------------
#### Transducer: 3P-A Phased Array
#### Diagnostic Ultrasound Transducer
#### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | Note 1 | Notes 2 | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Fetal | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Imaging& | Trans-rectal | | | | | | | | | |
| Other | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2 | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Cerebral vascular | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 5: 4D
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{7}------------------------------------------------
## Transducer: 7P-B Phased Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-----------------|-------------------|-----|-----|------------------|---------------------------------|--------------------|-------------------|--|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative Specify | | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2 | |
| | Small Organ (specify) | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2 | |
| Fetal<br>Imaging& | Adult Cephalic | | | | | | | | | |
| Other | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | | |
| | Other (Urology) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2 | |
| | Intravascular(Cardiac) | | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | | |
| | | Intra-cardiac | | | | | | | | |
| | | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Cerebral vascular | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{8}------------------------------------------------
#### Transducer: L741 Linear Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | N | N | N | N | N | N | Note 1 | Notes 2,6 |
| | Neonatal Cephalic | | | | | | | | |
| Fetal | Adult Cephalic | | | | | | | | |
| Imaging& | Trans-rectal | | | | | | | | |
| Other | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | N | N | N | Note 1 | Notes 2 |
| Vessel | Cerebral vascular | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD;
B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{9}------------------------------------------------
#### Transducer: 6V1 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal | Adult Cephalic | | | | | | | | |
| Imaging& | Trans-rectal | N | N | N | N | N | N | Note 1 | Notes 2 |
| Other | Trans-vaginal | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | N | N | N | N | N | N | Note 1 | Notes 2 |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Cerebral vascular | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THl; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
{10}------------------------------------------------
## Transducer: EC9-5 Micro-curved Array
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal | Adult Cephalic | | | | | | | | |
| Imaging& | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2 |
| Other | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | N | N | N | | N | N | Note 1 | Notes 2 |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Cerebral vascular | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{11}------------------------------------------------
#### Transducer: PWD2.0
Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal | Adult Cephalic | | | N | | | | | |
| Imaging& | Trans-rectal | | | | | | | | |
| Other | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| | Other (Urology) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| Cardiac | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Cerebral vascular | | | N | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
{12}------------------------------------------------
# 510(k) Summary
## 1. Submitter [21 CFR807.92 (a) (1)]
| Submitter: | SONOSCAPE MEDICAL CORP. |
|-----------------|-------------------------------------------------------------------------------------------------------|
| Address: | 4/f, 5/f, 8/f, 9/f & 10/f, Yizhe Building, Yuquan Road,<br>Nanshan, Shenzhen 518051, Guangdong, China |
| Contact Person: | Toki Wu |
| Tel: | +86 755 26722890 |
| Fax: | +86 755 26722850 |
| Email: | ra@sonoscape.net |
| Date Prepared | March 30, 2016 |
## 2. Device [21 CFR807.92 (a) (2)]
| Trade Name: | X5 Digital Color Doppler Ultrasound System |
|--------------|----------------------------------------------|
| Common Name: | Diagnostic Ultrasound System and Transducers |
Classification Regulatory:
| | FR Number | Product Code |
|------------------------------------------|-----------|--------------|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Classification Panel: Radiology Device Class: ll
## 3. Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicate device within this submission is as follows: SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System K152164
## 4. Device Description [21 CFR 807.92(a) (4)]
This SonoScape X5 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The X5 system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the
{13}------------------------------------------------
delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical and acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.
This system consists of keyboard control panel, power supply module, color LCD monitor and optional probes.
This system is a portable, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes.
#### 5. Intended Use [21 CFR 807.92(a) (5)]
The SonoScape X5 system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
#### 6. Comparison with the Predicate device [21 CFR 807.92(a) (6)]
X5 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:
SonoScape S8 Exp Portable Digital Color Doppler Ultrasound System K152164
#### Intended Use Comparison:
Compared with the predicate device SonoScape S8 Exp (K152164), the Subject Device X5 has the same intended use.
{14}------------------------------------------------
| ID | Comparison<br>Items | Subject Device<br>SonoScape X5 | Predicate Device<br>SonoScape S8 Exp (K152164) |
|----|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended<br>Use | The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology. | The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic. OB/Gyn and Urology. |
#### Table 1 Intended Use Comparison
Note: According to Section D in the "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], issued on: July 28, 2014", the indications for use of the new device fall within the intended use of the predicate device, the two devices have the same intended use.
#### Regulation and Safety Standards Comparison:
Subject device X5 has the same classification as the predicate device. And subject device X5 is designed in compliance with the FDA recognized safety standards, which are the same as the predicate device.
| ID | Comparison<br>Items | Subject Device<br>SonoScape X5 | Predicate Device<br>SonoScape S8 Exp (K152164) | Remark |
|----|------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------|
| 2 | Classification<br>Name | Ultrasonic Pulsed Doppler<br>Imaging System<br>Ultrasonic Pulsed Echo<br>Imaging System<br>Diagnostic Ultrasound<br>Transducer | Ultrasonic Pulsed Doppler<br>Imaging System<br>Ultrasonic Pulsed Echo Imaging<br>System<br>Diagnostic Ultrasound<br>Transducer | Same |
| 3 | Product Code | 90-IYN/90-IYO/90-ITX | 90-IYN/90-IYO/90-ITX | Same |
| 4 | Regulation<br>Number | 892.1550/892.1560/892.1570 | 892.1550/892.1560/892.1570 | Same |
| 5 | Panel | Radiology | Radiology | Same |
| 6 | Class | II | II | Same |
| 7 | Acoustic Track | TRACK 3 | TRACK 3 | Same |
| 8 | Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
Table 2 Regulation and Safety Standards Comparison
510(k) Summary
{15}------------------------------------------------
| ID | Comparison<br>Items | Subject Device<br>SonoScape X5 | Predicate Device<br>SonoScape S8 Exp (K152164) | Remark |
|----|--------------------------------|--------------------------------|------------------------------------------------|--------|
| | EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| | Performance | IEC 60601-2-37 | IEC 60601-2-37 | Same |
| | Biocompatibility | ISO 10993-5,<br>ISO 10993-10 | ISO 10993-5,<br>ISO 10993-10 | Same |
| | Acoustic Output<br>Display | AIUM/NEMA UD3-2004<br>(R2009) | AIUM/NEMA UD3-2004<br>(R2009) | Same |
| | Acoustic Output<br>Measurement | AIUM/NEMA UD2-2004<br>(R2009) | AIUM/NEMA UD2-2004<br>(R2009) | Same |
## Acoustic Output Levels Comparison:
The acoustic output levels of the subject device X5 are below the limits of FDA, which are the same as the predicate device SonoScape S8 Exp (K152164).
| Table 3 Acoustic Output Levels Comparison | | | | | | |
|-------------------------------------------|--|--|--|--|--|--|
|-------------------------------------------|--|--|--|--|--|--|
| ID | Comparison Items | Subject Device<br>SonoScape X5 | Predicate Device<br>SonoScape S8 Exp (K152164) | Remark |
|----|------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------|
| 9 | Acoustic Output | Derated ISPTA: 720mW/cm2<br>maximum.<br>TIS/TIB/TIC: 6.0 maximum,<br>MI: 1.9 maximum,<br>Derated ISPPA: 190W/cm2<br>maximum | Derated ISPTA: 720mW/cm2<br>maximum.<br>TIS/TIB/TIC: 6.0 maximum,<br>MI: 1.9 maximum,<br>Derated ISPPA: 190W/cm2<br>maximum | Same |
# Probes Comparison:
Subject device X5 has the similar probes as the predicate device SonoSca…
