(28 days)
Not Found
No
The description focuses on traditional ultrasound signal processing techniques (Doppler, autocorrelation, DSC) and does not mention AI or ML.
No.
The device is intended for diagnostic imaging, not for treating or preventing diseases.
Yes
The device description states it is "intended for clinical diagnostic imaging applications" and is a "color diagnostic ultrasound system." The Intended Use/Indications for Use section also lists various medical evaluations it is used for by a qualified physician.
No
The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and lists hardware components such as "keyboard control panel, power supply module, color LCD monitor and optional probes." It also describes the function of probes as "electrical-acoustical and acoustical-electrical transducers," indicating a significant hardware component beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SonoScape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound System is an ultrasound imaging system. It uses sound waves to create images of internal organs and structures within the patient's body.
- Intended Use: The intended use clearly states it's for "evaluation of Fetal, Abdominal, Pediatric, Small Organ... etc." This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description: The description details how the system transmits and receives ultrasonic energy from the patient's body to create images. There is no mention of analyzing biological specimens.
Therefore, this device falls under the category of in vivo diagnostic imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SonoScape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound 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 (pediatric and adult), OB/Gyn and Urology.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
This SonoScape X3 Exp/X3/X3 Pro/X1 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 X3 Exp/X3/X3 Pro/X1 Pro/X1 system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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 (pediatric and adult), OB/Gyn and Urology.
Indicated Patient Age Range
Fetal, Pediatric, Neonatal and Adult.
Intended User / Care Setting
qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2017
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: K163427
Trade/Device Name: X3 Exp/X3/X3 Pro/X1 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: November 30, 2016 Received: December 6, 2016
Dear Ms. Wu:
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
1
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. 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,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
Indications for Use (Describe)
The SonoScape X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound 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 (pediatric and adult), OB/Gyn and Urology.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
SonoScape X3 Exp/X3/X3 Pro/X1 Pro/X1 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 | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Fetal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2 | |||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,6 | |||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2 | ||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2 | |
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Intravascular | ||||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2 | ||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2 | ||
| Cardiac | Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2 | ||
| Cerebral vascular | P |
P = previously cleared by FDA; E = added under this appendix N = new indication;
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
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
General
(TRACK 1
| ONLY) | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | P | P | P | P | P | Note 1 | Notes 2 | ||
| Other (Urology) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular(Cardiac) | |||||||||
| Cardiac | Trans-esoph.(Cardiac) | ||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Cerebral vascular |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Other Combined includes: BM; 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 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Note 7: Elastography
Note 5: 4D
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 | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Imaging& | |||||||||
| Other | Fetal | ||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2 | ||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2 | |
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph.(non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2 | |
| Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral 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 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
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 | |||||||||
| (TRACK 1 | |||||||||
| ONLY) | Specific | ||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| (Amplitude) | |||||||||
| Doppler | Other* | ||||||||
| Combined | Other* | ||||||||
| Specify | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Intra-operative Specify | |||||||||
| Intra-operative Neuro | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 2 | |
| Fetal | |||||||||
| Imaging& | |||||||||
| Other | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2 |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Other (Urology) | |||||||||
| Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2 | |
| Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2 | |
| Cardiac | Intravascular(Cardiac) | ||||||||
| Trans-esoph.(Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral 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
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 Power Other* Specific Color Other* (TRACK 1 (Amplitude) Specify (TRACKS 1 & 3) B PWD CWD M Doppler Combined ONLY) Doppler Ophthalmic Ophthalmic Fetal Abdominal Intra-operative Specify Intra-operative Neuro Laparoscopic Pediatric Notes 2 P P P P P Note 1 Small Organ (specify) Neonatal Cephalic P P P P P P Note 1 Notes 2 Adult Cephalic Fetal Trans-rectal Imaging& Trans-vaginal Other Trans-urethral Trans-esoph.(non-Card) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Other (Ob/GYN) Other (Urology) Cardiac Adult Cardiac Pediatric P P P P P P 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
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 | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | P | P | P | P | P | Note 1 | Notes 2,6 | |||
| Neonatal Cephalic | ||||||||||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | P | P | P | P | P | 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 vessel | P | P | P | P | P | Note 1 | Notes 2 | |||
| Cerebral vascular | ||||||||||
| Peripheral | ||||||||||
| Vessel |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; 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
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 | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | ||||||||||
| Imaging& | ||||||||||
| Other | Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular(Cardiac) | ||||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Cardiac | Intra-cardiac | |||||||||
| Other (specify) | ||||||||||
| Peripheral vessel | ||||||||||
| Cerebral vascular | ||||||||||
| Peripheral | ||||||||||
| Vessel |
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
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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 | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| Imaging& | Trans-rectal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Other | Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2 | ||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | P | P | P | P | P | Note 1 | Notes 2 | |||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intravascular(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: BM; B/PWD; B/THI; 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
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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 | ||||||||||
| (TRACK 1 | ||||||||||
| ONLY) | Specific | |||||||||
| (TRACKS 1 & 3) | B | M | PWD | CWD | Color | |||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Other* | |||||||||
| Combined | Other* | |||||||||
| Specify | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative Specify | ||||||||||
| Intra-operative Neuro | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | P | ||||||||
| Imaging& | Trans-rectal | |||||||||
| Other | Trans-vaginal | |||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non-Card) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Ob/GYN) | ||||||||||
| Other (Urology) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular(Cardiac) | |||||||||
| Trans-esoph.(Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (specify) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Cerebral vascular | P |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Other Combined includes: BM; B/PWD; B/THI; 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
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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, |
| Nanshan, Shenzhen 518051, Guangdong, China | |
| Contact Person: | Toki Wu |
| Tel: | +86 755 26722890 |
| Fax: | +86 755 26722850 |
| Email: | ra@sonoscape.net |
| Date Prepared | December 23, 2016 |
2. Device [21 CFR807.92 (a) (2)]
| Trade Name: | X3 Exp/X3/X3 Pro/X1 Pro/X1 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 X5 Digital Color Doppler Ultrasound System
4. Device Description [21 CFR 807.92(a) (4)]
This SonoScape X3 Exp/X3/X3 Pro/X1 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 X3 Exp/X3/X3 Pro/X1 Pro/X1 system utilizes the ultrasound echo characteristics,
13
transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the 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 X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound 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 (pediatric and adult), OB/Gyn and Urology.
6. Comparison with the Predicate device [21 CFR 807.92(a) (6)]
X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is comparable with and substantially equivalent to the predicate device:
SonoScape X5 Digital Color Doppler Ultrasound System K160258
Intended Use Comparison:
Compared with the predicate device SonoScape X5 (K160258), the Subject Device X3
14
Exp/X3/X3 Pro/X1 Pro/X1 has the same intended use.
Technical Characteristics Comparison:
Compared with the predicate device SonoScape X5 (K160258), the Subject Device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same technical characteristics, including Design, Operation Controls, Operation Mode, Display Modes, Measurement Items, Power Supply, Screen Size, Cine Loop, Operating and Storage Condition.
Compared with the predicate device SonoScape X5 (K160258), there are some hardware optimizations made to the Subject Device X3 Exp/X3/X3 Pro/X1, including the modification of the video conversion chip in the display module which makes the display better, additional isolation to the IO docking station and other minor changes or optimizations on the circuit, which will not affect the safety and effectiveness of the Subject Device.
Probes Comparison:
Subject device X3 Exp/X3/X3 Pro/X1 Pro/X1 has the same probes as the predicate device SonoScape X5 (K160258).
| Subject device
SonoScape X5 | Predicate Device
SonoScape X5 (K160258) | Remark |
|--------------------------------|--------------------------------------------|--------|
| 3C-A Curved Array | 3C-A Curved Array | Same |
| C613 Micro-curved Array | C613 Micro-curved Array | |
| 3P-A Phased Array | 3P-A Phased Array | |
| 7P-B Phased Array | 7P-B Phased Array | |
| L741 Linear Array | L741 Linear Array | |
| 6V1 Micro-curved Array | 6V1 Micro-curved Array | |
| EC9-5 Micro-curved Array | EC9-5 Micro-curved Array | |
| PWD2.0 TCD | PWD2.0 TCD | |
Table 1 Probes Comparison
And, compared with predicate device, the subject device (X3 Exp/X3/X3 Pro/X1 Pro/X1) complies with the same regulation and safety standards and has the consistent acoustic output levels. Therefore they can be considered Substantially Equivalent in safety and effectiveness, and no new risk is raised, so the SE is not affected.
15
7. Non-Clinical Tests [21 CFR 807.92(b) (1)]
The X3 Exp/X3/X3 Pro/X1 Digital Color Doppler Ultrasound System has been evaluated for electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility and acoustic output.
Laboratory tests (including Phantom tests) were conducted to verify that the X3 Exp/X3/X3 Pro/X1 Pro/X1 system met all design specifications and the X3 Exp/X3/X3 Pro/X1 Pro/X1 system conformed to applicable medical device standards.
The X3 Exp/X3/X3 Pro/X1 Pro/X1 system has been designed and manufactured to meet the following standards:
IEC 60601-1:2005+A1:2012, Medical Electrical Equipment - Part 1: General
requirements for basic safety and essential performance [08/20/2012], including the US National Differences;
IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests [03/30/2007];
IEC 60601-2-37:2007, Medical Electrical Equipment-Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment [08/09/2007];
ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in vitro cytotoxicity [06/01/2009];
ISO 10993-10:2010, Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization [08/01/2010];
AIUM/NEMA UD 2:2004 (R2009), Acoustic output measurement standard for diagnostic ultrasound equipment [08/21/2009]; and
AIUM/NEMA UD 3:2004 (R2009), Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment [08/13/2010].
8. Clinical Test [21 CFR 807.92(b) (2)]
No clinical testing was required.
9. Substantially Equivalent Conclusions [21 CFR 807.92(b) (3)]
In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, SONOSCAPE MEDICAL CORP. concludes that X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate device with regard to safety and effectiveness.