(37 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.
The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are essential.
The provided document is a 510(k) summary for the SonoTouch Series Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than performing new clinical effectiveness studies with specific acceptance criteria and detailed performance reporting. Therefore, much of the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, and sample sizes is not present in this document.
The document primarily states that the device is "substantially equivalent" to predicate devices (GE LOGIQ i, LOGIQ e, Vivid e Diagnostic Ultrasound (K102256)) based on its intended use, operating modes, grayscale imaging, acoustic output levels, and adherence to safety standards.
Here's a breakdown of what can be extracted and what is not available:
1. Table of acceptance criteria and the reported device performance
No specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document. The basis for acceptance is "substantial equivalence" to the predicate device.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Intended Use | Comparable to predicate device. | Device intended for Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal. |
| Operating Modes | Comparable to predicate device. | B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes. |
| Imaging Quality | Comparable grayscale to predicate device. | "The systems have the same gray-scale." |
| Acoustic Output | Below applicable FDA limits. | "The systems have acoustic output levels below the applicable FDA limits." |
| Safety Standards | Adherence to specific product safety standards. | Designed to meet NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1. |
2. Sample size used for the test set and the data provenance
Not applicable for a 510(k) substantial equivalence submission, as it typically does not involve new clinical effectiveness studies with test sets in this manner. The comparison is based on the technical and functional characteristics of the device relative to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware ultrasound system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is mentioned. The comparison is against a predicate device's established performance and safety.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of the Study/Basis for Acceptance:
The "study" in this context is a technical and regulatory comparison against a legally marketed predicate device (GE LOGIQ i, LOGIQ e, Vivid e Diagnostic Ultrasound, K102256).
- Basis for Acceptance: The device is considered "substantially equivalent" in safety and effectiveness to the predicate devices. This means that it has the same intended use, fundamental technological characteristics, and safety and performance characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.
- Proof: The documentation submitted (which is summarized here) asserts that:
- The SonoTouch Series has the same intended uses as the predicate devices (listed in detail across multiple pages for various transducers).
- It utilizes comparable operating modes (B-Mode, M-Mode, Doppler modes, etc.).
- It offers "the same gray-scale" imaging capabilities.
- Its acoustic output levels are below FDA limits.
- It adheres to relevant product safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).
This 510(k) summary does not contain information about clinical studies with specific performance metrics or statistical analyses typically found in PMAs or some de novo classifications. The acceptance is based on the regulatory pathway of substantial equivalence.
{0}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound System
AUG 2 2012
PREMARKET NOTIFICATION [510(k)] Summary
This Summary of Safety and Effectiveness is prepared in accordance with 21 CFR Part 807.92(c).
1. Company Name:
Chison Medical Imaging Co., Ltd. Submitter: No.8, Xiang Nan Road, Shuo Fang, New District, Wuxi, China 214142
| Contact: | Ms. Ruoli Mo |
|---|---|
| Tel: +86-510-85311707, 85310593 | Fax: +86-510-8531072 |
Date Prepared:May 22,2012
- Device Name: SonoTouch Series Diagnostic Ultrasound System 2.
Common/Usual Name: Diagnostic Ultrasound System with Accessories
Classification: Regulatory Class: II Review Category: Tier II
| Classification Name | 21 CFR Section | Product Code |
|---|---|---|
| Ultrasonic pulsed doppler imaging system | 892.1550 | 90-IYN |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90-IYO |
| Diagnostic ultrasonic transducer | 892.1570 | 90-ITX |
2. Marketed Device:
K102256, GE LOGIQ e Uitrasound System
3. Device Description:
The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are 这一次的一次的" រ និងប្រជាជា បានបាត A .. a " admal) Uleman
ت محمدر واقع آباد الموقع ಿ Attachment I
{1}------------------------------------------------
essential.
The SonoTouch Series Models, have been designed to meet the following product safety standards: NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1.
4. Indications for Use:
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vasculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.
Comparison to Predicate Device:
The SonoTouch Series Models is of comparable type and substantially equivalent to the GE LOGIQ i, LOGIQ e,Vivid e Diagnostic Ultrasound(K102256) . All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body, and have the same intended uses and basic operating modes as the predicate device. All systems allow for specialized measurements of structures and flow, and calculations.
5. Conclusion:
The SonoTouch Series Models is substantially equivalent in safety and effectiveness to the predicate systems. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. The systems have the same gray-scale. The systems have acoustic output levels below the applicable FDA limits. The systems are designed to applicable electrical and physical safety standards.
End of 510(k) Summary.
1 Attachment I
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 2 2012
CHISON Medical Imaging Co., Ltd. % Mr. Michael S. Ogunleye Third Party Program Manager/Lead Medical Auditor TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K121867
Trade/Device Name: SonoTouch Series Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 25, 2012 Received: July 25, 2012
Dear Mr. Ogunleve:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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), 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.
This determination of substantial equivalence applies to the following transducers intended for use with the SonoTouch Series Diagnostic Ultrasound Systems, as described in your premarket notification:
Transducer Model Number
C3. Convex Array MC3. Micro-convex Array V6, Micro-convex Array L7M, Linear Array L7S, Linear Array
R7, Linear Array L7L, Linear Array P3, Phased Array MC5V, Convex Array MC6. Convex Array
{3}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours,
Michael D. O'Hern for
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
{4}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems
Diagnostic Ultrasound Indications For Use
1.3 Indications for Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.
(Division Sign-Off)
Division of Radiological Devices
12/2/2020 DIVD**
AND/OR Prescription Use V Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ence of CDRH, Office of Device Evaluation (ODE) 11 0
Indications For Use
-2 315 - 1
{5}------------------------------------------------
Diagnostic Ultrasound Indications For Use
System: SonoTouch Series Diagnostic Ultrasound Systems
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 | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | Abdominal | N | N | N | N | N | Note 1 | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | |||
| Small Organ (Specify) | N | N | N | N | N | Note 1 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | |||
| Trans-vaginal | N | N | N | N | N | Note 1 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | Note 1 | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1 | |||
| Intravascular | |||||||||
| Other (Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | ||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments:
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
| 510k | K121889 |
|---|---|
| ------ | --------- |
| Section 1.3 | Indications For Use | Page 2 of 12 |
|---|---|---|
| ------------- | --------------------- | -------------- |
{6}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems System: Transducer: C3, Convex Array
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 | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N | Note 1 | ||
| Abdominal | N | N | N | N | N | Note 1 | |||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | Note 1 | |||
| Small Organ[1] (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix : Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments:
Small Organ: Thyroid, testes and breast
Additional Comments:
| Prescription Use(Part 21 CFR 801 Subpart D) | √ | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|---|
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Division of Radiological Devices |
510k K121867
| Section 1.3 | Indications For Use | Page 3 of 12 |
|---|---|---|
| ------------- | --------------------- | -------------- |
{7}------------------------------------------------
System: SonoTouch Series Diagnostic Ultrasound Systems Transducer: MC3, Micro-convex Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | |||||||
| Abdominal | N | N | N | N | N | Note 1 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ(1) (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Urology) | ||||||||
| Other (Ob/GYN) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | |
| Cardiac Pediatric | N | N | N | N | N | Note 1 | ||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) |
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments:
Small Organ: Thyroid, testes and breast
Additional Comments:
| Prescription Use(Part 21 CFR 801 Subpart D) | ✓ |
|---|---|
| AND/OR | |
| Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
of CDRH, Office of Device Evaluation (ODE)
Division of Radiological Devices
| Section 1.3 | K821867 |
|---|---|
| Indications For Use |
Page 4 of 12
{8}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems System: Transducer: V6, Micro-convex Array
| Clinical Application | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N | Note 1 | ||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(1) (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | |||
| Trans-vaginal | N | N | N | N | N | Note 1 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Urology) | N | N | N | N | N | Note 1 | |||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | |||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
P = previously cleared by FDA; N = new indication; E = added under this appendix
Other (Specify)
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments: Small Organ: Thyroid, testes and breast
Additional Comments:
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
510k Section 1.3 K121867
Indications For Use
Page 5 of 12
{9}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems
System: SonoTouch Series Diagnostic Ultrasound Systems Transducer: L7M, Linear Array
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 | ColorDoppler | Power(Amplitude)Doppler | Other*Combined |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | Fetal | |||||||
| Other | Abdominal | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1 | ||
| Small Organ(1) (Specify) | N | N | N | N | N | Note 1 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | Note 1 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1 | ||
| Intravascular | t | |||||||
| Other (Urology) | ||||||||
| Other (Ob/GYN) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel Peripheral vessel | N | N | N | N | N | Note 1 | ||
| Other (Specify) | ||||||||
| P = previously cleared by FDA;N = new indication; | E = added under this appendix |
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments:
Small Organ: Thyroid, testes and breast Additional Comments:
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
510k K121867
Indications For Use
(1)
{10}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems
Chison Medical Imaging Co., Ltd.
SonoTouch Series Diagnostic Ultrasound Systems System: L7S, Linear Array Transducer:
Mode of Operation Clinical Application General Specific B M PWD CWD Color Power Other* (Track 1 Only) (Tracks 1 & 3) Doppler (Amplitude) Combined Doppler Ophthalmic Ophthalmic Fetal Imaging & Fetal Other Abdominal Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric N N N N . N Note 1 Small Organ(1) (Specify) N N N N N Note 1 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) N N N N N Note 1 N N N N Note-1 Musculo-skeletal (Superficial) N Intravascular Other (Urology) : Other (Ob/GYN) Cardiac Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Vessel Peripheral vessel N N N N N Note 1 Other (Specify) P = previously cleared by FDA; E = added under this appendix N = new indication;
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments: Small Organ: Thyroid, testes and breast
Additional Comments:
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
510k
Section 1.3 Indications For Use Page 7 of 12
{11}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems System:
Transducer: R7, Linear Array
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 | CWDNote 3 | ColorDoppler | Power(Amplitude)Doppler | Other*Combined |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ(1) (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | Note 1 | ||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Urology) | N | N | N | N | N | Note 1 | ||
| Other (Ob/GYN) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) | ||||||||
| N = new indication; P = previously cleared by FDA; E = added under this appendix |
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments:
| Prescription Use | ✓ (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | (21 CFR 801 Subpart C) |
|---|---|---|---|---|
| ------------------ | ------------------------------------------ | -------- | ---------------------- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
| 510k | K121867 |
|---|---|
| ------ | --------- |
| Section 1.3 | Indications For Use | Page 8 of 12 |
|---|---|---|
| ------------- | --------------------- | -------------- |
{12}------------------------------------------------
System: SonoTouch Series Diagnostic Ultrasound Systems L7L, Linear Array Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the buman body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1 | ||
| Small Organ1 (Specify) | N | N | N | N | N | Note 1 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | Note 1 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | Note 1 | ||
| Intravascular | ||||||||
| Other (Urology) | ||||||||
| Other (Ob/GYN) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | |
| Other (Specify) |
P = previously cleared by FDA; N = new indication;
E = added under this appendix
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments:
| Prescription Use | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Radiological Devices
| 510k | K121887 | |
|---|---|---|
| Section 1.3 | Indications For Use | Page 9 of 12 |
{13}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems
Chison Medical Imaging Co., Ltd.
SonoTouch Series Diagnostic Ultrasound Systems System: Transducer: P3, Phased Array
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 | ColorDoppler | Power(Amplitude)Doppler | Other*Combined |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ[1] (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Urology) | ||||||||
| Other (Ob/GYN) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 |
| Cardiac Pediatric | N | N | N | N | N | N | Note 1 | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) | ||||||||
| N = new indication;P = previously cleared by FDA; | E = added under this appendix |
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler+PWD, B+Power Doppler+PWD, B+Power Doppler+PWD
Comments:
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Radiological Devices
510k K121867 QIVD
| Section 1.3 | Indications For Use | Page 10 of 12 |
|---|---|---|
| ------------- | --------------------- | --------------- |
{14}------------------------------------------------
:
System: . SonoTouch Series Diagnostic Ultrasound Systems Transducer: MC5V, Convex Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | ||
| General(Track 1 Only) | Specific(Tracks 1 & 3) | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Other | Abdominal | N | N | N | N | N | Note 1 | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | Note 1 | ||
| Small Organ[1] (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Urology) | ||||||||
| Other (Ob/GYN) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | N | N | N | N | N | Note 1 | ||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication;
E = added under this appendix
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler, B+Color Doppler+PWD, B+Power Doppler+PWD Comments:
Small Organ: Thyroid, testes and breast Additional Comments:
| Prescription Use √(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use _(21 CFR 801 Subpart C) |
|---|---|---|
| --------------------------------------------------- | -------- | -------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
510k K121867
| Section 1.3 | Indications For Use | Page 11 of 12 |
|---|---|---|
| ------------- | --------------------- | --------------- |
{15}------------------------------------------------
SonoTouch Series Diagnostic Ultrasound Systems System: MC6, Convex Array Transducer:
Mode of Operation Clinical Application CWD Power Other* PWD Color Specific B M General Doppler (Amplitude) Combined (Tracks 1 & 3) (Track 1 Only) Doppler Ophthalmic Ophthalmic Fetal Fetal Imaging & N N Note 1 N N N Other Abdominal Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Note 1 N N N N N Pediatric Small Organ (Specify) N N N N N Note 1 Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Other (Urology) Other (Ob/GYN) Cardiac Adult Cardiac Note 1 N N N Z Cardiac Pediatric N Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) N N N N Note 1 Peripheral Vessel Peripheral vessel N Other (Specify) P = previously cleared by FDA; E = added under this appendix N = new indication;
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Note 1: B+M, B+PWD, B+Color Doppler, B+Power Doppler PWD, B+Power Doppler+PWD, B+Power Doppler+PWD Comments:
Small Organ: Thyroid, testes and breast Additional Comments:
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Radiological Devices
510k K121867
Indications For Use
§ 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.