Who is the manufacturer of S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM?

Sonoscape Company Limited filed the 510(k) submission for S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM (K110510).

What is the FDA product code for S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

K110510 · Sonoscape Company Limited · IYN · May 16, 2011 · Radiology

Device Facts

Record ID	K110510
Device Name	S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Applicant	Sonoscape Company Limited
Product Code	IYN · Radiology
Decision Date	May 16, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Device Story

S20 Digital Color Doppler Ultrasound System is an integrated, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers (phased, micro-curved, and linear arrays) and displays images in B-Mode, M-Mode, Tissue Harmonic Imaging (THI), Color-Flow Doppler, Pulsed Doppler, Power Doppler, and 3D/4D modes. The system features an all-digital architecture with progressive dynamic receive focusing to enhance diagnostic utility. It is intended for use by qualified physicians in clinical settings. The system provides exam-dependent default settings for ease of use, with advanced soft-menu controls for customization. Output is displayed on the system monitor, allowing clinicians to evaluate anatomy and fluid flow, aiding in diagnostic decision-making and patient management.

Clinical Evidence

Bench testing only. The device was evaluated for design specifications, acoustic output (NEMA UD 2:2004, NEMA UD 3:2004), thermal/mechanical/electrical safety (IEC 60601-1, IEC 60601-2-37), and biocompatibility (ISO 10993-5, ISO 10993-10). No clinical data was required for this 510(k) clearance.

Technological Characteristics

Digital architecture with progressive dynamic receive focusing. Supports B, M, PWD, CWD, Color Doppler, Power Doppler, and 3D/4D modes. Transducers: Phased, Micro-curved, and Linear arrays (2.0-12.0 MHz). Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, and ISO 10993-10. Software-controlled system.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal/adult cephalic, trans-rectal, trans-vaginal, peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), OB/GYN, and urology applications. Prescription use only.

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 Diagnostic Ultrasound System and Transducers (K092922)

Related Devices

K112602 — S6 DIAGNOSTIC ULTRASOUND SYSTEM · Sonoscape Company Limited · Nov 7, 2011
K130119 — PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · Apr 12, 2013
K172993 — P20 Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Dec 5, 2017
K131088 — PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM · Sonoscape Company Limited · May 24, 2013
K132527 — DIGITAL COLOR DOPPLER ULTASOUND SYSTEM · Sonoscape Company Limited · Nov 14, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ SonoScape Company LTD S20 Digital Color Doppier Ultrasound System # Tab 21 PREMARKET NOTIFICATION 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is : #### Manufacturer: SonoScape Company Limited Address: 4/F., Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051, P.R.China Tel: (86) 755-26722890 Fax: (86) 755-26722850 Contact Person: Zhiqiang Chen Date Prepared: Feb 12, 2011 Name of the device: * Trade/Proprietary Name: S20 Digital Color Doppler Ultrasound System * Common Name: Diagnostic Ultrasound System and Transducers * Classification: Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX) #### Legally Marketed Predicate Device: Premarket Notification 510(k) Summary {1}------------------------------------------------ SonoScape S8 Diagnostic Ultrasound System and Transducers - K092922 #### Device Description: The SonoScape S20 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode,TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D. #### Intended 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology. {2}------------------------------------------------ ### Probe Information: | No. | Probe | Type | Frequency Range | Intended Use | |-----|-------|--------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------| | 1 | 2P1 | Phased Array | 2.0-4.0 MHz | Abdominal Neonatal Cephalic Adult Cephalic Cardiac Adult Cardiac Pediatric | | 2 | 5P1 | Phased Array | 3.0-7.0 MHz | Pediatric Neonatal Cephalic Cardiac Pediatric | | 3 | 6V1 | Micro-curved Array | 4.0-8.0 MHz | Trans-rectal Trans-vaginal | | 4 | 6V3 | Micro-curved Array | 5.0-9.0 MHz | Trans-rectal Trans-vaginal | | 5 | EC9-5 | Micro-curved Array | 5.0-9.0 MHz | Trans-rectal Trans-vaginal | | 6 | C611 | Micro-curved Array | 4.0-8.0 MHz | Abdominal Pediatric Neonatal Cephalic Cardiac Pediatric | | 7 | C344 | Curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN | | 8 | C362 | Curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN | | 9 | VC6-2 | Curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN | | 10 | L741 | Linear Array | 5.0-10.0 MHz | Small Organ (breast, thyroid, testes ) Musculo-skeletal (Conventional) Peripheral vessel | | 11 | L742 | Linear Array | 5.0-12.0 MHz | Small Organ (breast, thyroid, testes ) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Peripheral vessel | | 12 | L743 | Linear Array | 5.0-10.0 MHz | Small Organ (breast, thyroid, testes ) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Peripheral vessel | Tab 21.1 Probe information ### Safety Considerations: The S20 Diagnostic Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems Premarket Notification 510(k) Summary 21-3 {3}------------------------------------------------ SonoScape Company LTD and Transducers" issued September 9, 2008. The acoustic output is measured and calculated per NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10. #### Testing: Laboratory testing was conducted to verify that the S20 Digital Color Doppler Ultrasound System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment". | Standards No. | Standards Title | Version | Date | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------| | IEC 60601-1 | IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. | 1988 | 10/31/2005 | | IEC 60601-1-2 | IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. | 2007 | 07/31/2008 | | IEC 60601-2-37 | IEC 60601-2-37 (2004) (2005) Amendment 2, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. | 2007 | 09/08/2009 | Tab 21.2 Applicable Safety Standards Premarket Notification 510(k) Summary {4}------------------------------------------------ | NEMA UD 2 | NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3. | 2004 | 09/08/2009 | |-------------|--------------------------------------------------------------------------------------------------------------------------------------|------|------------| | ISO 10993-5 | ISO 10993-5:1999, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. | 2009 | 09/12/2007 | | 10993-10 | ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity. | 2002 | 09/12/2007 | ## Conclusion: The conclusions drawn from testing of the S20 Diagnostic Ultrasound System with added transducer demonstrate that the device is as safe and effective as the legally marketed predicate devices. Premarket Notification 510(k) Summary 21-5 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the image of an eagle. The eagle is stylized with three curved lines representing its body, wings, and head. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 SonoScape Company Limited % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai, 200237 CHINA MAY 16 2011 Re: K110510 Trade/Device Name: S20 Digital Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: February 18, 2011 Received: February 22, 2011 Dear Ms. Hong: 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 S20 Digital Doppler Ultrasound System, as described in your premarket notification: Transducer Model Number 2P1 Phased Array 5P1 Phased Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array C362 Curved Array C344 Curved Array VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear Array {6}------------------------------------------------ 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/CDRH0ffices/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 Shahram Vaezy at (301) 796-6242. Sincerely Yours, Michael D. O'Keeffe Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ ## 4.4 Tab 3 Indications For Use 510(k) Number: Device Name: S20 Digital Doppler Ultrasound System Indications for Use: The SonoScape S20 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, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and aduit), OB/Gyn and Urology. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Maitha D. Juma (Division Sign Off) (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number K116510 Indications For Use {8}------------------------------------------------ #### System: Sonoscape S20 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 | | | | | | | Other* | | |------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--|----------|-------------| | General (TRACK 1 ONLY) | Specific (TRACKS 1 & 3) | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | | Combined | Specify | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal Imaging& Other | Fetal | N | N | N | | N | N | | Note 1 | Notes 2,4,5 | | | Abdominal | N | N | N | | N | N | | Note 1 | Notes 2,4,5 | | | Intra-operative Specify | | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | N | N | N | | N | N | | Note 1 | Notes 2,4 | | | Small Organ (specify) | N | N | N | | N | N | | Note 1 | Notes 2,4,6 | | | Neonatal Cephalic | N | N | N | N | N | N | | Note 1 | Notes 2,3,4 | | | Adult Cephalic | N | N | N | N | N | N | | Note 1 | Notes 2,3,4 | | | Trans-rectal | N | N | N | | N | N | | Note 1 | Notes 2,4 | | | Trans-vaginal | N | N | N | | N | N | | Note 1 | Notes 2,4 | | | Trans-urethral | | | | | | | | | | | | Trans-esoph.(non-Card) | | | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | | N | N | | Note 1 | Notes 2,4 | | | Musculo-skeletal (Superficial) | N | N | N | | N | N | | Note 1 | Notes 2,4 | | | Intravascular | | | | | | | | | | | | Other (Ob/GYN) | N | N | N | | N | N | | Note 1 | Notes 2,4,5 | | Cardiac | Cardiac Adult | N | N | N | N | N | N | | Note 1 | Notes 2,3,4 | | | Cardiac Pediatric | N | N | N | N | N | N | | Note 1 | Notes 2,3,4 | | | Intravascular(Cardiac) | | | | | | | | | | | | Trans-esoph.(Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Other (specify) | | | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | | N | N | | Note 1 | Notes 2,4 | | | Other (specify) | | | | | | | | | | N = new indication; E = added under this appendix P = previously cleared by FDA; 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 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Note 5: 4I) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Indications For Use Mhnd D. O'Khm (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety K110510 510K {9}------------------------------------------------ Transducer: 2P1 Phase 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 | N | N | N | | N | N | Note 1 | Notes 2,4 | | | Intra-operative Specify | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph.(non-Card) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | Other (Ob/GYN) | | | | | | | | | | Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | 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: Other Combined includes: B/M; B/PWD; B/TH; M/Color M ; B/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 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Indications For Use Michael O'Kee (Division Sign-Off) Division o Office of In Vitro 510K K116510 {10}------------------------------------------------ Transducer: 5P1 Phase 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 | Specific | | | | | Color | Power | Other* | Other* | | (TRACK 1 | (TRACKS 1 & 3) | B | M | PWD | CWD | Doppler | (Amplitude) | Combined | Specify | | ONLY) | | | | | | | Doppler | | | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal | Fetal | | | | | | | | | | Imaging& | | | | | | | | | | | Other | Abdominal | | | | | | | | | | | Intra-operative Specify | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 | | | Small Organ (specify) | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card) | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | (Conventional) | | | | | | | | | | | Musculo-skeletal | | | | | | | | | | | (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | Other (Ob/GYN) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | Intravascular(Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (specify) | | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | | Vessel | Other (specify) | | | | | | | | | 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 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Note 5: 4D Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Indications For Use (Division Sian-Off Division of Radiological Devices Office of In 510K K//65/0 {11}------------------------------------------------ #### 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 Imaging& Other | Fetal | | | | | | | | | | | Abdominal | | | | | | | | | | | Intra-operative Specify | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2,4 | | | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2.4 | | | Trans-urethral | | | | | | | | | | | Trans-esoph.(non-Card) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | 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; E = added under this appendix P = previously cleared by FDA; 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 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Note 5: 4D Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Indications For Use --- (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagu 510K K110510 {12}------------------------------------------------ Transducer: 6V3 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 | | | | | | | | Other* | | |------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|----------|-----------|--------|--| | General (TRACK 1 ONLY) | Specific (TRACKS 1 & 3) | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Combined | Specify | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | | Fetal Imaging& Other | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intra-operative Specify | | | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Trans-rectal | N | N | N | N | N | N | Note 1 | Notes 2,4 | | | | | Trans-vaginal | N | N | N | N | N | N | Note 1 | Notes 2.4 | | | | | Trans-urethral | | | | | | | | | | | | | Trans-esoph. (non-Card) | | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | 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; 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 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR Note 5: 4D Over-The-Counter Use (21 CFR 807 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Indications For Use *(Division Sign-Off)* Division of Radiological Devic Office of In e Evaluation and Safety 510K K110510 {13}------------------------------------------------ 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 Imaging& Other | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intra-operative Specify | | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2,4 | | | | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2,4 | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph.(non-Card) | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | Intravascular | | | | | | | | | | | | 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 | | | | | | | | | | | N = new indication; P = previously cleared by FDA; 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 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Note 5: 4D Over-The-Counter Use (21 CFR 807 Subpart C) 3-7 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 510K Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Indications For Use Nerd D. Oth Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety {14}------------------------------------------------ Transducer: C611 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 | | | | | | Other* | | |------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|----------|-------------|--| | General (TRACK 1 ONLY) | Specific (TRACKS 1 & 3) | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Combined | Specify | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal Imaging& Other | Fetal | | | | | | | | | | | | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 | | | | Intra-operative Specify | | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph.(non-Card) | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Other (Ob/GYN) | | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 | | | | 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: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWI) 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 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Note 5: 4D Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Indications For Use ![](./file_0.png) (Division Sign-Off) Division of Radiological Devices ce Evaluation and Safety Office of In Vitro K110510 510K {15}------------------------------------------------ Transducer: C362 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 | | | | | | Other* | | |------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|----------|-----------|--| | General (TRACK 1 ONLY) | Specific (TRACKS 1 & 3) | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Combined | Specify | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal Imaging & Other | Fetal | N | N | N | | N | N | Note 1 | Notes 2,4 | | | | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 | | | | Intra-operative Specify | | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Card) | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2.4 | | | Cardiac | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | Intravascular(Cardiac) | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Other (specify) | | | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | | | Vessel | Other (specify) | | | | | | | | | | N = new indication; E = added under this appendix P = previously cleared by FDA; Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; 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 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Note 5: 4D Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD) Indications For Use *(Division Sign-Off)* Division of Radiologi uation and Safety 510 {16}------------------------------------------------ Transducer: C344 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 | N | N | N | N | N | N | Note 1 | Notes 2, 4 | | | | Abdominal | N | N | N | N | N | N | Note 1 | Notes 2, 4 | | | | Intra-operative Specify | | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph.(non-Card) | | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | Notes 2, 4 | | | Cardiac | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | Intravascular(Cardiac) | | | | | | | | | | | | Trans-esoph.(Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Other (specify) | | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | | Other (specify) | | | | | | | | | | 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 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Note 5: 4D Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Indications For Use (Division Sign Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K K110510 {17}------------------------------------------------ #### Sonoscape Company LTD ### Diagnostic Ultrasound Indications for Use Form Transducer: VC6-2 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 | N | N | N | N | N | N | Note 1 | Notes 2,4,5 | | | Abdominal | N | N | N | N | N | N | Note 1 | Notes 2,4,5 | | | Intra-operative Specify | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph.(non-Card) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | Other (Ob/GYN) | N | N | N | N | N | N…