Who is the manufacturer of S8 DIAGNOSTIC ULTRASOUND SYSTEM?

Sonoscape Company Limited filed the 510(k) submission for S8 DIAGNOSTIC ULTRASOUND SYSTEM (K112451).

What is the FDA product code for S8 DIAGNOSTIC 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 S8 DIAGNOSTIC ULTRASOUND SYSTEM?

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

Who can help prepare an FDA 510(k) submission like S8 DIAGNOSTIC 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.

S8 DIAGNOSTIC ULTRASOUND SYSTEM

Q: What are the predicate devices for S8 DIAGNOSTIC ULTRASOUND SYSTEM?

SonoScape S8 Diagnostic Ultrasound System (K092922).

K112451 · Sonoscape Company Limited · IYN · Sep 16, 2011 · Radiology

Device Facts

Record ID	K112451
Device Name	S8 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant	Sonoscape Company Limited
Product Code	IYN · Radiology
Decision Date	Sep 16, 2011
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.

Device Story

S8 Diagnostic Ultrasound System is an integrated, preprogrammed color ultrasound imaging system. It processes ultrasonic signals to produce high-resolution diagnostic images. The system is operated by qualified physicians in clinical settings. The device was modified from an AC-only power supply to a system utilizing an internal Li-ion battery pack with an external AC adapter, allowing operation without mains power. The system includes a control panel with added LED indicators. The device provides diagnostic imaging and fluid flow analysis across various clinical applications, including abdominal, cardiac, and OB/GYN. Healthcare providers use the visual output to evaluate anatomy and pathology, supporting clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. The device was tested for compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5, and ISO 10993-10. Acoustic output was measured per NEMA UD 2:2004 and NEMA UD 3:2004. No clinical data was required or provided.

Technological Characteristics

Diagnostic ultrasound system using pulsed echo and pulsed Doppler imaging. Materials conform to ISO 10993-5/10. Power supply: internal Li-ion battery pack with external AC adapter (100-240V AC). Connectivity: standard ultrasound transducer interfaces. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Imaging modes include B, M, PWD, CWD, Color Doppler, Power Doppler, 3D/4D, and Tissue Harmonic Imaging.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring evaluation of abdomen, cardiac, small organs (breast, testes, thyroid), peripheral vascular, musculoskeletal (conventional/superficial), pediatric, fetal, cephalic, OB/GYN, and urology applications.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

SonoScape S8 Diagnostic Ultrasound System (K092922)

Related Devices

K063580 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM · Medison Co., Ltd. · Dec 14, 2006
K170277 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 23, 2017
K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 18, 2017
K092922 — SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER · Sonoscape Company Limited · Mar 12, 2010
K061682 — GE VOLUSON E8 ULTRASOUND SYSTEM · General Electric Co. · Jul 12, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ K112451 S8 Diagnostic Ultrasound System # Tab 19 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: Chen Zhiqiang Date Prepared: July 12, 2011 ## Name of the device: - * Trade/Proprietary Name: - S8 Diagnostic 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: K092922, SonoScape S8 Diagnostic Ultrasound System Premarket Notification 510(k) Summary {1}------------------------------------------------ ## Device Description: The SonoScape S8 Ultrasound System, previously cleared under K092922, is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The only modifications that were made are: The original S8 Diagnostic Ultrasound System, was previously cleared in K092922 dated March 12, 2009, uses an internal SMPS as its power supply system. And the proposed device was redesigned, changing from AC to battery power, i.e. the internal Li-ion Battery Pack (with an external AC adapter). Such a change is accompanied by labeling changes, but not including new indication for use (See Tab 3). Table 21.1 lists the differences between the two power supply systems. | Model Item | S8 K092922 (with SMPS) | S8 TBD (with Battery Pack and AC Adapter) | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Power supply | No battery pack is provided; The SMPS forms the power supply system. | An internal battery pack is provided; The power supply system consists of the AC adapter and DC converter and a Li-ion Battery Pack. | | Working Principle of the Power Supply | The SMPS converts the 220V or 110V mains voltage to the DC voltages (+12V, -12V, +5V, +3.3V, +5VSB) required by all the electronic parts in the S8 Series System. | The AC adapter converts the mains voltage (100-240V AC) to a DC voltage of approximately +17.5V. Supplied with this DC voltage, the DC converter charges the battery and also converts the DC voltage to the lower voltages (+12V, -12V, +5V, +3.3V, +5VSB) required by all the electronic parts in the S8 system, and at the same time controls the LED indicators on the control panel/keyboard. | # Table 21.1 Comparison of the Switching Mode Power Supply (SMPS) System and the Battery Pack Power Supply System {2}------------------------------------------------ | SonoScape Company LTD | S8 Diagnostic Ultrasound System | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Model Item | S8 K092922 (with SMPS) | S8 TBD (with Battery Pack and AC Adapter) | | Control Panel/ Keyboard | / | Compared to control panel of the original certified product, three LEDs have been added at the bottom right corner of the control panel. | | Remarks | 1)Since the original S8 System does not have internal battery, it requires the mains supply to operate. When no mains supply is provided, the system can not be turned on. 2)With the Li-ion Battery Pack, the S8 System can operate even when no mains supply is available. | | # Intended Use: The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology. This is the same intended use as previously cleared for the SonoScape S8 Diagnostic Ultrasound System, K092922. # 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 | # Tab 21.2 Probe information Premarket Notification 510(k) Summary {3}------------------------------------------------ SonoScape Company LTD S8 Diagnostic Ultrasound System | No. | Probe | Type | Frequency Range | Intended Use | |-----|-------|--------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------| | 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 | #### Safety Considerations: The S8 Diagnostic Ultrasound System 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 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 S8 Diagnostic Ultrasound System met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to {4}------------------------------------------------ #### SonoScape Company LTD 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 | | 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 | # Tab 21.3 Applicable Safety Standards # Conclusion: The conclusions drawn from testing of the S8 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo with a stylized bird-like symbol on the right and a circular arrangement of text on the left. The text appears to be "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird-like symbol is composed of curved lines, giving it a sense of motion or flight. 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 SEP 16 2011 Re: K112451 Trade/Device Name: S8 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, 1YO, and ITX Dated: August 24. 2011 Received: August 25. 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 S8 Diagnostic Ultrasound System, as described in your premarket notification: Transducer Model Number 2P1 Phase Arrav 5P1 Phase Array 6V ! Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Arrav 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 (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. This letter will allow you to begin marketing vour 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/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 Shahram Vaezy, Ph.D. at (301) 796-6242. Sincerely Yours. Mary S Postiff 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}------------------------------------------------ # Tab 3 Indications For Use 510(k) Number: Device Name: S8 Diagnostic Ultrasound System - Indications for Use: The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, 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) May S. Patel (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number K112451 {8}------------------------------------------------ #### System: Sonoscape S8 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 2,4,5 | | | Abdominal | P | P | P | | P | P | Note 1 | Notes 2,4,5 | | | Intra-operative Specify | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | P | P | P | | P | P | Note 1 | Notes 2,4 | | | Small Organ (specify) | P | P | P | | P | P | Note 1 | Notes 2,4,6 | | | Neonatal Cephalic | P | P | P | P | P | P | Note 1 | Notes 24 | | | Adult Cephalic | P | P | P | P | P | P | Note 1 | Notes 2, 4 | | | 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 2,4 | | | Musculo-skeletal (Superficial) | P | P | P | | P | P | Note 1 | Notes 2,4 | | | Intravascular | | | | | | | | | | | Other (Ob/GYN) | P | P | P | | P | P | Note 1 | Notes 2,4,5 | | Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3 | | | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | | | Intravascular(Cardiac) | | | | | | | | | | | Trans-esoph.(Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (specify) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | P | P | Note 1 | Notes 2 | | | Other (specify) | | | | | | | | | N = new indication; Prescription Use P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 2: Tissue Harmonic Imaging. (Part 21 CFR 801 Subpart D) Note 5: 4D Note 3: TDI Note 6: Small Organ: breast, thyroid, testes X Note 4: 3D 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) 510 Mary S. Patel --- (Division Sign Off) Indications For Use Division Sign Division of Pradiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety K112451 3-2 {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& | Fetal | | | | | | | | | | | | Other | 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 | | | | | 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) | | | | | | | | | | | | Cardiac | Cardiac Adult | P | P | P | P | P | P | Note 1 | Notes 2,3 | | | | | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | | | | | 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: B/M: B/PWD: B/THI; M/Color M : B/Color Doppler; B/Color Doppler;PWD; B/Power Doppler/PWD Note 2: Tissue Harmonic Imaging. 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) Man S. Patel sion Sio Division of Radiological D Office of In 610K K112451 3-3 Indications For Use {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 (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 | 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) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | | | Intravascular(Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (specify) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | Other (specify) | | | | | | | | | **P = previously cleared by E** 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. 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 Mary S. Patel 3-4 Division of Radiological Di Office of In Vitro Diagnostic De 510K {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 | Fetal | | | | | | | | | | | | Imaging& Other | Abdominal | | | | | | | | | | | | | Intra-operative Specify | | | | | | | | | | | | | Intra-operative Neuro | | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | 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) | | | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | | Intravascular(Cardiac) | | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | N = new indication; | Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD | | | P = previously cleared by FDA; | | | | E = added under this appendix | | | | | | Note 2: Tissue Harmonic Imaging. | | | | | | | | | | | | Note 3: TDI | Note 4: 3D | | | Note 5: 4D | | | | | | | | | | Note 6: Small Organ: breast, thyroid, testes | | | | | | | | | | | | Prescription Use | X | | | AND/OR | | | | Over The Counter Use | | | | (Part 21 CFR 801 Subpart D) (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 Maus. Potel 3-5 (Division Sign-Off) Division of Radiologica Office of In and Sefety 510K K1124/S1 {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 | 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) | | | | | | | | | | 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 | | | | | | | | | | P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 2: Tissue Harmonic Imaging. 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 Mays Patel (Division Sign-Off) Division of Radiological Devices Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety I 510K K12451 3-6 {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 | | | | | Other* | | |----------------------------------------------------------------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|---------------------------------|--------------------|-------------------| | 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 | 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) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular(Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (specify) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | Other (specify) | | | | | | | | | | P = previously cleared by FDA; E = added under this appendix 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 Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD Note 5: 4D Note 2: Tissue Harmonic Imaging. 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) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) ・ Indications For Use Mary S Patel `3-7` (Division Sign-Off) Office of In and Safety 510K {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 | 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) | | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | P | P | P | P | P | P | Note 1 | Notes 2,3 | | | | 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; WD; B/Power Doppler/PWD Note 2: Tissue Harmonic Imaging. Note 3: TDI Note 4: 3D Note 6: Small Organ: breast, thyroid, testes Note 5: 4D 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) Masa S. Patil 3-8 (Division Sign Off) Division of Office of In and Safety $$K_{112/1} \leq 1$$ 510k Indications For Use {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 | P | P | P | | P | P | Note 1 | Notes 2,4 | | | Abdominal | P | P | P | | P | P | Note1 | 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) | P | P | P | | P | P | Note 1 | Notes 2,4 | | Cardiac | Cardiac Adult | | | | | | | | | |…