Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems

Q: Who is the manufacturer of Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems?

Supersonic Imagine filed the 510(k) submission for Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems (K202455).

Q: What is the FDA product code for Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems?

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

Q: What is the regulatory pathway for Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems?

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

Q: Who can help prepare an FDA 510(k) submission like Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems?

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.

K202455 · Supersonic Imagine · IYN · Dec 29, 2020 · Radiology

Device Facts

Record ID	K202455
Device Name	Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
Applicant	Supersonic Imagine
Product Code	IYN · Radiology
Decision Date	Dec 29, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for: Measurements of abdominal anatomical structures, Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen Measurements of brightness ratio between liver and kidney, Visualization of abdominal vascularization, microvascularization and perfusion, Quantification of abdominal vascularization and perfusion. The shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. The supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent.

Device Story

Cart-based ultrasound diagnostic system; utilizes various linear, curved, microconvex, and phased array transducers. Inputs: ultrasonic pulse-echo signals. Processing: scan converter transforms signals into images displayed on LCD monitor; includes B-mode, M-mode, Color/Power Doppler, 3D imaging, CEUS, and elastography (ShearWave/Strain). Output: diagnostic images, measurements, and reports. Used in clinical settings by healthcare professionals. Aids clinical management of liver disease via stiffness/perfusion quantification. Benefits: non-invasive visualization and measurement of anatomical structures and tissue properties.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), acoustic output (NEMA UD-2/UD-3), and biocompatibility (ISO 10993-1).

Technological Characteristics

Cart-based ultrasound system with LCD monitor and control panel. Transducers: linear, curved, microconvex, motorized linear, phased array. Imaging modes: B-mode (harmonic/fundamental), M-mode, Color/Power Doppler, CW/PW Doppler, 3D, CEUS, ShearWave/Strain elastography. Connectivity: digital memory, external printer. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Biocompatibility: ISO 10993-1.

Indications for Use

Indicated for adult and pediatric patients for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, and Doppler fluid flow analysis. Applications include abdominal, small organs, musculoskeletal, superficial musculoskeletal, vascular, peripheral vascular, intraoperative, OB-GYN, pelvic, pediatric, urology, trans-rectal, trans-vaginal, neonatal/adult cephalic, and non-invasive cardiac imaging. Specific liver disease management includes measurements of shear wave speed, tissue stiffness, brightness ratio, and visualization/quantification of vascularization and perfusion.

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

AIXPLORER® MACH 20, AIXPLORER® MACH 30 Ultrasound Diagnostic Systems (K191007)

Related Devices

K180572 — AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 · Supersonic Imagine · May 29, 2018
K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems · Supersonic Imagine · Oct 25, 2019
K171105 — AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems · Supersonic Imagine · Jul 11, 2017
K173021 — Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems · Supersonic Imagine · Jan 9, 2018
K142100 — AIXPLORER · Supersonic Imagine · Nov 20, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". December 29, 2020 SuperSonic Imagine % Jacques Souquet Chief Innovation Officer Les Jardins de la Duranne - Bât. E&F 510. rue René Descartes 13857 Aix-en-Provence Cedex FRANCE Re: K202455 Trade/Device Name: AIXPLORER® MACH 20, AIXPLORER® MACH 30, SUPERSONIC MACH40, SUPERSONIC MACH30 & SUPERSONIC MACH20 Ultrasound Diagnostic Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 12, 2020 Received: December 18, 2020 Dear Jacques Souquet: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202455 ### Device Name AIXPLORER® MACH 20, AIXPLORER® MACH 30, SUPERSONIC MACH40, SUPERSONIC MACH30 & SUPERSONIC MACH20 Ultrasound Diagnostic Systems ### Indications for Use (Describe) The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for: Measurements of abdominal anatomical structures, Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen Measurements of brightness ratio between liver and kidney, Visualization of abdominal vascularization, microvascularization and perfusion, Quantification of abdominal vascularization and perfusion. The shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. The supported clinical applications for contrast enhancement imaging does not constitute permission to do such imaging beyond the scope of the contrast agent. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Device Name: AIXPLORER® MACH 30 (SSIP95030) , AIXPLORER® MACH 20 (SSIP95020), SUPERSONIC MACH30 (SSIP95030-HOLX), SUPERSONIC MACH20 (SSIP95020-HOLX) & SUPERSONIC MACH40 (SSIP95040) Ultrasound Diagnostic Systems Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | | | | | | | | |---------------------------|---------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------------|------------------------------------------------------------------| | General (Track 1 Only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | P | | P | | P : 5, 6, 10 | | Fetal Imaging & Other | Fetal | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 11,13, 14, 15, 16 - N: 21,22 | | | Abdominal (including urolology): Liver, Kidney, Spleen... | P | P | P | | P | P : 1, 3, 4 | P: 5, 6, 8, 9 | | | Intra-operative (Specify) vascular, abdominal, small organs | P | | P | | P | P : 1, 3, 4 | P: 5, 6, 8, 9 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 11, 13, 15, 16 - N: 14, 18, 19, 21, 20 | | | Small Organ (Breast, Thyroid, Testicle, Prostate, penis, etc...) | P | | P | | P | P : 1, 2, 3, 4,12 | P: 5, 6, 7, 8, 9, 10, 14, 15, 18, 19, 20, 21 N : 13 | | | Neonatal Cephalic | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 9 | | | Adult Cephalic | P | | P | | P | P : 1, 3, 4 | P : 5, 6 | | | Trans-rectal | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8 N : 13 | | | Trans-vaginal | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 11 N : 13 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 14, 15,19, 20 N : 13 | | | Musculo-skeletal (Superficial) | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 14, 15,19, 20 N : 13 | | | Intravascular | | | | | | | | | | GYN | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8 11, 14 N : 13 | | | Pelvic | P | P | P | | P | P : 1, 2, 3, 4 | P: 5, 6, 7, 8,11, 14 N : 13 | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | P | P | P | P | P | P : 1, 3, 4, 11, 17, 18 | P : 5 | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral | Peripheral vessel | P | | P | | P | P : 1, 3, 4 | P : 5, 6, 8, 9, 10, 15 N : 13 | | Vessel | Other (Specify) | P | | P | | P | P : 1, 3, 4 | P : 5, 6, 8, 9, 10, 15 N : 13 | N = new indication; P = Previously cleared by FDA (K191007) 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 9: Panoramic Imaging 8: Imaging Guidance for Biopsies 2: Combined modes include: B+ ShearWave™ Elastography 4: Combined modes include: B+ Pulsed Wave + Color Flow 10: 3D Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode TM Elastography 12: Combined modes include: B Mode + Color flow + Shearwave 12. Combined modes in Enhancement | UltraSound Enhancement Ultrasound 13: CEUS (Contrast) Enhancement UltraSound) 13: CEUS (Contrast) 14: Angio PL.U.S (Color Doppler improvement) 15: Needle 14: Angio PL.U.S (Color Doppler improvement) 15: Needle 16: Brightnes PL.U.S 10-B-14 17: Combined mode include: B+ Continuous Wave 18: Combined mode include: B+ M mode + Color flow 19: Strain Elastography 20: Combined mode: B Mode + Strain + SWE 21: Vi PLUS 22: Att PLUS & SSp PLUS 20. Combined mode: B Mode + Strain + SWE 21. 21. AU-DIUC & CO-DIUC 22: Att PLUS & SSp PLUS {4}------------------------------------------------ Device Name: L10-2 transducer (linear transducer, SSIP95103) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: N = new indication; P = Previously cleared by FDA (K191007) 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 3: Combined modes include: B+ Pulsed Wave - 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging - 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 15: Needle PL.U.S 16: Brightness ratio 17: Combined mode include: B+ Continuous Wave - 18: Combined mode include: B+ M mode + Color flow - 19: Strain Elastography - 20: Combined mode: B Mode + Strain + SWE - 21: Vi PLUS 22: Att PLUS & SSp PLUS Clinical Application Mode of Operation в M |PWD|CWD General Specific Color Combined Other* (Specify) (Track 1 Only) (Tracks 1 & 3) Doppler (Specify) Ophthalmic Ophthalmic Fetal Fetal Imaging & Other P Abdominal (including urolology): Liver, P P P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9, 13,14, 15, Kidney, Spleen ... 16 - N: 21,22 Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric P P P P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9,14, 15, 16, 21, 22 N : 13 Small Organ (for example Breast, Thyroid, P P P P: 1, 2, 3, 4, P: 5, 6, 7, 8, 9, 14, 15,20, Testicle, Prostate, penis, etc ... ) 21, 22 12 N : 13 P P P Neonatal Cephalic N, 1, 2, 3, 4 N, 5, 6, 7, 9 Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) P P P Musculo-skeletal (Conventional) P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9, 14,15,20 N : 13 P Musculo-skeletal (Superficial) P P P: 1, 2, 3, 4 P: 5, 6, 7, 8, 9, 14, 15,20 N : 13 Intravascular GYN Pelvic Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel P P P P: 1, 3, 4 P: 5, 6, 8, 9, 15 N : 13 P Other (Specify) P P P: 5, 6, 8, 9, 15 Vessel P: 1, 3, 4 N : 13 {5}------------------------------------------------ 510(k) Number (if known): Device Name: C6-1X transducer (curved array transducer, SSIP95101) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, 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 | Combined (Specify) | Other* (Specify) | | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal Imaging & Other | Fetal | P | P | P | | P | P: 1, 3, 4, 11 | P: 5, 6 | | | | Abdominal (including urolology), Liver, Kidney, Spleen. | P | P | P | | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8, 9, 13, 14, 16, 21, 22 | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13, 14, 16, 21, 22 | | | | Small Organ (Breast, Thyroid, Testicle, Prostate, penis, etc...) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8 N: 13 | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | GYN | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8,11,14 N: 13 | | | | Pelvic | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 11,14 N: 13 | | | | Other (Specify) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral | Peripheral vessel | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8 N: 13 | | | Vessel | Other (Specify) | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8 N: 13 | | | Clinical Application | | | Mode of Operation | | | | | | | | General (Track 1 Only) | Specific (Tracks 1 & 3) | | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal Imaging & Other | Fetal | | P | P | P | | P | P: 1, 3, 4, 11 | P: 5, 6 | | | Abdominal (including urolology): Liver, Kidney, Spleen... | | P | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8 N : 13 | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8 N : 13 | | | Trans-vaginal | | P | P | P | | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8 N : 13 | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | GYN | | P | P | P | P | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8 N : 13 | | | Pelvic | | P | P | P | P | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8 N : 13 | | | Other (Specify) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | Other (Specify) | | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8 N : 13 | N = new indication; P = Previously cleared by FDA (K191007) Additional Comments: - 1: Combined modes include: B+ Color Flow - 2: Combined modes include: B+ ShearWave™ Elastography - 3: Combined modes include: B+ Pulsed Wave - 4: Combined modes include: B+ Pulsed Wave + Color Flow - 5: Harmonic Imaging - 6: Spatial Compounding - 7: ShearWave™ Elastography - 8: Imaging Guidance for Biopsies - 9: Panoramic Imaging - 10: 3D Imaging - 11: Combined modes include: B+ M mode - 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography - 13: CEUS (Contrast Enhancement UltraSound) - 14: Angio PL.U.S (Color Doppler improvement) - 15: Needle PL.U.S - 16: Brightness ratio - 17: Combined mode include: B+ Continuous Wave - 18: Combined mode include: B+ M mode + Color flow - 19: Strain Elastography - 20: Combined mode: B Mode + Strain + SWE - 21: Vi PLUS - 22: Att PLUS & SSp PLUS {6}------------------------------------------------ 510(k) Number (if known): Device Name: E12-3 transducer (endocavitary transducer, SSIP95102) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: N = new indication; P = Previously cleared by FDA (K191007) 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 3: Combined modes include: B+ Pulsed Wave - 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode - 14: Angio PL.U.S (Color Doppler improvement) 15: Needle PL.U.S 16: Brightness ratio 17: Combined mode include: B+ Continuous Wave 18: Combined mode include: B+ M mode + Color flow 19: Strain Elastography - 20: Combined mode: B Mode + Strain + SWE - 21: Vi PLUS - 22: Att PLUS & SSp PLUS {7}------------------------------------------------ 510(k) Number (if known): Device Name: LV16-5 transducer (motorized linear transducer, SSIP95108) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, 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 | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | Abdominal (including urolology): Liver, Kidney, Spleen... | P | | P | P | | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | P | P | P | | | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | P | | | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 | | | Musculo-skeletal (Superficial) | P | P | P | | | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | | P: 1, 3, 4 | P: 5, 6, 8, 9, 10 | | | Other (Specify) | | | | | | | | N = new indication; P = Previously cleared by FDA (K191007) 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 15: Needle PL.U.S 16: Brightness ratio 17: Combined mode include: B+ Continuous Wave 18: Combined mode include: B+ M mode + Color flow 19: Strain Elastography 20: Combined mode: B Mode + Strain + SWE 21: Vi PLUS 22: Att PLUS & SSp PLUS {8}------------------------------------------------ 510(k) Number (if known): Device Name: MC12-3 transducer (micro-curved transducer, SSIP95106) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, 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 | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | Abdominal (including urolology): Liver, Kidney, Spleen... | P | | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13 | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | P | | P | | | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9 | | | Neonatal Cephalic | P | | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9 | | | Musculo-skeletal (Superficial) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | P | P | P | | P | P: 1,3,4,11 | P: 5, 6 | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8, 9 | | | Other (Specify) | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8, 9 | N = new indication; P = Previously cleared by FDA (K191007) 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 15: Needle PL.U.S 16: Brightness ratio 17: Combined mode include: B+ Continuous Wave 18: Combined mode include: B+ M mode + Color flow 19: Strain Elastography 20: Combined mode: B Mode + Strain + SWE 21: Vi PLUS 22: Att PLUS & SSp PLUS {9}------------------------------------------------ 510(k) Number (if known): #### Device Name: P5-1X transducer (Phased Array transducer, SSIP95107) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, 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 | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | Abdominal (including urolology): Liver, Kidney, Spleen... | P | P | P | P | P | P: 1, 3, 4, 11, 17 | P: 5, 6, 16 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | P | P | | P | | P: 1, 3, 4 | P: 5, 6 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | P | P | | P | | P: 1, 3, 4 | P: 5, 6 | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | P | P | P | P | P | P : 1, 3, 4, 11, 17, 18 | P: 5, 6 | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | P: 1, 3, 4, 17 | P: 5, 6 | | | Other (Specify) | P | P | P | P | P | P: 1, 3, 4, 17 | P: 5, 6 | N = new indication; P = Previously cleared by FDA (K191007) 1: Combined modes include: B+ Color Flow 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 15: Needle PL.U.S 16: Brightness ratio 17: Combined mode include: B+ Continuous Wave 18: Combined mode include: B+ M mode + Color flow 19: Strain Elastography 20: Combined mode: B Mode + Strain + SWE 21: Vi PLUS 22: Att PLUS & SSp PLUS 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode {10}------------------------------------------------ 510(k) Number (if known): Device Name: LH20-6 transducer (linear transducer, SSIP95104) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, 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 | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | Abdominal (including urolology): Liver, Kidney, Spleen... | | | | | | | | | | Intra-operative (Specify) Vascular, abdominal, small organs | P | P | P | | P | P: 1, 3, 4 | P: 5, 6, 9, 15 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9, 15 | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9, 15 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9, 15 | | | Musculo-skeletal (Superficial) | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9, 15 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | P | P: 1, 3, 4 | P: 5, 6, 9, 15 | | | Other (Specify) | P | P | P | | P | P: 1, 3, 4 | P: 5, 6, 9, 15 | N = new indication; P = Previously cleared by FDA (K191007) 2: Combined modes include: B+ ShearWave™ Elastography 4: Combined modes include: B+ Pulsed Wave + Color Flow 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 15: Needle PL.U.S 16: Brightness ratio 17: Combined mode include: B+ Continuous Wave 18: Combined mode include: B+ M mode + Color flow 19: Strain Elastography 20: Combined mode: B Mode + Strain + SWE 21: Vi PLUS 22: Att PLUS & SSp PLUS 9: Panoramic Imaging 10: 3D Imaging 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 11: Combined modes include: B+ M mode 4. Angio P.L.U.S (Color Doppler Im 5: Needle P.L.U.S {11}------------------------------------------------ 510(k) Number (if known): #### Device Name: L18-5 transducer Linear Array transducer, SSIP95100) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, 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 | Combined (Specify) | Other* (Specify) | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | | | Abdominal (including urology): Liver, Kidney, Spleen... | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14, 15 | | | | | Intra-operative (Specify) | | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Pediatric | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14, 15 | | | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, Penis) | P | | P | | P | P: 1, 2, 3, 4, 12 | P: 5, 6, 7, 8, 9, 14 – N: 19, 20 | | | | | Neonatal Cephalic | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9 | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | | Musculo-skeletal (Conventional) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9,14, 15 – N: 19, 20 | | | | | Musculo-skeletal (Superficial) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9,14, 15 – N: 19, 20 | | | | | Intravascular | | | | | | | | | | | | GYN | | | | | | | | | | | | Pelvic | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 | | | | | Other (Specify) | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 | | | N = new indication; P = Previously cleared by FDA (K180572) 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 3: Combined modes include: B+ Pulsed Wave - 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 15: Needle PL.U.S 16: Brightness ratio 17: Combined mode include: B+ Continuous Wave 18: Combined mode include: B+ M mode + Color flow 19: Strain Elastography 20: Combined mode: B Mode + Strain + SWE 21: Vi PLUS - 22: Att PLUS & SSp PLUS {12}------------------------------------------------ 510(k) Number (if known): Device Name: C9-2X transducer Curved Array transducer, SSIP95105) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, 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 | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | P | P | P | | P | P: 1, 3, 4, 11 | P: 5, 6 | | Other | Abdominal (including urology): Liver, Kidney, Spleen... | P | P | P | | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8, 9, 13, 14, 16 - N: 21, 22 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | |…