AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10

Q: Who is the manufacturer of AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

Supersonic Imagine filed the 510(k) submission for AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (K180572).

Q: What is the FDA product code for AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

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 MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

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

Q: What are the predicate devices for AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

AIXPLORER® Ultrasound Imaging System (K173021); FibroScan (K160524); Epiq 7 (K163120).

Q: Who can help prepare an FDA 510(k) submission like AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10?

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.

K180572 · Supersonic Imagine · IYN · May 29, 2018 · Radiology

Device Facts

Record ID	K180572
Device Name	AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
Applicant	Supersonic Imagine
Product Code	IYN · Radiology
Decision Date	May 29, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral 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 shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.

Device Story

Cart-based ultrasound system; utilizes various linear, curved, micro-convex, and phased array transducers. Inputs: acoustic signals from human tissue. Processing: scan converter transforms signals into images displayed on LCD monitor. Features: B-Mode, M-mode, Color Flow (CFI, CPI, dCPI, Angio PL.U.S), Pulsed/Continuous Wave Doppler, 3D imaging, CEUS, and ShearWave™ elastography. Operated by clinicians in clinical settings. Output: real-time diagnostic images, measurements, and reports. Clinical utility: aids in anatomical structure visualization, liver disease management (stiffness/perfusion quantification), and biopsy guidance. Benefits: non-invasive diagnostic imaging and quantitative tissue assessment.

Clinical Evidence

Clinical evaluation performed via literature review to support substantial equivalence and expanded indications for use. No new prospective clinical trials were conducted for this submission; safety and effectiveness established through non-clinical bench testing and literature-based clinical evidence.

Technological Characteristics

Cart-based ultrasound system with LCD monitor and adjustable control panel. Transducers: linear, curved, micro-convex, motorized linear, phased array. Patient contact materials compliant with ISO 10993-1. Imaging modes: B-mode, M-mode, Color Flow, PW/CW Doppler, 3D, CEUS, ShearWave™ elastography. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound safety), NEMA UD-2/UD-3 (acoustic output).

Indications for Use

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

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® Ultrasound Imaging System (K173021)
FibroScan (K160524)
Epiq 7 (K163120)

Related Devices

K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems · Supersonic Imagine · Oct 25, 2019
K202455 — Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems · Supersonic Imagine · Dec 29, 2020
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. May 29, 2018 SuperSonic Imagine % Laurence Hermitte Quality & Regulatory Affairs Director Les jardins de la Duranne - Bat E&F - 510 rue Rene Descartes Aix-en-Provence, 13857 FRANCE Re: K180572 Trade/Device Name: AIXPLORER® MACH Ultrasound Diagnostic Systems AIXPLORER® MACH 30, AIXPLORER® MACH 20, AIXPLORER® MACH 10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 8, 2018 Received: March 12, 2018 Dear Laurence Hermitte: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ ### Page 2 - Laurence Hermitte 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'HaraFor Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180572 #### Device Name AIXPLORER MACH Ultrasound Diagnostic Systems AIXPLORER MACH 30, AIXPLORER MACH 20, AIXPLORER MACH 10 Indications for Use (Describe) The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Transrectal, 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 shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### 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}------------------------------------------------ #### 510(k) number (if known): Device Name: AIXPLORER® MACH 30 (SSIP95030), AIXPLORER® MACH 20 (SSIP95020) and AIXPLORER® MACH 10 (SSIP95010) 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 | | | | | | | | | Fetal Imaging & Other | Fetal | N | N | N | N | N | N 1, 3, 4, 11 | N 5, 6, 10 | | | Abdominal (including urolology): Liver, Kidney, Spleen... | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 11,13, 14, 16 | | | Intra-operative (Specify) vascular, abdominal, small organs | N | | N | | N | N 1, 3, 4 | N 5, 6, 8, 9 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 11, 13, 16 | | | Small Organ (Breast, Thyroid, Testicle, Prostate, penis, etc...) | N | | N | | N | N 1, 2, 3, 4,12 | N 5, 6, 7, 8, 9, 10, 14 | | | Neonatal Cephalic | N | | N | | N | N 1, 2, 3, 4 | N 5, 6, 7, 9 | | | Adult Cephalic | N | | N | | N | N 1, 3, 4 | N 5, 6 | | | Trans-rectal | N | | N | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | | | Trans-vaginal | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 11 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | N | | N | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 14 | | | Musculo-skeletal (Superficial) | N | | N | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 14 | | | Intravascular | | | | | | | | | | GYN | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 11, 14 | | | Pelvic | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8,11, 14 | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | N | N | N | N | N | N 1, 3, 4, 11, 17, 18 | N, 5 | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | | N | | N | N, 1, 3, 4 | N, 5, 6, 8, 9, 10 | | | Other (Specify) | N | | N | | N | N, 1, 3, 4 | N, 5, 6, 8, 9, 10 | N = new indication; 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 Prescription Use X (Part 21 CFR 801 Subpart D) 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 Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR {4}------------------------------------------------ 510(k) Number (if known): Device Name: L10-2 transducer (SSIP95103) 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... | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 13,14, 15, 16 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 15, 16 | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | N | N | N | N | N | N, 1, 2, 3, 4, 12 | N, 5, 6, 7, 8, 9, 1415 | | | Neonatal Cephalic | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 9 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 1415 | | | Musculo-skeletal (Superficial) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 1415 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 915 | | | Other (Specify) | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 915 | N = new indication; 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies Additional Comments: 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 3: Combined modes include: B+ Pulsed Wave 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M mode 4: Combined modes include: B+ Pulsed Wave + 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 incluseds: B+ M mode + Color flow Over-The-Counter Use AND/OR Prescription Use X (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 Diagnostics and Radiological Health (OIR) {5}------------------------------------------------ 510(k) Number (if known): Device Name: C6-1X 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 | N | N | N | N | N | N 1, 3, 4, 11 | N 5, 6 | | | Abdominal (including urolology), Liver, Kidney, Spleen. | N | N | N | N | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8, 9, 13,14, 16, | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 13,16 | | | Small Organ (Breast, Thyroid, Testicle, Prostate, penis, etc...) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | GYN | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 14 | | | Pelvic | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 14 | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 8 | | | Other (Specify) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 8 | N = new indication; Additional Comments: 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography - 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging 10. 3D Imaging 11. Combining data 11: Combined modes include: B+ M modes - 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 incluseds: B+ M mode + Color flow Prescription Use X (Part 21 CFR 801 Subpart D) 8: Imaging Guidance for Biopsies - AND/OR - Over-The-Counter Use (21 CFR 807 Subpart C) {6}------------------------------------------------ 510(k) Number (if known): Device Name: E12-3 transducer (SSIP95102) 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 | | N | N | N | | N | N 1, 3, 4, 11 | N 5, 6 | | | Abdominal (including urolology): Liver, Kidney, Spleen... | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | N | N | | N | | N | N1, 2, 3, 4 | N 5, 6, 7, 8 | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | N | N | | N | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | | | Trans-vaginal | | N | N | N | | N | N1, 2, 3, 4, 11 | N5, 6, 7, 8 | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | | | | | | | | | | | Musculo-skeletal (Superficial) | | | | | | | | | | | Intravascular | | | | | | | | | | | GYN | | N | N | N | | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8 | | | Pelvic | | N | N | N | | N | N1, 2, 3, 4, 11 | N 5, 6, 7, 8 | | | Other (Specify) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | Other (Specify) | N | | N | | | N | N 1, 3, 4 | N 5, 6, 8 | N = new indication; N 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 15. Needle / L.O. 16. Brightness ra 16. Brightness ratio 17. Combined mode include 17. Combined mode include: B+ Continuous Wave 18. Combined mode include: B+ M mode + Color Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M modes 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography Liistography 13. CEUS (Con 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 incluseds: B+ M mode + Color flow AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) {7}------------------------------------------------ 510(k) Number (if known): Device Name: LV16-5 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... | N | N | N | N | | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | N | | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | | | Small Organ (for example Breast, N Thyroid, Testicle, Prostate, penis, etc...) | N | N | N | N | | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | N | | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | | | Musculo-skeletal (Superficial) | N | N | N | N | | N 1, 2, 3, 4 | N 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 | N | N | N | N | | N 1, 3, 4 | N 5, 6, 8, 9, 10 | | | Other (Specify) | | | | | | | | N = new indication; Additional Comments: 5: Harmonic Imaging - 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography 3: Combined modes include: B+ Pulsed Wave 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M modes 12: Combined modes include: B Mode + Color flow + Shearwave™ - 4: Combined modes include: B+ Pulsed Wave + Color Flow 6: Spatial Compounding 7: ShearWave™ Elastography - 8: Imaging Guidance for Biopsies - - 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 incluseds: B+ M mode + Color flow Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) {8}------------------------------------------------ 510(k) Number (if known): Device Name: MC12-3 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... | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 13 | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 13 | | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9 | | | | Neonatal Cephalic | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 9 | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9 | | | | Musculo-skeletal (Superficial) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9 | | | | Intravascular | | | | | | | | | | | GYN | | | | | | | | | | | Pelvic | | | | | | | | | | | Other (Specify) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | N | N | N | N | N | N 1,3,4,11 | N, 5, 6 | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 9 | | | | Other (Specify) | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 9 | | N = new indication; P = previously cleared by FDA (K171105) 4: Combined modes include: B+ Pulsed Wave + Color Flow Additional Comments: 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave 9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging 11: Combined modes include: B+ M modes 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 incluseds: B+ M mode + Color flow X Prescription Use - Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) - (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) {9}------------------------------------------------ 510(k) Number (if known): Device Name: P5-1X 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... | N | N | N | N | N | N 1, 3, 4, 11, 17 | N 5, 6, 16 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | N | N | | N | N | N 1, 3, 4 | N 5, 6 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | N | N | | N | N | N 1, 3, 4 | N 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 | N | N | N | N | N | N 1, 3, 4, 11, 17, 18 | N, 5, 6 | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4, 17 | N 5, 6 | | | Other (Specify) | N | N | N | N | N | N 1, 3, 4, 17 | N 5, 6 | N = new indication; N Additional Comments: 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging 11: Combined modes include: B+ M modes 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 incluseds: B+ M mode + Color flow Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) {10}------------------------------------------------ 510(k) Number (if known): Device Name: LH20-6 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 | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 915 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, penis, etc...) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | | | Musculo-skeletal (Superficial) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 915 | | | Other (Specify) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 915 | N = new indication; 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 Imaqing 10: 3D Imaging 11: Combined modes include: B+ M modes 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 incluseds: B+ M mode + Color flow Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) {11}------------------------------------------------ 510(k) Number (if known): Device Name: L18-5 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 & Fetal Other | Abdominal (including urolology): Liver, Kidney, Spleen... | N | N | | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 1415 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | N | | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 91515 | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, Penis) | N | N | | | N | N 1, 2, 3, 4, 12 | N 5, 6, 7, 8, 9, 14 | | | Neonatal Cephalic | N | N | | | N | N1, 2, 3, 4 | N 5, 6, 7, 9 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | N | N | | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9,1415 | | | Musculo-skeletal (Superficial) | N | N | | | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9,1415 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | | | N | N 1, 3, 4 | N 5, 6, 8, 915 | | | Other (Specify) | N | N | | | N | N 1, 3, 4 | N 5, 6, 8, 915 | N = new indication; Additional Comments: 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Biopsies - 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave 9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging 11: Combined modes include: B+ M modes 4: Combined modes include: B+ Pulsed Wave + 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 incluseds: B+ M mode + Color flow Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) {12}------------------------------------------------ 510(k) Number (if known): Device Name: C9-2X (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 | N | N | N | N | N | N 1, 3, 4, 11 | N 5, 6 | | Other | Abdominal (including urolology): Liver, Kidney, Spleen... | N | N | N | N | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8, 9, 13, 14, 16 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | N | | N | N | N | N…