Who is the manufacturer of AIXPLORER?

Supersonic Imagine filed the 510(k) submission for AIXPLORER (K132171).

What is the FDA product code for AIXPLORER?

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

What is the regulatory pathway for AIXPLORER?

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

What are the predicate devices for AIXPLORER?

AIXPLORER® Ultrasound Imaging System (K121329); AIXPLORER® Ultrasound Imaging System (K112255); Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786); Philips iU22 Ultrasound System (K093563).

Who can help prepare an FDA 510(k) submission like AIXPLORER?

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.

AIXPLORER

K132171 · Supersonic Imagine · IYN · Sep 24, 2013 · Radiology

Device Facts

Record ID	K132171
Device Name	AIXPLORER
Applicant	Supersonic Imagine
Product Code	IYN · Radiology
Decision Date	Sep 24, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal Cephalic. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal, Neonatal Cephalic, Fetal/Obstetrics).

Device Story

The Aixplorer® is a cart-based ultrasound system for non-invasive diagnostic imaging. It utilizes various linear, curved, micro-convex, and motorized linear array transducers to acquire ultrasound signals. The system features a scan converter to process these signals into images displayed on an LCD monitor. Users operate the system via an adjustable control panel and integrated touch screen to perform exams, measurements, and generate reports. It supports multiple imaging modes: B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging, and ShearWave™ elastography. The device is intended for use by healthcare professionals in clinical settings. Output is used for diagnostic assessment and clinical decision-making. Benefits include non-invasive visualization of internal structures and blood flow, aiding in the diagnosis and management of various conditions across multiple clinical specialties.

Clinical Evidence

No clinical data was required for this submission. Substantial equivalence was established through non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output measurement (NEMA UD-2, UD-3), and biocompatibility (ISO 10993-1). Performance testing confirmed that the system meets all pre-determined product specifications and safety standards.

Technological Characteristics

Cart-based ultrasound system with LCD monitor and control panel. Supports linear, curved, micro-convex, and motorized linear array transducers. Imaging modes: B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D, and ShearWave™ elastography. Patient-contact materials comply with ISO 10993-1. Electrical safety per IEC 60601-1, IEC 60601-2-37. Acoustic output per NEMA UD-2 and UD-3. Connectivity includes digital memory and external device support (e.g., printer).

Indications for Use

Indicated for diagnostic ultrasound imaging and Doppler fluid flow analysis in abdominal, small organs, musculoskeletal, superficial musculoskeletal, vascular, peripheral vascular, OB-GYN, pelvic, pediatric, urology, trans-rectal, trans-vaginal, and neonatal cephalic applications. Includes anatomical measurements for these areas plus fetal/obstetrics.

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 (K121329)
AIXPLORER® Ultrasound Imaging System (K112255)
Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786)
Philips iU22 Ultrasound System (K093563)

Submission Summary (Full Text)

{0}------------------------------------------------ K132171 Page 1 of 5 ## 510(k) Summary of Safety and Effectiveness This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92. 1) Submitter's name, address, telephone number, contact person Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne - Bât. E & F 510 rue René Descartes 13857 Aix-en-Provence Cedex France Telephone: +33 442 99 24 24 Distributed by: SuperSonic Imagine, Inc. 11714 North Creek Parkway N Suite 150 Bothell, WA 98011 North America Telephone: +1(425) 686 6380 SEP 24 2013 Corresponding Official: Jacques Souquet Chief Executive Officer Telephone: +33 442 99 24 35 Date: 2013/07/12 - 2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known: Common/Usual Name: Diagnostic Ultrasound System with Accessories Proprietary Name: Aixplorer® Classification: Regulatory Class: II | Classification Name: | 21 CFR Section | Product Code | |------------------------------------------|----------------|--------------| | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | ### 3) Substantially Equivalent/Predicate Devices AIXPLORER® Ultrasound Imaging System (K121329), cleared on 08/24/2012 AIXPLORER® Ultrasound Imaging System (K112255), cleared on 08/28/2012 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010 {1}------------------------------------------------ ### 4) Description of Device The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with inteorated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, caplure images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices for the imaging modes: B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography. ### 5) Intended Use The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal Cephalic. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal, Neonatal Cephalic, Fetal/Obstetrics). | | Philips iu22 (predicate K093563): | Siemens Acuson S2000 ™ (predicate K072786) | SuperSonic Imagine AIXPLORER® (predicate K121329) | SuperSonic Imagine AIXPLORER® (predicate K112255) | SuperSonic Imagine AIXPLORER® (submission- device) | |------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | --** | General Radiology | --** | --** | --** | | | Abdominal, Small Organs* | Identical | Identical | Identical | Identical | | | Musculoskeletal | Identical | Identical | Identical | Identical | | | -- | Superficial Musculoskeletal | Identical | Identical | Identical | | | Fetal | Identical | -- | -- | Identical | | Clinical Applications | -- | Transcranial | -- | -- | -- | | | -- | OB | -- | -- | Identical | | | -- | GYN | Identical | Identical | Identical | | | Cardiac | Identical | -- | -- | -- | | | -- | Pelvic | Identical | Identical | Identical | | | Adult and neonatal cephalic | Identical | Identical (for neonatal cephalic) | -- | Identical (for neonatal cephalic) | | | Pediatric | Identical | Identical | Identical | Identical | | | Urology | Identical | Identical | ldentical | Identical | | | | Vascular | ldentical | Identical | Identical | | | Peripheral Vascular | Identical | Identical | Identical | Identical | | | Ophthalmic | t --- | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---- | | | Intra-operative | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --- | | | Laparoscopic | --- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --- | | | Trans-rectal | ---- | Identical | Identical | ldentical | | | Trans-vaginal | ﺴﻌ | ldentical | Identical | ldentical | | | Fetal echo | ーーー | | ---- | Identical | | | | | | | | | lmaging Modes | | | | | | | | B-mode, | Identical | Identical | Identical | Identical | | | M-mode, | Identical | | --- | Identical | | | PW. | Identical | Identical | Identical | ldentical | | Conventional | CW (continuous Wave), | Identical | --- | --- | ---- | | | Color Doppler, | ldentical | Identical | Identical | Identical | | | Amplitude Doppler | ldentical | ldentical | Identical | Identical | | | Harmonic imaging, Spatial | Identical | Identical | Identical | Identical | | Other | Compounding, Panoramic, | Identical | ldentical | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Identical | | | Contrast | Identical | | ---- | --- | | | --- | Identical | Identical | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | --- | Elastography | ldentical | ldentical | Identical | | | B-mode+Color, | Identical, | Identical | ldentical | ldentical | | | B-mode+Color+ PW | Identical | Identical | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Identical | | Combination | B-mode +PW | Identical | Identical | ldentical | İdentical | | | B-mode+M- mode | Identical | --- | ーーー | Identical | | | | B- mode+Elastography | Identical | Identical | Identical | | | | | | | | | Transducers | | | | | | | | Linear Array | Identical | ldentical | Identical | Identical | | Transducer | Curved Array | Identical | Identical | ldentical | Identical | | types | Phased Array | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | - | - | - | | | Laparoscopic probe | | | --- | --- | | | Motorized Linear Probe Microconvex probe | Identical | Identical | Identical | Identical | | | | | | | | | Track | Track 3 (Acoustic Output Display) | Identical | Identical | Identical | Identical | | Patient Contact Materials | Yes, per ISO- 10993- 1 | Identical | Identical | Identical | Identical | | Acoustic Output within FDA guidelines | Yes, as per NEMA UD-3 | Identical | Identical | Identical | Identical | | General Safety | Conforms to IEC 60601-1, IEC 60601-2 | Identical | Identical | Identical | Identical | ## 6) Summary of Technological Characterisitics - New Device compared to Predicates SUPERSONIC IMAGINE {2}------------------------------------------------ SUPERSONIC IMAGINE page 3 of 5 {3}------------------------------------------------ Note: *: Breast, Thyroid, Testicle, etc **: ---- means not applicable ## 7) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices. | Reference Standard | Tests Performed | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1 3rd Edition | All applicable electrical, basic safety and essential performance tests. | | UL 60601-1 1st Edition | All applicable electrical, basic safety and essential performance tests specific to the U.S.A. | | IEC 60601-1-1 2nd Edition | All applicable tests pertaining to Medical Electrical Systems. | | IEC 60601-1-2 3rd Edition | All applicable testing pertaining to electromagnetic compatibility. | | IEC 60601-2-37 2nd Edition | All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. | | NEMA UD 2 (Rev. 3) | All tests applicable in order to demonstrate compliance with the "Accoustic Output Measurement Standard for Diagnostic Ultrasound Equipment". | | NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstrate compliance with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment". | | ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 – per the appropriate | SUPERSONIC IMAGINE page 4 of 5 {4}------------------------------------------------ K132171 Page 5 of 5 | | And The Call Property of Children Comments of Children Comments of | . | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---| | program and the company of the first of the can and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution o | | | | | device category. | | | And Income of the program and the first of the first of the first of the first of the first of the first of the first of the first of the first of the first and | www.comment.com/sports/first.com/ship/submit/shop/spaces/article/submit/shop/article/submit/ | | | | | | In addition to the referenced standards testing, performance tests were conducted with respect to Fetal/Obstetrics features. The above testing confirmed that the Aixplorer System performs according to the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of nonclinical testing confirmed the substantial equivalence of the Aixplorer System to the predicate device(s). ### 8) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence Clinical data is not required as the Aixplorer System uses the same technology and principles as predicate devices. ### 9) Conclusion The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2003) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during manufacturing process to ensure compliance with these standards. Consequently, according tests performed, the opinion of SuperSonic Imagine is the submission device is as safe and effective as the predicate devices cited in item 3. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the body of the symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. Public Health Service Food and Drue Administration 10903 New Hampshire Avenue Dicument Control Center - WOBB-GOOD Silver Spring. MID 209-13-0002 September 24, 2013 Supersonic Imagine, S.A. % Mr. Aurelie Gruener Les Jardins de la Duranne 510 Rue René Descartes - Bât. E et F Aix -en-Provence Cedex 13 857 FRANCE Re: K132171 Trade/Device Name: Aixplorer® Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, IYO, ITX Dated: September 3, 2013 Received: September 3, 2013 Dear Mr. Gruener: We have reviewed your Section 510(k) premarket notification of intent 10 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: CDRII does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. This determination of substantial equivalence applies to the following transducers intended for use with the Aixplorer®, as described in your premarket notification: Transducer Model Number | SL15-4 SC6-1 | SE12-3 SLV16-5 | SL10-2 SMC12-3 | |-----------------|-------------------|-------------------| |-----------------|-------------------|-------------------| If your device is classified (sec 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. {6}------------------------------------------------ ## Page 2-Mr. Gruener 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 (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ 510(k) number (if known): 1388 1132171 Device Name: AIXPLORER® Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Indications for Use: The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal Cephalic. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal, Neonatal Cephalic, Fetal/Obstetrics). Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Sm.h.7) (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _______________________________________________________________________________________________________________________________________________________________________ Page 1 of 8 {8}------------------------------------------------ 510(k) number (if known): Device Name: AIXPLORER® Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other (Specify) | |---------------------------|---------------------------------------------------------------------|---|---|-----|-----|---------------|--------------------|----------------------| | General (Track 1 Only) | Specific (Tracks 1 & 3) | | | | | | | | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | N | N | N | N | N | N, 1, 3, 4, 11 | N, 5, 6 | | Other | Abdominal (including urology) | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 | | | Small Organ (Breast, Thyrold, Testicle, Prostate, penis, etc...) | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 | | | Neonatal Cephalic | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8 | | | Trans-vaginal | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 | | | Musculo-skeletal (Superficial) | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 | | | Intravascular | | | | | | | | | | GYN | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10 | | | Pelvic | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10 | | | 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, 2, 3, 4 | P, 5, 6, 7, 8, 10, 9 | | | Other (Specify) | P | | P | | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | N = new indication: P = previously cleared by FDA (K121329) Additional Comments: 1: Combined modes include: B+ Color Flow 1: Combined modes include: B+ Color Mow 2: Combined modes include: B+ ShearWave™ Ei Elastography 3: Combined modes Include: B+ Pulsed Wave X 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging (Parl 21 CFR 801 Subpart D) Prescription Use AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) 11: Combined modes include: B+ M modes 6: Spatial Compounding 7: ShearWave™ Elestography 9: Panoramic Imaging 10: 3D Imaging r. Shearthove Guldance for Biopstes (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) Page 2 o! B {9}------------------------------------------------ 510(k) Number (if known): Device Nams: SL15-4 transducer (1D Linear Array 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 | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal | | | | | | | | | | Abdominal | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | Small Organ (for example Breast, Thyroid, Testicle, Prostate, Penis) | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | 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 | | | 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 | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | Other (Specify) | | | | | | | | | | N = new indication; P = previously cleared by FDA (K121329) | | | | | | | | Additional Comments: 1: Combined modes include: B+ Color Flow 1. Gombined modes include: B+ ShearWave"™ × Elastography 3: Combined modes include: 8+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Hamonic Imaging (Part 21 CFR 801 Subpart D) Prescription Use AND/OR 10: 3D Imaging 11: Combined modes include: B+ M modes 6: Spatial Compounding 7: ShearWave™ Elastography 9: Panoramic Imaging 8: Imaging Guidance for Biopsies 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 Diagnostics and Radiological Health (OIR) Page 3 of 8 {10}------------------------------------------------ 510(k) Number (if known): Device Name: SC6-1 transducar (curved array 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 | P | 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 urology) | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | Small Organ (Breast, Thyroid, Testicle, Prostate, penis, etc...) | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | | | 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 | | | Musculo-skeletal (Superficial) | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | Intravascular | | | | | | | | | | GYN | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | | | Pelvic | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | | | 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, 2, 3, 4 | P 5, 6, 7, 8, 9 | | | Other (Specify) | P | | P | | P | P 1, 2, 3, 4 | P 5, 8, 7, 8, 9 | N = new indication; P = previously cleared by FDA (K121329) Additional Comments: 1; Combined modes include: B+ Color Flow 1: Combined modes include: B+ Color Plow ਮ Elastography 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harnonic Imaging Prescription Use (Part 21 CFR 80) Subpart D) · 11: Combined modes include: B+ M modes AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) 6: Spatial Compounding 7: ShearWave™ Elastography 8: Imaging Guidance for Blopsies 9: Panoramic Imaging 10: 3D Imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUI: ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH: Office of In Vitro Diagnostics and Radiological Health (OIR) Page 4 of B {11}------------------------------------------------ 510(k) Number (if known): Device Name: SE12-3 transducer (endocavitary transducer) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | |…

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