Aixplorer

K161999 · Supersonic Imagine · IYN · Nov 16, 2016 · Radiology

Device Facts

Record IDK161999
Device NameAixplorer
ApplicantSupersonic Imagine
Product CodeIYN · Radiology
Decision DateNov 16, 2016
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1550
Device ClassClass 2
AttributesPediatric

Intended Use

Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: 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. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).

Device Story

Cart-based ultrasound system; acquires ultrasound data via various transducers (linear, curved, micro-convex, motorized linear, phased array); displays data on LCD monitor. Operates in B-mode, M-mode, Color Flow (including Amplitude Doppler, dCPI, Angio PL.U.S), Pulsed Wave Doppler, 3D imaging, and ShearWave™ Elastography. Used in clinical settings by healthcare professionals for non-invasive diagnostic imaging, anatomical measurements, and biopsy guidance. System processes inputs to provide real-time visualization and quantitative measurements; aids clinicians in diagnostic decision-making and patient management.

Clinical Evidence

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

Technological Characteristics

Cart-based system with LCD monitor, control panel, and touch screen. Transducers: linear, curved, micro-convex, motorized linear, phased array. Imaging modes: B-mode, M-mode, Color Flow, Pulsed Wave Doppler, 3D, ShearWave™ 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 diagnostic ultrasound imaging, soft tissue elasticity, and fluid flow analysis in abdominal, small organ, musculoskeletal, vascular, peripheral vascular, intraoperative, OB-GYN, pelvic, pediatric, urological, trans-rectal, trans-vaginal, neonatal/adult cephalic, and non-invasive cardiac applications.

Regulatory Classification

Identification

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

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a ribbon-like design representing the snakes. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 16, 2016 SuperSonic Imagine, S.A. % Mr. Jacques Souquet Chief Innovation Officer Les Jardins de la Duranne - Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex FRANCE Re: K161999 Trade/Device Name: AIXPLORER® Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 8, 2016 Received: November 9, 2016 Dear Mr. 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. 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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. Michael O'Hara For 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}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K161999 Device Name AIXPLORER® Ultrasound Diagnostic System Indications for Use (Describe) The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: 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. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac). | Type of Use ( <i>Select one or both, as applicable</i> ) | |----------------------------------------------------------| |----------------------------------------------------------| 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 Druq 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: AIXPLORÉR® Ultrasound System Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other* (Specify) | |---------------------------|---------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|---------------------------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | | Ophthalmic | Ophthalmic | P | P | P | P | P | P, 1, 3, 4, 11 | P, 5, 6, 10 | | Fetal Imaging &<br>Other | Fetal | P | N | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10, 11 - N<br>13,14 | | | Intra-operative (Specify) vascular,<br>abdominal, small organs | P | | P | | P | P, 1, 3, 4 | P, 5, 6, 9 | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 | | | Small Organ (Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | P | P | P | P | P, 1, 2, 3, 4 - N 12 | P, 5, 6, 7, 8, 9, 10- N 14 | | | Neonatal Cephalic | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 9 | | | Adult Cephalic | P | P | P | P | P | P, 1, 3, 4 | P, 5, 6 | | | Trans-rectal | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5,6, 7, 8 | | | Trans-vaginal | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8 - N 10, 11 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Card.) | | | | | | | | | | Musculo-skeletal (Conventional) | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 - N14 | | | Musculo-skeletal (Superficial) | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9, 10 - N14 | | | Intravascular | | | | | | | | | | GYN | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 11, 14 | | | Pelvic | P | P | P | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 10, 11, 14 | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | N | N | N | N | N | N 1, 3, 4, 5, 11 | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9, 10 | | | Other (Specify) | P | P | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 | N = new indication; P = previously cleared by FDA (K142100) Additional Comments: 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Eastography 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 7: ShearWave™Eastography 8: Imaging Guidance for Biopsies Prescription Use X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging 10: 3D Imaging 11: Combined modes include: B+ M modes 12: Combined modes include: B Mode + Color flow + Shearw ave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 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}------------------------------------------------ Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) # Diagnostic Ultrasound Indications for Use 510(k) Number (if known): Device Name: SL15-4 transducer (1D Linear Array Transducer) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|-------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|--------------------|-----------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Fetal | | | | | | | | | | Other | Abdominal | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 - N14 | | | 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,<br>Thyroid, Testicle, Prostate, Penis) | P | | P | | P | P 1, 2, 3, 4 - N12 | P 5, 6, 7, 8, 9 - N14 | | | 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 - N14 | | | Musculo-skeletal (Superficial) | P | | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 - N14 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | 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, 9 | | Vessel | Other (Specify) | N | | N | | N | N 1, 3, 4 | N 5, 6, 8, 9 | N = new indication; P = previously cleared by FDA (K142100) Additional Comments: 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging 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 8: Imaging Guidance for Biopsies Prescription Use X (Part 21 CFR 801 Subpart D) 9: Panoramic Imaging 0. 3D Imaging 1. Combined modes include: B + M mode 11: Combined modes include: B+ M modes 12: Combined modes include: Color flow +Shearw ave™ Eastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {5}------------------------------------------------ ### Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use 510(k) Number (if known): Device Name: SC6-1 transducer (curved array transducer) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|---------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P, 1, 3, 4, 11 | P, 5, 6 | | Other | Abdominal (including urology) | P | N | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9 - N11 | | | 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,<br>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<br>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 (K142100) Additional Comments: 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding ™ 6: Spatial Compounding 7: ShearWave"MElastography 8: Imaging Guidance for Biopsies 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 11: Combined modes include: B+ M modes 12: Combined modes include: Color flow +Shearw ave™ Elastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) | Prescription Use | X | AND/OR | |-----------------------------|---|--------| | (Part 21 CFR 801 Subpart D) | | | Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {6}------------------------------------------------ 510(k) Number (if known): Device Name: SE12-3 transducer (endocavitary transducer) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation | | | | | | | |---------------------------|---------------------------------------------------------------------------------|--|-------------------|---|-----|-----|------------------|-----------------------|------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal Imaging &<br>Other | Fetal | | P | P | P | | P | P 1, 3, 4, 11 | P 5, 6 | | | Abdominal | | | | | | | | | | | Intra-operative (Specify) | | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | | P | P | | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | P | P | | P | P | P 1, 2, 3, 4 | P 5, 6, 7, 8 | | | Trans-vaginal | | P | P | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 11 | | | 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 | | | Pelvic | | P | P | P | | P | P 1, 2, 3, 4 | P 5, 6, 7, 8, 11 | | | Other (Specify) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | | Intra-cardiac | | | | | | | | | | | Other (Specify) | | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | P | | P | | P | P 1, 3, 4 | P 5, 6, 8 | | | Other (Specify) | | | P | | | | | | N = new indication; P = previously cleared by FDA (K142100) Additional Comments: 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 6: Spatial Compounding 7: ShearWave™Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 11: Combined modes include: B+ M modes 12: Combined modes include: Color flow +Shearw ave™ Eastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) ShearWave ™ Elastography 8: Imaging Guidance for Biopsies Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR {7}------------------------------------------------ 510(k) Number (if known): Device Name: SLV16-5 transducer (motorized linear transducer) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging &<br>Other | Fetal | | | | | | | | | | Abdominal | P | 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 | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 | | | Small Organ (for example Breast,<br>Thyroid, Testicle, Prostate, penis,<br>etc...) | P | 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 | P 1, 2, 3, 4 | P 5, 6, 7, 8, 9, 10 | | | Musculo-skeletal (Superficial) | P | 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<br>Vessel | Peripheral vessel | P | P | P | | P | P 1, 3, 4 | P 5, 6, 8, 9, 10 | | | Other (Specify) | | | | | | | | N = new indication; P = previously cleared by FDA (K142100) Additional Comments: 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 6: Spatial Compounding 7: ShearWave™Elastography 8: Imaging Guidance for Biopsies AND/OR | Prescription Use | X | |-----------------------------|---| | (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 807 Subpart C) 12: Combined modes include: Color flow +Shearw ave™ Eastography 11: Combined modes include: B+ M modes 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 9: Panoramic Imaging {8}------------------------------------------------ 510(k) Number (if known): Device Name: SL10-2 transducer (linear transducer) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | |---------------------------|---------------------------------------------------------------------------------|---|---|-----|-----|------------------|-----------------------|----------------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | | | | | | | | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& Other | Fetal | | | | | | | | | | Abdominal | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 - N 13,14 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | | | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | P | | P | P | P, 1, 2, 3, 4<br>N 12 | P, 5, 6, 7, 8, 9 - N14 | | | 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 | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 - N14 | | | Musculo-skeletal (Superficial) | P | P | | P | P | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 - N14 | | | Intravascular | | | | | | | | | | GYN | | | | | | | | | | Pelvic | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | P | | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 | | | Other (Specify) | P | P | | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 | | | N = new indication; P = previously cleared by FDA (K142100) | | | | | | | | Additional Comments: Additional Comments: 1: Combined modes include: B 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging 2. Combined modes include: B+ Shear wave Elastic 3. Combined modes include: B+ Pulse Wave 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 7: Shearwave Elastography 8: Imaging Guide for Biopsy 8: Imaging Guidance for Biopsies 12: Combined modes include: Color flow +Shearw ave™ Eastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) 9: Panoramic Imaging g : ShearWave™ Elastography 8: Imaging Guidance for Biopsies Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 807 Subpart C) Over-The-Counter Use 11: Combined modes include: B+ M modes (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) {9}------------------------------------------------ 510(k) Number (if known): Device Name: SMC12-3 transducer (micro-curved transducer) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |---------------------------|---------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& Other | Fetal | | | | | | | | | | Abdominal | P | | 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 | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | | | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | | P | 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 | P, 1, 2, 3, 4 | P, 5, 6, 7, 8, 9 | | | Musculo-skeletal (Superficial) | P | | 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<br>Vessel | Peripheral vessel | P | | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 | | | Other (Specify) | P | | P | P | P | P, 1, 3, 4 | P, 5, 6, 8, 9 | N = new indication; P = previously cleared by FDA (K142100) Additional Comments: 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™Elastography 10: 3D Imaging 3: Combined modes include: B+ Pulsed Wave 4: Combined modes include: B+ Pulsed Wave + Color Flow 5: Harmonic Imaging 6: Spatial Compounding 6: Spatial Compounding 7: ShearWave™Elastography 8: Imaging Guidance for Biopsies 9: Panoramic Imaging 11: Combined modes include: B+ M modes 12: Combined modes include: Color flow +Shearw ave™ Eastography 13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement) ShearWave™ Elastography 8: Imaging Guidance for Biopsies Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR {10}------------------------------------------------ 510(k) Number (if known): Device Name: XP5-1 transducer (Phased Array transducer) Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation | | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-----|-----|---------------------|------------------------|--------------------| | General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& Other | Fetal | | | | | | | | | | Abdominal | P | | P | P | P | P 1, 3, 4 | P 5, 6 | | | Intra-operative (Specify) | | | | | | | | | | Intra-operative (Neuro) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | | P | P | P | P 1, 3, 4 | P 5, 6 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | P | | 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 | N | N | N | N | N | N 1, 3, 4, 5,<br>11 | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | |…
Innolitics
510(k) Summary
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