Who is the manufacturer of RS80 EVO Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for RS80 EVO Diagnostic Ultrasound System (K192030).

What is the FDA product code for RS80 EVO Diagnostic Ultrasound System?

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

What is the regulatory pathway for RS80 EVO Diagnostic Ultrasound System?

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

Does RS80 EVO Diagnostic Ultrasound System use AI or machine learning?

Yes. RS80 EVO Diagnostic Ultrasound System (K192030) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for RS80 EVO Diagnostic Ultrasound System?

RS85 Diagnostic Ultrasound System (K191115).

Who can help prepare an FDA 510(k) submission like RS80 EVO Diagnostic Ultrasound System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like RS80 EVO Diagnostic Ultrasound System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

RS80 EVO Diagnostic Ultrasound System

K192030 · Samsung Medison Co., Ltd. · IYN · Sep 19, 2019 · Radiology

Device Facts

Record ID	K192030
Device Name	RS80 EVO Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Sep 19, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Device Story

RS80 EVO is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers (linear, curved, phased, endocavity, static) and displays it in modes including 2D, M-mode, Color/Power Doppler, PW/CW Spectral Doppler, Tissue Harmonic Imaging, Tissue Doppler, 3D/4D, and Elastoscan. Used in clinical settings by healthcare professionals to visualize anatomical structures and analyze body fluids. The system provides real-time acoustic output display (mechanical/thermal indices). It includes analysis packages to aid diagnosis. The device is used for guidance of procedures like biopsies and monitoring of follicle development. It benefits patients by providing non-invasive diagnostic imaging and fluid flow analysis across a wide range of clinical applications.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection validation, and thermal/electromagnetic/mechanical safety testing in accordance with IEC 60601-1, IEC 60601-2-37, and ISO 10993-1 standards.

Technological Characteristics

Mobile cart-based ultrasound system; 192 transmit/receive channels; 23/23.8-inch LCD monitor; 1.0-20.0 MHz frequency range. Modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Elastoscan, Tissue Harmonic Imaging. Biocompatibility per ISO 10993-1. Electrical safety per ANSI AAMI ES60601-1. EMC per IEC 60601-1-2. Acoustic output per NEMA UD-2/UD-3 and IEC 60601-2-37.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal, gynecology, intraoperative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac (adult/pediatric/trans-esophageal), and peripheral vessel 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

RS85 Diagnostic Ultrasound System (K191115)

Related Devices

K182932 — RS85 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Feb 15, 2019
K191115 — RS85 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jun 12, 2019
K151663 — RS80A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Aug 12, 2015
K141620 — RS80A DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Jul 2, 2014
K162094 — RS80A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Aug 26, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ September 19, 2019 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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. Samsung Medison Co., Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA # Re: K192030 Trade/Device Name: RS80 EVO Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 14, 2019 Received: August 15, 2019 Dear Ji Yea Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K192030 Device Name RS80 EVO Diagnostic Ultrasound System #### Indications for Use (Describe) The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ # 510(k) No.: K192030 Device Name: RS80 EVO Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | P | P | | | | | | | Fetal Imaging & Other | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 3, 4, 7, 8, 9, 11, 14 | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14, 15 | | | Intra-operative (See Note 6) | P | P | P | | P | Note 1 | Notes 7, 9, 11 | | | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Notes 7, 9, 11 | | | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 8, 9, 11 | | | Adult Cephalic | P | P | P | P | P | Note 1 | Notes 7 | | | Trans-rectal | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | Trans-vaginal | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 14 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 14 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 12 | | Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7 | | | Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 4, 7 | | | Trans-esophageal (Cardiac) | P | P | P | P | P | Note 1 | Notes 4, 7 | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 14 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 14: S-Fusion {4}------------------------------------------------ 510(k) No.: K192030 #### Device Name: CA1-7A for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |----------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|--------------------------| | General | Specific | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | (Track I only) | (Tracks I & III) | | | | | | | | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2,4,7,8,9,11,14 | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14,15 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | Pediatric | P | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | P | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2,6,7,8,9,11,14 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 14: S-Fusion Note 15: S-Shearwave {5}------------------------------------------------ ### 510(k) No.: K192030 Device Name: CF4-9 for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 7, 8, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | Pediatric | P | P | P | | P | Note 1 | Notes 7, 8, 9, 11 | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | P | P | P | | P | Note 1 | Notes 7, 8, 9, 11 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral | Peripheral vessel | P | P | P | | P | Note 1 | Notes 8, 9, 11 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 14: S-Fusion Note 15: S-Shearwave {6}------------------------------------------------ 510(k) No.: K192030 ### Device Name: CA2-8A for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|-------------------------|--| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | Intra-luminal | | | | | | | | | | | Other (See Note 13) | | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | | Vessel | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PPI+PW, B+PY+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel - Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging - Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate - Note 14: S-Fusion Note 15: S-Shearwave {7}------------------------------------------------ ### 510(k) No.: K192030 Device Name: CA3-10A for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2, 3, 7, 8, 9, 11 | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | Pediatric | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral | Peripheral vessel | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 11 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate Note 14: S-Fusion Note 15: S-Shearwave {8}------------------------------------------------ ### 510(k) No.: K192030 Device Name: E3-12A for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |---------------------------|-------------------------------|--|---------------------------------------------------|---|-----|-----|-------------------|----------------------|----------------------|--| | General (Track I only) | Specific (Tracks I & III) | | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | | Ophthalmic | Ophthalmic | | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | | Abdominal (See Note 10) | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | | Intra-operative (See Note 6) | | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Trans-rectal | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | | Trans-vaginal | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | | Intra-luminal | | | | | | | | | | | | Other (See Note 13) | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | | Cardiac Adult | | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | | Other (spec.) | | | | | | | | | | | | | | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | | Other (spec.) | | | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 14: S-Fusion Note 2: Includes imaging for guidance of biopsy {9}------------------------------------------------ 510(k) No.: K192030 ### Device Name: L3-12A for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------------------|--| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | | | | | | | | | | Trans-vaginal | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | | Intra-luminal | | | | | | | | | | | Other (See Note 13) | | | | | | | | | | | Cardiac Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 14: S-Fusion Note 2: Includes imaging for guidance of biopsy {10}------------------------------------------------ #### 510(k) No.: K192030 #### Device Name: EA2-11B for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | | | Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 6, 7, 8, 9, 12 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | | | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication: P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+TD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel - Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging - Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate - Note 14: S-Fusion - Note 15: S-Shearwave {11}------------------------------------------------ ### 510(k) No.: K192030 Device Name: LA2-9A for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|---------------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12,15 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 14: S-Fusion {12}------------------------------------------------ ### 510(k) No.: K192030 Device Name: LA3-16A for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|----------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging & Other | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11, 12 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel - Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging - Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate - Note 14: S-Fusion Note 15: S-Shearwave {13}------------------------------------------------ #### 510(k) No.: K192030 Device Name: LA3-16AI for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | |---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | | | | | | | | | | Intra-operative (See Note 6) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | | | Intra-operative (Neuro.) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 7, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K191115; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+PD+PW, B+PPF+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 14: S-Fusion Note 15: S-Shearwave Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {14}------------------------------------------------ ### 510(k) No.: K192030 Device Name: LA4-18B for use with RS80 EVO Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic |…