Who is the manufacturer of RS85 Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for RS85 Diagnostic Ultrasound System (K191115).

What is the FDA product code for RS85 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 RS85 Diagnostic Ultrasound System?

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

What are the predicate devices for RS85 Diagnostic Ultrasound System?

RS85 Diagnostic Ultrasound System (K182932).

Who can help prepare an FDA 510(k) submission like RS85 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.

RS85 Diagnostic Ultrasound System

K191115 · Samsung Medison Co., Ltd. · IYN · Jun 12, 2019 · Radiology

Device Facts

Record ID	K191115
Device Name	RS85 Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Jun 12, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: [Table of clinical applications and modes of operation provided for the system and various probes].

Device Story

The RS85 is a mobile, software-controlled diagnostic ultrasound system used by healthcare professionals in clinical settings. It acquires ultrasound data via various transducers (linear, curved, phased, endocavity, static) and displays it in multiple modes: 2D, Color/Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D, and Elastoscan. The system includes analysis packages for anatomical measurements to aid diagnosis. It features real-time acoustic output display (mechanical and thermal indices). Operators use the system to visualize internal structures and blood flow, facilitating clinical decision-making for various applications including obstetrics, cardiology, and musculoskeletal assessment. Benefits include non-invasive diagnostic imaging and guidance for procedures like biopsies.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, cleaning/disinfection, and thermal/electromagnetic/mechanical safety testing, alongside software verification and validation.

Technological Characteristics

Mobile ultrasound system with 192 transmit/receive channels. Supports various transducers (1.0-20.0 MHz). Features include B-mode, M-mode, PW/CW Doppler, Color/Power Doppler, Tissue Harmonic Imaging, 3D/4D, and Elastoscan. Connectivity includes WiFi. Biocompatibility per ISO 10993-1. Electrical safety per IEC 60601-1. Software-controlled functionality.

Indications for Use

Indicated for 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 imaging and fluid flow analysis in adult, pediatric, and neonatal patients.

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 (K182932)

Related Devices

K182932 — RS85 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Feb 15, 2019
K173204 — RS85 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Feb 5, 2018
K141620 — RS80A DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Jul 2, 2014
K192903 — RS85 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jan 6, 2020
K192030 — RS80 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Sep 19, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. SAMSUNG MEDISON CO., LTD. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA # Re: K191115 Trade/Device Name: RS85 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: May 17, 2019 Received: May 21, 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 June 12, 2019 {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) K191115 Device Name RS85 Diagnostic Ultrasound System #### Indications for Use (Describe) The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ 510(k) No.: Device Name: RS85 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 | | | | | | | | | | 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 | Note 7, 9, 11 | | | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Note 7, 9, 11 | | Fetal Imaging & Other | 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 | Note 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 | 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) | P | P | P | | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4, 7 | | Cardiac | 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 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182932; 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.: ## Device Name: CA1-7A for use with RS85 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 2,4,7,8,9,11,14 | | | Abdominal (See Note 10) | 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 & Other | Laparoscopic | | | | | | | | | | Pediatric | 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 | Note 1 | Notes 2,6,7,8,9,11,14 | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | 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 Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182932; 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 {5}------------------------------------------------ 510(k) No.: ### Device Name: CF4-9 for use with RS85 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) | | | | | | | | | | 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 & Other | Laparoscopic | | | | | | | | | | 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 K182932; 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 Note 15: S-Shearwave {6}------------------------------------------------ 510(k) No.: ## Device Name: CA2-8A for use with RS85 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 Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182932; 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.: ## Device Name: CA3-10A for use with RS85 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, 3, 7, 8, 9, 11 | | | Abdominal (See Note 10) | P | 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 | 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 | P | Note 1 | Notes 2, 7, 8, 9, 11 | | | Musculo-skel. (Superfic.) | P | 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 | P | Note 1 | Notes 2, 7, 8, 9, 11 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182932; 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+CV, B+C+PW, B+C+PW, B+DPD+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 Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {8}------------------------------------------------ 510(k) No.: ## Device Name: E3-12A for use with RS85 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 K182932; 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 15: S-Shearwave Note TSTB Shear Wave Note 2: Includes imaging for guidance of biopsy {9}------------------------------------------------ 510(k) No.: ## Device Name: L3-12A for use with RS85 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) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | 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 | Cardiac Adult | | | | | | | | | | 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 K182932; 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 {10}------------------------------------------------ ## 510(k) No.: ### Device Name: EA2-11B for use with RS85 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 Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182932; 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.: ### Device Name: LA2-9A for use with RS85 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 | Cardiac Adult | | | | | | | | | | 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 K182932; 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 {12}------------------------------------------------ 510(k) No.: ## Device Name: LA3-16A for use with RS85 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) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | 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 Adult | | | | | | | | | | Cardiac | 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 K182932; 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+CV, B+C+PW, B+C+PW, B+DPD+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 Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {13}------------------------------------------------ 510(k) No.: ## Device Name: LA3-16AI for use with RS85 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 | Note 1 | Note 7, 9, 11 | | | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Note 7, 9, 11 | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | 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 | Note 1 | Note 7, 9, 11 | | | Musculo-skel. (Superfic.) | 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 | Peripheral vessel | P | P | P | | P | Note 1 | Note 7, 9, 11 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182932; 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+CV, B+C+PW, B+C+PW, B+DPD+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 {14}------------------------------------------------ 510(k) No.: ## Device Name: LA4-18B for use with RS85 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) | | | | | | | |…