Who is the manufacturer of HS50 / HS60 Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for HS50 / HS60 Diagnostic Ultrasound System (K170493).

What is the FDA product code for HS50 / HS60 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 HS50 / HS60 Diagnostic Ultrasound System?

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

Does HS50 / HS60 Diagnostic Ultrasound System use AI or machine learning?

Yes. HS50 / HS60 Diagnostic Ultrasound System (K170493) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for HS50 / HS60 Diagnostic Ultrasound System?

H60 Diagnostic Ultrasound System (K143264); RS80A Diagnostic Ultrasound System (K162094); WS80A Diagnostic Ultrasound System (K153529); HM70A Diagnostic Ultrasound System (K153408); HS70A Diagnostic Ultrasound System (K163691).

Who can help prepare an FDA 510(k) submission like HS50 / HS60 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 HS50 / HS60 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.

HS50 / HS60 Diagnostic Ultrasound System

K170493 · Samsung Medison Co., Ltd. · IYN · Mar 28, 2017 · Radiology

Device Facts

Record ID	K170493
Device Name	HS50 / HS60 Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Mar 28, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric, 3rd-Party Reviewed

Intended Use

The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

Device Story

The HS50/HS60 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers (linear, curved, endocavity, phased array) and displays it in multiple modes: B, M, Color M, Anatomical, Color/Power Doppler, PW/CW Spectral Doppler, TDI, TDW, ElastoScan, and 3D/4D/XI STIC. The system performs post-processing of echoes to generate images of anatomical structures and fluid flow. It provides measurement and analysis packages to assist clinicians in diagnosis. The system features real-time acoustic output display (mechanical and thermal indices). It is intended for use by healthcare professionals in clinical settings. Output is viewed on-screen to support clinical decision-making and diagnostic assessment. The device benefits patients by providing non-invasive diagnostic imaging and guidance for procedures like biopsies.

Clinical Evidence

Bench testing only. No clinical studies were required to support substantial equivalence. The device was evaluated for acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, conforming to standards including IEC 60601-1, IEC 60601-2-37, and ISO 10993-1.

Technological Characteristics

Mobile diagnostic ultrasound system; supports linear, curved, endocavity, and phased array transducers. Frequency range 1.0–20.0 MHz. Modes: B, M, Color/Power Doppler, PW/CW Spectral Doppler, TDI, 3D/4D. Patient contact materials tested to ISO 10993-1. Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Features include Quick Scan, ClearVision, MultiVision, Needle Mate+, Auto IMT+, ElastoScan, and 3D/4D imaging tools.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis of the human body, including fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac, and peripheral vessel applications 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

H60 Diagnostic Ultrasound System (K143264)
RS80A Diagnostic Ultrasound System (K162094)
WS80A Diagnostic Ultrasound System (K153529)
HM70A Diagnostic Ultrasound System (K153408)
HS70A Diagnostic Ultrasound System (K163691)

Related Devices

K181336 — HS50 / HS60 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Dec 4, 2018
K163691 — HS70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Feb 22, 2017
K143264 — H60 V2.00 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Dec 9, 2014
K152962 — HS70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Nov 2, 2015
K182632 — HS30 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jan 8, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three profiles facing to the right, with flowing lines above them. The design is simple and monochromatic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 28, 2017 Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313 Re: K170493 Trade/Device Name: HS50 / HS60 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 14, 2017 Received: March 15, 2017 Dear Mr. Job: 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 D'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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170493 Device Name HS50 / HS60 Diagnostic Ultrasound System ### Indications for Use (Describe) The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 510(k) No.: Device Name: HS50 / HS60 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) | N | N | N | | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | | | Abdominal (See Note 10) | N | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 11, 12, 16 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | | | Small Organ (See Note 5) | N | N | N | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12, 17 | | | Neonatal Cephalic | N | N | N | | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | | | Adult Cephalic | N | N | N | N | Note 15 | Note 1 | Note 2, 7, 8, 9, 11 | | | Trans-rectal | N | N | N | | Note 15 | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | Trans-vaginal | N | N | N | | Note 15 | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | N | N | N | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12, 17 | | | Musculo-skel. (Superfic.) | N | N | N | | Note 15 | Note 1 | Note 2, 7, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | N | N | N | | Note 15 | Note 1 | Notes 2, 7, 8, 9, 12, 17 | | | Cardiac Adult | N | N | N | N | Note 15 | Note 1 | Note 4, 7, 14, 17 | | Cardiac | Cardiac Pediatric | N | N | N | N | Note 15 | Note 1 | Note 4, 7, 14, 17 | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | N | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode - 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: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast - Note 17: Strain+ {4}------------------------------------------------ 510(k) No.: Device Name: LA3-14AD for use with HS50 / HS60 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 | Note 15 | Note 1 | Note 2, 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 | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 | | | Musculo-skel. (Superfic.) | P | P | P | P | Note 15 | Note 1 | Note 2, 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 | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) 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: Tissue Doppler Imaging (TDI) - Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast {5}------------------------------------------------ ### 510(k) No.: Device Name: LA2-9A for use with HS60 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 | | Note 15 | Note 1 | Note 2, 7, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 2, 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 | | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K162094; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) 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: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast {6}------------------------------------------------ 510(k) No.: Device Name: LA3-16AI for use with HS60 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 | 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 | | Note 15 | Note 1 | Note 7, 9, 11 | | | | | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | 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 | | Note 15 | Note 1 | Note 6, 7, 9, 11 | | | | Vessel | Other (spec.) | | | | | | | | | | N= new indication; P= previously cleared by FDA K162094; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) 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: Tissue Doppler Imaging (TDI) - Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast {7}------------------------------------------------ 510(k) No.: Device Name: LA4-18BD for use with HS60 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 | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12, 17 | | | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 2, 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 | | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K162094; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) 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: Tissue Doppler Imaging (TDI) - Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast {8}------------------------------------------------ 510(k) No.: Device Name: LA3-16A for use with HS50 / HS60 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 | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12, 17 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 11, 12, 17 | | | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Note 2, 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 | | Note 15 | Note 1 | Note 2, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K162094; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) 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: Tissue Doppler Imaging (TDI) - Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast {9}------------------------------------------------ 510(k) No.: Device Name: CA1-7AD for use with HS50 / HS60 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 | | Note 15 | Note 1 | Notes 2, 7, 9, 11 | | | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 11, 16 | | | 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.) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 11 | | | 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 K153408; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) 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: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast {10}------------------------------------------------ 510(k) No.: Device Name: CA2-9AD for use with HS50 / HS60 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 | | Note 15 | Note 1 | Notes 2, 7, 9, 11 | | | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | 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.) | | | | | | | | | | 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 K153529; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) 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: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast {11}------------------------------------------------ 510(k) No.: Device Name: CF4-9 for use with HS50 / HS60 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 | | Note 15 | Note 1 | Notes 9, 11 | | | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Notes 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | Note 15 | Note 1 | Notes 6, 9, 11 | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | P | P | P | | Note 15 | Note 1 | Notes 9, 11 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | Note 15 | Note 1 | Notes 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode - 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: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast - Note 17: Strain+ {12}------------------------------------------------ ### 510(k) No.: Device Name: ER4-9 for use with HS50 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 | | Note 15 | Note 1 | Notes 2, 7, 9 | | | Abdominal (See Note 10) | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 12 | | | Trans-vaginal | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 12 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | P | P | P | | Note 15 | Note 1 | Notes 2, 7, 9, 12 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K143264; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode - 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: Tissue Doppler Imaging (TDI) Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast - Note 17: Strain+ {13}------------------------------------------------ ### 510(k) No.: Device Name: EA2-11B for use with HS60 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 | | Note 15 | Note 1 | Note 2, 7, 9 | | | Abdominal (See Note 10) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 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 | | Note 15 | Note 1 | Note 2, 7, 9, 12 | | | Trans-vaginal | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 12 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | P | P | P | | Note 15 | Note 1 | Note 2, 7, 9, 12, 17 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E ### Additional Comments: Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+Elastosan, B+C+PW, B+DPD+PW, B+DPD+PW, B+C+M, B+C+CW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD) Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode - 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: Tissue Doppler Imaging (TDI) - Note 15: Color Doppler includes Power (Amplitude) Doppler - Note 16: Contrast - Note 17: Strain+ {14}------------------------------------------------ ### 510(k) No.: Device Name: PA1-5A for use with HS60 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) | | | | | | | | | Fetal Imaging & Other | Abdominal (See Note 10) | P | P | P | P | Note 15 | Note 1 | Note 7 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | P | P | P | P | Note 15 | Note 1 | Note 7 | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardi…