Who is the manufacturer of HS40 Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for HS40 Diagnostic Ultrasound System (K191055).

What is the FDA product code for HS40 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 HS40 Diagnostic Ultrasound System?

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

What are the predicate devices for HS40 Diagnostic Ultrasound System?

HS40 Diagnostic Ultrasound System (K180409); HS50/60 Diagnostic Ultrasound System (K181336); SONOACE R7 Diagnostic Ultrasound System (K133505); HM70A Diagnostic Ultrasound System (K182894).

Who can help prepare an FDA 510(k) submission like HS40 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.

HS40 Diagnostic Ultrasound System

K191055 · Samsung Medison Co., Ltd. · IYN · Jun 12, 2019 · Radiology

Device Facts

Record ID	K191055
Device Name	HS40 Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Jun 12, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The HS40 ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. 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 HS40 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in multiple modes: 2D, M-mode, Color/Power/Directional Power Doppler, PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, Panoramic, Freehand 3D, and real-time 4D. The system includes analysis packages for anatomical measurements to assist clinicians in diagnosis. It is intended for use by healthcare professionals in clinical settings. The device displays real-time mechanical and thermal acoustic output indices. It incorporates software features such as 2DNT, BiometryAssist, E-Strain, NeedleMate, and AutoIMT. The system aids clinical decision-making by providing visual images and quantitative data for patient assessment.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on non-clinical bench testing, including acoustic output, biocompatibility, software verification/validation, and thermal/electrical/EMC safety testing in compliance with FDA-recognized standards (e.g., IEC 60601-1, ISO 10993-1, NEMA UD 2/3).

Technological Characteristics

Mobile ultrasound system; supports 2D, M-mode, Doppler (Color, Power, PW, CW), Harmonic, Tissue Doppler, 3D/4D, and Elastoscan. Connectivity includes digital image capture and reporting. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound safety), and NEMA UD 2/3 (acoustic output). Materials evaluated for biocompatibility per ISO 10993-1.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal, gynecology, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, urology, cardiac, and peripheral vessel applications. Prescription use only.

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

HS40 Diagnostic Ultrasound System (K180409)
HS50/60 Diagnostic Ultrasound System (K181336)
SONOACE R7 Diagnostic Ultrasound System (K133505)
HM70A Diagnostic Ultrasound System (K182894)

Related Devices

K180409 — HS40 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · May 11, 2018
K200339 — HS40 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Apr 7, 2020
K210426 — HS40 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · May 13, 2021
K172129 — HS40 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Aug 8, 2017
K202556 — HS30 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Oct 30, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Samsung Medison Co., Ltd. % Scully Kim Regulatory Affairs Specialist 3366. Hanseo-ro. Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA June 12, 2019 Re: K191055 Trade/Device Name: HS40 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: April 17, 2019 Received: April 19, 2019 Dear Scully Kim: 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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 Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number K191055 Device Name HS40 Diagnostic Ultrasound System #### Indications for Use (Describe) The HS40 ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. 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. 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." {3}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/3/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is set against a blue, oval-shaped background. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT ## 510(k) No.: K191055 Device Name: HS40 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 | Note 2, 7, 8, 9, 11 | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11 | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11, 12 | | | Neonatal Cephalic | P | P | P | | P | Note 1 | Note 8, 9, 11 | | | Adult Cephalic | P | P | P | P | P | Note 1 | Note 7 | | | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | | | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 11, 12 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 7, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | P | P | P | | P | Note 1 | Note 2, 7, 9, 12 | | | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7, 14 | | Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7, 14 | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA; 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+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for quidance 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) {4}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/4/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is set against a blue, oval-shaped background, which is tilted slightly. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: ### Device Name: LA3-16AD for use with HS40 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, 7, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | P | P | Note 1 | Note 2, 7, 9, 11 | | | Small Organ (See Note 5) | P | P | P | P | P | 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 | P | Note 1 | Note 2, 7, 9, 11, 12 | | | Musculo-skel. (Superfic.) | P | P | P | P | P | 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 | P | Note 1 | Note 2, 5, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K180409 ; E= added under Appendix E #### Additional Comments: Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PPI, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, 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) Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {5}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/5/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: CA2-8AD for use with HS40 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, 9, 11 | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | P | P | Note 1 | Note 2, 7, 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 | Note 2, 7, 9, 11 | | | 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 | P | Note 1 | Note 2, 7, 9, 11 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K180409; 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+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for quidance 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) {6}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/6/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: CF4-9 for use with HS40 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 7, 8, 9, 11 | | | | Abdominal (See Note 10) | P | 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 | P | Note 1 | Notes 7, 8, 9, 11 | | | | Small Organ (See Note 5) | | | | | | | | | | | Neonatal Cephalic | P | 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.) | P | P | P | P | P | Note 1 | Notes 7, 8, 9, 11 | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | 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 | Notes 7, 8, 9, 11 | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K180409; 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+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for quidance 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) {7}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/7/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: PN2-4 for use with HS40 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 7 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | P | P | P | | P | Note 1 | Note 7 | | | | Trans-rectal (See Note 13) | | | | | | | | | | | Trans-vaginal (See Note 13) | | | | | | | | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | Intra-luminal | | | | | | | | | | | Other (See Note 13) | | | | | | | | | | | Cardiac Adult | P | P | P | | P | Note 1 | Note 4, 7, 14 | | | Cardiac | Cardiac Pediatric | P | P | P | | P | Note 1 | Note 4, 7, 14 | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E #### Additional Comments: Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PPI, B+TD, B+PPI+PW, 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) Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {8}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/8/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside of a blue, oval shape. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: EVN4-9 for use with HS40 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 | Note 2, 7, 9 | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 7, 9 | | | 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 | Note 1 | Note 2, 7, 9, 12 | | | Trans-vaginal | P | P | P | | P | Note 1 | Note 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 | | P | Note 1 | Note 2, 7, 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 K180409; E= added under Appendix E #### Additional Comments: Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PPI, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, 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) Image /page/8/Figure/24 description: The image contains text that indicates concurrence of the Center for Devices and Radiological Health (CDRH). It also mentions "Prescription Use" and references "Per 21 CFR 801.109". The text is centered and presented in a straightforward manner. {9}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/9/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is bold and sans-serif, and the letters are evenly spaced. The blue oval is slightly tilted, giving the logo a dynamic appearance. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: VN4-8 for use with HS40 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, 11 | | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 11 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | P | P | P | P | P | Note 1 | Note 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.) | | | | | | | | | | | 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 K180409; E= added under Appendix E #### Additional Comments: Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, B+C+CW, B+PPI, B+TD, B+PPI+PW, 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) {10}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/10/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is set against a blue, oval-shaped background. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: ### Device Name: V5-9 for use with HS40 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) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9 | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 12 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 12 | | | Trans-vaginal | 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 | 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 K180409; 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+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for quidance 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) {11}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/11/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: ### Device Name: DP2B for use with HS40 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 12) | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | P | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | Cardiac | Cardiac Adult | | | | P | | | | | | Cardiac Pediatric | | | | P | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | P | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K180409; 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+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for quidance 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) {12}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/12/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is tilted slightly upwards. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: C2-8 for use with HS40 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) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2, 6, 7, 8, 9, 11 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | | Laparoscopic | | | | | | | | | | | 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.) | | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | Intra-luminal | | | | | | | | | | | Other (See Note 13) | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K180409; 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+TD, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for quidance 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) {13}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/13/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is tilted slightly upwards. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: C2-5 for use with HS40 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, 6, 7, 8, 9, 11 | | | | | Intra-operative (See Note 6) | | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | | 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.) | | | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | | Intra-luminal | | | | | | | | | | | | Other (See Note 13) | | | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | | Other (spec.) | | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | | Other (spec.) | | | | | | | | | | N= new indication; P= previously cleared by FDA K180409; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+P…