HERA W10 Diagnostic Ultrasound System

K182595 · Samsung Medison Co., Ltd. · IYN · Dec 18, 2018 · Radiology

Device Facts

Record IDK182595
Device NameHERA W10 Diagnostic Ultrasound System
ApplicantSamsung Medison Co., Ltd.
Product CodeIYN · Radiology
Decision DateDec 18, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1550
Device ClassClass 2
AttributesPediatric

Intended Use

The 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

HERA W10 is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in multiple modes: B-mode, M-mode, PW/CW Doppler, Color Doppler, Tissue Doppler, Power Amplitude Doppler, 3D/4D imaging, and specialized modes like Elastoscan+, MV-Flow, and S-Harmonic. Used in clinical settings by healthcare professionals to visualize anatomical structures and analyze body fluids for diagnostic purposes. The system provides real-time acoustic output (mechanical/thermal indices) and includes analysis packages for measurements. Operators use the system to capture, review, and report studies. New features include MPI+, QuickPrep (transducer recognition), SonoSync (image transfer), LumiFlow, and ShadowHDR. The device aids clinical decision-making by providing diagnostic-quality images and quantitative data.

Clinical Evidence

No clinical data was required to support substantial equivalence. The device was evaluated through bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electromagnetic, and mechanical safety testing, all conforming to recognized standards.

Technological Characteristics

Mobile diagnostic ultrasound system. Materials evaluated for biocompatibility per ISO 10993-1. Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Elastoscan+, Tissue Harmonic Imaging. Connectivity: Digital image capture/reporting. Safety standards: IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-2-37, NEMA UD 2, NEMA UD 3. Software-controlled with transducer recognition (QuickPrep).

Indications for Use

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

Regulatory Classification

Identification

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

Predicate Devices

Reference Devices

Related Devices

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 18, 2018 Samsung Medison Co., Ltd. Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA Re: K182595 Trade/Device Name: HERA W10 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: November 23, 2018 Received: November 26, 2018 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 avare 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. {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Hole 2. Nils for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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) K182595 Device Name HERA W10 Diagnostic Ultrasound System #### Indications for Use (Describe) The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, 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) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### 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) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/1 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 sans-serif and bold, giving the logo a clean and modern look. The blue oval is slightly tilted, adding a dynamic element to the design. 510(k) No.: ## Device Name: HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | N | N | N | N | N | Note 1 | Notes 2, 3, 4, 7, 8, 9, 11, 14 | | | | | Abdominal (See Note 10) | N | N | N | N | N | Note 1 | Notes 2, 4, 5, 6, 7, 8, 9, 11, 12, 14 | | | | | Intra-operative (See Note 6) | | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | | | Pediatric | N | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 11 | | | | | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | | | Neonatal Cephalic | N | N | N | N | N | Note 1 | Notes 8, 9, 11 | | | | | Adult Cephalic | N | N | N | N | N | Note 1 | Notes 7 | | | | | Trans-rectal | N | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | | | Trans-vaginal | N | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | | | Trans-urethral | | | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | | | Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | | | Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | | | Intra-luminal | | | | | | | | | | | | Other (See Note 13) | N | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 12 | | | | | Cardiac Adult | N | N | N | N | N | Note 1 | Notes 4, 7 | | | | Cardiac | Cardiac Pediatric | N | N | N | N | N | Note 1 | Notes 4, 7 | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | | Other (spec.) | | | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Notes 2, 5, 6, 7, 8, 9, 11, 14 | | | | | 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+DPI, B+PPI, B+CW, B+C+PW, B+PD+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, 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 {4}------------------------------------------------ Image /page/4/Picture/1 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 sans-serif and appears to be bolded. 510(k) No.: ### Device Name: L3-12A for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | N | N | N | | N | Note 1 | Note 2, 5, 6, 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 | | | | | | | | | | 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, 14 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>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 K173204, K173513; 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+CW, B+CW, B+C+PW, B+PD+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: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate {5}------------------------------------------------ Image /page/5/Picture/0 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 sans-serif and bold, and the letters are evenly spaced. 510(k) No.: Device Name: LA2-9A for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(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 | Laparoscopic | | | | | | | | | &<br>Other | Pediatric | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 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 1 | Note 2, 5, 6, 7, 8, 9, 11,12 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11,12 | | | 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 2, 5, 6, 7, 8, 9, 11 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K173204, K173513; 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+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+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: 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 Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {6}------------------------------------------------ Image /page/6/Picture/1 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 sans-serif and bold, and the oval is tilted slightly to the right. 510(k) No.: ### Device Name: LA4-18B for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | P | 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 2,5,6,7,8,9,11,12,14 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2,5,6,7,8,9,11,12,14 | | | 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, 5, 6, 7, 8, 9, 11, 14 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K173204, K173513; 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+DD+PW, B+DPD+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, 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 {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue background. The background is an oval shape with rounded corners. 510(k) No.: ### Device Name: CA1-7A for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(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 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& 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<br>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 K173204, K173513; 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+DD+PW, B+DPD+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, 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 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue background. The background is an oval shape with rounded corners. 510(k) No.: ### Device Name: CA2-9A for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal Imaging<br>& Other | 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 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | | 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 | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K173513; E= added under Appendix 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+PD+PW, B+DPD+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, 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 {9}------------------------------------------------ Image /page/9/Picture/0 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 sans-serif and bold, and the letters are evenly spaced. 510(k) No.: Device Name: CA3-10A for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 3, 7, 8, 9, 11, 14 | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 14 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 14 | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | N | N | N | N | N | Note 1 | Notes 2, 7, 8, 9, 11, 14 | | | 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, 14 | | | Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 14 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 11, 14 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K173204, K173513; E= added under Appendix 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+ID, B+CV, B+C+PW, B+PD+PW, B+PPH+N, B+PPH+N, B+ID+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 Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue background. The background is an oval shape with rounded corners. 510(k) No.: ### Device Name: CF4-9 for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 7, 8, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging<br>& 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<br>Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 8, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K173204, K173513; 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+DPD+PW, B+PPI+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, 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 {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue background. The background is an oval shape with rounded corners. 510(k) No.: ### Device Name: E3-12A for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(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<br>& 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, 14 | | | 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, 14 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K173204, K173513; 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+PPI+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 biopsv 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 {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue background. The background is an oval shape with rounded corners. 510(k) No.: ### Device Name: EA2-11B for use with HERA W10 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<br>Doppler* | Combined*<br>(Spec.) | Other<br>(Spec.) | | | (Track I only) | (Tracks I & III) | | | | | | | | | | 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<br>& 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, 14 | | | | 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, 14 | | | | Cardiac Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K173204, K173513; 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+DPD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 2: Includes imaging for guidance of biopsy {13}------------------------------------------------ Image /page/13/Picture/1 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 sans-serif and bold, and the letters are evenly spaced. The blue oval is slightly tilted. 510(k) No.: ### Device Name: VR5-9 for use with HERA W10 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler* | Combined*<br>(Spec.) | Other<br>(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<br>& 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 | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | |…
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