Who is the manufacturer of HERA I10 Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for HERA I10 Diagnostic Ultrasound System (K190444).

What is the FDA product code for HERA I10 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 HERA I10 Diagnostic Ultrasound System?

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

Does HERA I10 Diagnostic Ultrasound System use AI or machine learning?

Yes. HERA I10 Diagnostic Ultrasound System (K190444) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for HERA I10 Diagnostic Ultrasound System?

HERA W10 Diagnostic Ultrasound System (K182595).

Who can help prepare an FDA 510(k) submission like HERA I10 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 HERA I10 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.

HERA I10 Diagnostic Ultrasound System

K190444 · Samsung Medison Co., Ltd. · IYN · May 22, 2019 · Radiology

Device Facts

Record ID	K190444
Device Name	HERA I10 Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	May 22, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/Obstetrics, Abdominal, Gynecology, 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 I10 is a mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via various transducers; displays data in B-mode, M-mode, PW/CW Doppler, Color Doppler, TDI, TDW, Power Amplitude Doppler, S-Harmonic, S-Flow, Color M-Mode, 3D/4D imaging, Elastoscan+, and MV-Flow. Used in clinical settings by physicians/sonographers for anatomical measurement and diagnosis. System provides real-time acoustic output display (mechanical/thermal indices). Operators use system output to inform clinical decision-making for patient diagnosis. Benefits include non-invasive visualization of internal structures and fluid flow.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including acoustic output, biocompatibility, electrical/electromagnetic safety, and software validation.

Technological Characteristics

Mobile cart-based ultrasound system; 192 transmit/receive channels; LCD monitor with LED backlight; 256 gray shades. Transducers: Linear, Curved Linear, Endocavity, Phased Array (1.0-20.0 MHz). Connectivity: Digital storage/transfer, WLAN. Safety: IEC 60601-1, IEC 60601-1-2, ISO 10993-1. Software-controlled imaging modes including 3D/4D, Elastoscan+, and various automated analysis packages.

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. For use by competent healthcare professionals.

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

HERA W10 Diagnostic Ultrasound System (K182595)

Related Devices

K182595 — HERA W10 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Dec 18, 2018
K221117 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jun 17, 2022
K112646 — SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM · Samsung Medison Co., Ltd. · Oct 12, 2011
K192319 — HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Dec 10, 2019
K040060 — SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS · Siemens Medical Solutions USA, Inc. · Jan 28, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol is a stylized depiction of a human figure. To the right of the symbol is a blue square containing the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. Samsung Medison Co., Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA May 22, 2019 # Re: K190444 Trade/Device Name: HERA I10 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: February 21, 2018 Received: February 25, 2019 Dear Ji Yea Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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, 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K190444 Device Name HERA 110 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, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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}------------------------------------------------ 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 oval is tilted slightly, giving the logo a dynamic appearance. 510(k) No.: # Device Name: HERA 110 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 | | 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 & 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 | Note 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 | Note 1 | Notes 2, 7, 8, 9, 11, 12 | | | Trans-vaginal | 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 | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | Musculo-skel. (Superfic.) | N | N | N | | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 12, 14 | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | 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 Vessel | Peripheral vessel | N | N | N | N | N | Note 1 | Note 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+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate {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 bold, and the oval is tilted slightly upward from left to right. 510(k) No.: ### Device Name: L3-12A for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------------------|--| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | 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 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 K182595; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 2: Includes imaging for guidance of biopsy {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-shaped background. The font is sans-serif and appears to be bolded. 510(k) No.: Device Name: LA2-9A for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|------------------------------|--| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | 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 Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | | Other (spec.) | | | | | | | | | N= new indication: P= previously cleared by FDA K182595; 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 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 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is tilted slightly to the right. The background is a rounded parallelogram shape. 510(k) No.: ### Device Name: LA4-18B for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |-----------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | | | | | | | | | Abdominal (See Note 10) | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 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 | P | Note 1 | Note 2,5,6,7,8,9,11,12,14 | | | Musculo-skel. (Superfic.) | P | 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 Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 8, 9, 11, 14 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+C+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel - Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate Note 14: S-Fusion {7}------------------------------------------------ Image /page/7/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 oval is tilted slightly, giving the logo a dynamic appearance. 510(k) No.: ### Device Name: CA1-7A for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | | P | Note 1 | Notes 2,4,7,8,9,11,14 | | | Abdominal (See Note 10) | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Notes 2,6,7,8,9,11,14 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+TD, B+C+PW, B+C+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel - Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate Note 14: S-Fusion - Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written 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 I10 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 | 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 Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182595; 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+TD, B+C+PW, B+C+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel - Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging - Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate - Note 14: S-Fusion {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 appears to be bolded. #### 510(k) No.: Device Name: CA3-10A for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|----------------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 3, 7, 8, 9, 11,14 | | | 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 & 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 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 K182595; 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+TD, B+CW, B+C+PW, B+C+PW, B+PD+PW, B+PPH+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy - Note 3: Includes infertility monitoring of follicle development - Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients - Note 6: Abdominal organs and peripheral vessel - Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging - Note 9: MultiVision (Spatial Compound Imaging) - Note 10: Includes Renal, Gynecology/Pelvis - Note 11: Panoramic imaging - Note 12: ElastoScan - Note 13: Includes Urology/Prostate - Note 14: S-Fusion {10}------------------------------------------------ Image /page/10/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 oval is tilted slightly, giving the logo a dynamic appearance. 510(k) No.: ### Device Name: CF4-9 for use with HERA I10 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 | 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.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 8, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C - Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) - Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance. 510(k) No.: ### Device Name: E3-12A for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | | | |---------------------------|-------------------------------|---|---------------------------------------------------|-----|-----|-------------------|----------------------|--------------------------|--|--|--| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | | | | Ophthalmic | Ophthalmic | | | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | | | | Intra-operative (See Note 6) | | | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | | | | & Other | 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 | Peripheral vessel | | | | | | | | | | | | Vessel | Other (spec.) | | | | | | | | | | | N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 2: Includes imaging for guidance of biopsy {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The font is sans-serif and bold, and the logo is clean and modern. 510(k) No.: ### Device Name: EA2-11B for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|--|---------------------------------------------------|---|-----|-----|-------------------|----------------------|--------------------------| | General (Track I only) | Specific (Tracks I & III) | | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | | Fetal/Obstetrics (See Note 3) | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | Abdominal (See Note 10) | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12, 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 | Cardiac Adult | | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K182595; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+PPL, B+CW, B+CW, B+C+PW, B+PD+PW, B+PPH+PW, B+PPH+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E, B+B/C Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: Spatial Compound Imaging Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging Note 12: ElastoScan Note 13: Includes Urology/Prostate Note 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 oval is tilted slightly, giving the logo a dynamic appearance. 510(k) No.: ### Device Name: VR5-9 for use with HERA I10 Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | | Mode of Operation (*includes simultaneous B-mode) | | | | | | | |---------------------------|-------------------------------|---------------------------------------------------|---|-----|-----|-------------------|----------------------|-----------------------| | General (Track I only) | Specific (Tracks I & III) | B | M | PWD | CWD | Color Doppler* | Combined* (Spec.) | Other (Spec.) | | Ophthalmic | Ophthalmic | | | | | | | | | | Fetal/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | Abdominal (See Note 10) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12 | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (See Note 13) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9, 12, | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | |…