Who is the manufacturer of HM70A Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for HM70A Diagnostic Ultrasound System (K182894).

What is the FDA product code for HM70A 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 HM70A Diagnostic Ultrasound System?

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

What are the predicate devices for HM70A Diagnostic Ultrasound System?

HM70A Diagnostic Ultrasound System (K153408); UGEO PT60A Diagnostic Ultrasound System (K142466); HS50/60 Diagnostic Ultrasound System (K170493); eZono 4000 (K140254).

Who can help prepare an FDA 510(k) submission like HM70A 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.

HM70A Diagnostic Ultrasound System

K182894 · Samsung Medison Co., Ltd. · IYN · Jan 22, 2019 · Radiology

Device Facts

Record ID	K182894
Device Name	HM70A Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Jan 22, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The HM70A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.

Device Story

The HM70A is a hand-held, software-controlled diagnostic ultrasound system. It acquires ultrasound data via various transducers and displays it in modes including 2D, M-mode, Color/Power Doppler (including S-Flow), PW/CW Spectral Doppler, Harmonic imaging, Tissue Doppler, 3D/4D, and Elastoscan. Used in clinical settings by healthcare professionals, the device allows for anatomical measurements and analysis packages to support diagnosis. It provides real-time acoustic output display (mechanical and thermal indices). The system aids clinicians in visualizing internal structures and fluid flow, facilitating diagnostic decision-making.

Clinical Evidence

No clinical studies were required to support substantial equivalence. The device relies on bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection validation, and thermal/electromagnetic/mechanical safety testing, all conforming to applicable standards (e.g., IEC 60601-1, IEC 60601-2-37, NEMA UD 2/3).

Technological Characteristics

Hand-held, software-controlled ultrasound system. Features 128-channel architecture. Supports multiple imaging modes (2D, M, Doppler, 3D/4D, Elastoscan). Connectivity includes digital image capture and reporting. Safety standards: ANSI AAMI ES60601-1, IEC 60601-1-2 (4th Ed), IEC 60601-2-37. Acoustic output: NEMA UD 2/3. Biocompatibility: Evaluated per ISO 10993.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis of the human body in patients including fetal/obstetrics, abdominal, gynecological, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-esophageal, musculoskeletal, urological, cardiac, 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

HM70A Diagnostic Ultrasound System (K153408)
UGEO PT60A Diagnostic Ultrasound System (K142466)
HS50/60 Diagnostic Ultrasound System (K170493)
eZono 4000 (K140254)

Related Devices

K153408 — HM70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Dec 21, 2015
K152962 — HS70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Nov 2, 2015
K173713 — HS70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Mar 8, 2018
K200699 — HS70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · May 7, 2020
K220269 — HM70 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · May 6, 2022

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. Samsung Medison Co., Ltd. Scully Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, 25108 REPUBLIC OF KOREA Re: K182894 Trade/Device Name: HM70A Diagnostic Ultrasound System LS3-14B Transducer Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 12, 2018 Received: December 28, 2018 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. January 22, 2019 {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.html; 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 mediation-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, Michael D. O'Hara 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) ### K182894 Device Name HM70A Diagnostic Ultrasound System #### Indications for Use (Describe) The HM70A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-esophageal (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), 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) 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." {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, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: HM70A 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 | P | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | | | Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Notes 2, 4, 7, 8, 9, 10, 11 | | | | Intra-operative (See Note 6) | P | P | P | | P | Note 1 | Note 7, 8, 9, 11 | | | | Intra-operative (Neuro.) | P | P | P | | P | Note 1 | Note 7, 8, 9, 11 | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | P | P | P | | P | 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, 10, 11 | | | | Neonatal Cephalic | P | P | P | | P | Note 1 | Note 2, 7, 8, 9 | | | | Adult Cephalic | P | P | P | P | P | Note 1 | Note 4, 7 | | | | Trans-rectal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 10, 11 | | | | Trans-vaginal | P | P | P | | P | Note 1 | Note 2, 7, 8, 9, 10, 11 | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Cardiac) | P | P | P | P | P | Note 1 | Note 4, 7 | | | | Musculo-skel. (Convent.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | | Intra-luminal | | | | | | | | | | | Other (spec.) (See Note 13) | P | P | P | | P | Note 1 | Note 2, 7, 8, 10, 11 | | | | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | | | Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | | | | Trans-esophageal (Cardiac) | P | P | P | P | P | Note 1 | Note 4, 7 | | | | Other (spec.) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 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+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging Note10: ElastoScan Note11: MultiVision (old name: Spatial Compound Imaging) Note12: Includes Renal, Gynecology/Pelvis Note13: Includes Urology/Prostate {4}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/4/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is placed inside a blue, oval-shaped background. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: SC1-6 for use with HM70A 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 4, 7, 8, 9 | | | Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Notes 7, 8, 9 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | P | P | P | P | P | Note 1 | Notes 7, 8, 9 | | | 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 (spec.) (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging Note10: ElastoScan Note11: MultiVision (old name: Spatial Compound Imaging) Note12: Includes Renal, Gynecology/Pelvis Note13: Includes Urology/Prostate {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 letters on a blue oval background. The oval is tilted slightly to the right. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: C2-6 for use with HM70A 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 | | | Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | Pediatric | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | 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 (spec.) (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: - Color Doppler includes Power (Amplitude) Doppler - Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging - Note10: ElastoScan - Note11: MultiVision (old name: Spatial Compound Imaging) - Note12: Includes Renal, Gynecology/Pelvis - Note13: Includes Urology/Prostate Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {6}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/6/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: CF4-9 for use with HM70A 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 12) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | 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 | | | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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 9: Panoramic imaging Note10: ElastoScan Note11: MultiVision (old name: Spatial Compound Imaging) Note12: Includes Renal, Gynecology/Pelvis Note13: Includes Urology/Prostate Note 8: 3D imaging {7}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/7/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT ### 510(k) No.: Device Name: EVN4-9 for use with HM70A 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, 11 | | | | Abdominal (See Note 12) | P | P | P | | P | Note 1 | Note 2, 7, 10, 11 | | | | Intra-operative (See Note 6) | | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | | & Other | Pediatric | | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | Trans-rectal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10, 11 | | | | Trans-vaginal | P | P | P | P | P | Note 1 | Note 2, 7, 8, 9, 10, 11 | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | | Intra-luminal | | | | | | | | | | | Other (spec.) (See Note 13) | P | P | P | P | P | Note 1 | Note 2, 7, 10, 11 | | | | Cardiac Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral | Peripheral vessel | | | | | | | | | | Vessel | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: - Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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 9: Panoramic imaging Note10: ElastoScan Note11: MultiVision (old name: Spatial Compound Imaging) Note12: Includes Renal, Gynecology/Pelvis Note13: Includes Urology/Prostate Note 8: 3D imaging {8}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/8/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: L4-7 for use with HM70A 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) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging | Laparoscopic | | | | | | | | | & Other | Pediatric | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Small Organ (See Note 5) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | 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, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (spec.) (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, 9, 11 | | Vessel | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: - Color Doppler includes Power (Amplitude) Doppler - Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging - Note10: ElastoScan - Note11: MultiVision (old name: Spatial Compound Imaging) - Note12: Includes Renal, Gynecology/Pelvis - Note13: Includes Urology/Prostate Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {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 letters on a blue oval background. The oval is tilted slightly to the right. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: L5-13 for use with HM70A 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 | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 10, 11 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging Note10: ElastoScan Note11: MultiVision (old name: Spatial Compound Imaging) Note12: Includes Renal, Gynecology/Pelvis Note13: Includes Urology/Prostate {10}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/10/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: L7-16 for use with HM70A 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 | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | | | | | | | | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | P | P | P | P | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging - Note10: ElastoScan - Note11: MultiVision (old name: Spatial Compound Imaging) - Note12: Includes Renal, Gynecology/Pelvis - Note13: Includes Urology/Prostate Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) {11}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/11/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right. ### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: PE2-4 for use with HM70A 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) | P | P | P | P | P | Note 1 | Note 4, 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 | P | Note 1 | Note 4, 7 | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | | | | | | | | | | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | | Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: - Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging Note10: ElastoScan Note11: MultiVision (old name: Spatial Compound Imaging) Note12: Includes Renal, Gynecology/Pelvis Note13: Includes Urology/Prostate {12}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/12/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: P3-8 for use with HM70A 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) | P | P | P | P | P | Note 1 | Note 4, 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 | P | Note 1 | Note 4, 7 | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | | | | | | | | | | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | | Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1 | Note 4, 7 | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K153408; E= added under Appendix E #### Additional Comments: - Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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: Panoramic imaging Note10: ElastoScan Note11: MultiVision (old name: Spatial Compound Imaging) Note12: Includes Renal, Gynecology/Pelvis Note13: Includes Urology/Prostate {13}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/13/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right. ## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT 510(k) No.: Device Name: VN4-8 for use with HM70A 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 | Note 2, 7, 8 | | | Abdominal (See Note 12) | P | P | P | | P | Note 1 | Note 2, 7, 8 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | & Other | Pediatric | P | P | P | | P | Note 1 | Note 2, 7, 8 | | | 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 (spec.) (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 K153408; E= added under Appendix E #### Additional Comments: - Color Doppler includes Power (Amplitude) Doppler - Note 1: B+M, B+PW, B+C, B+PD, B+CW, B+C+PW, B+PD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E - 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: Panoramic imaging - Note10: ElastoScan - Note11: MultiVision (old name: Spatial Compound Imaging) - Note12: Includes Renal, Gynecology/Pelvis - Note13: Includes Urology/Prostate {14}------------------------------------------------ 510(k) Premarket Notification - Traditional Image /page/14/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right. ## DIAGNOSTIC ULTRASOUND INDICATI…