Who is the manufacturer of HM70A Diagnostic Ultrasound System?

Samsung Medison Co., Ltd. filed the 510(k) submission for HM70A Diagnostic Ultrasound System (K153408).

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?

UGEO H70c Diagnostic Ultrasound System (K130803); RS80A Diagnostic Ultrasound System (K151663); EKO7 Diagnostic Ultrasound System (K101455); ACCUVIX XG Diagnostic Ultrasound System (K103397).

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

K153408 · Samsung Medison Co., Ltd. · IYN · Dec 21, 2015 · Radiology

Device Facts

Record ID	K153408
Device Name	HM70A Diagnostic Ultrasound System
Applicant	Samsung Medison Co., Ltd.
Product Code	IYN · Radiology
Decision Date	Dec 21, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

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, 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.

Device Story

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, Spectral Doppler, Harmonic imaging, 3D/4D, and Elastoscan. Used in clinical settings by healthcare professionals for anatomical measurement and diagnostic analysis. The system provides real-time acoustic output display (mechanical/thermal indices). It supports advanced features like Stress Echo, Strain, and Needle Mate (biopsy guidance). Output is displayed on-screen for clinician interpretation to aid in diagnosis and clinical decision-making. Benefits include portable diagnostic imaging and fluid flow analysis.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements (NEMA UD-2, UD-3), biocompatibility (ISO 10993-1), and electrical/electromagnetic safety (IEC 60601 series).

Technological Characteristics

Hand-held ultrasound system; supports linear, curved, endocavity, phased array, and static probes (1.0–20.0 MHz). Energy source: ultrasonic. Connectivity: DICOM, Wireless LAN. Software-controlled with features like MultiVision (spatial compounding) and ClearVision (noise reduction). Biocompatibility per ISO 10993-1. Safety compliance: IEC 60601-1, IEC 60601-2-37.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid analysis of the human body in fetal/obstetrics, abdominal, gynecology, intra-operative, small organ, neonatal/adult cephalic, trans-rectal, trans-esophageal, musculoskeletal, urology, cardiac, and peripheral vessel applications. Patient population includes adult, pediatric, and neonatal patients.

Regulatory Classification

Identification

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

Predicate Devices

UGEO H70c Diagnostic Ultrasound System (K130803)
RS80A Diagnostic Ultrasound System (K151663)
EKO7 Diagnostic Ultrasound System (K101455)
ACCUVIX XG Diagnostic Ultrasound System (K103397)

Related Devices

K182894 — HM70A Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jan 22, 2019
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
K210713 — HM70 EVO Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Jul 9, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a ribbon-like design representing the snakes. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 21, 2015 Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street. NW BUFFALO MN 55313 Re: K153408 Trade/Device Name: HM70A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 23, 2015 Received: November 25, 2015 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, **Robert Oclo** Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) # K153408 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) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) No.: Device Name: 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) | N | N | N | N | N | Note 1 | Notes 2, 4, 7, 8, 9, 11 | | | | Abdominal (See Note 12) | N | N | N | N | N | Note 1 | Notes 2, 4, 7, 8, 9, 10, 11 | | | | Intra-operative (See Note 6) | N | N | N | N | N | Note 1 | Note 7, 8, 9, 11 | | | | Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Note 7, 8, 9, 11 | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | | Pediatric | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 11 | | | | Small Organ (See Note 5) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 8, 9, 10, 11 | | | | Neonatal Cephalic | N | N | N | N | N | Note 1 | Note 2, 7, 8, 9 | | | | Adult Cephalic | N | N | N | N | N | Note 1 | Note 4, 7 | | | | Trans-rectal | N | N | N | N | N | Note 1 | Note 2, 7, 8, 9, 10, 11 | | | | Trans-vaginal | N | N | N | N | N | Note 1 | Note 2, 7, 8, 9, 10, 11 | | | | Trans-urethral | | | | | | | | | | | Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note 1 | Note 4, 7 | | | | Musculo-skel. (Convent.) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | | Musculo-skel. (Superfic.) | N | N | N | N | N | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | | Intra-luminal | | | | | | | | | | | Other (spec.) (See Note 13) | N | N | N | N | N | Note 1 | Note 2, 7, 8, 10, 11 | | | Cardiac | Cardiac Adult | N | N | N | N | N | Note 1 | Note 4, 7 | | | | Cardiac Pediatric | N | N | N | N | N | Note 1 | Note 4, 7 | | | | Trans-esophageal (Cardiac) | N | N | N | N | N | Note 1 | Note 4, 7 | | | | Other (spec.) | | | | | | | | | | Peripheral Vessel | Peripheral vessel | N | N | N | N | N | 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+C+PW, 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) 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 | Note 1 | Notes 4, 7, 8, 9 | | | Abdominal (See Note 12) | 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 | 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 K130803; E= added under Appendix E ### Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C, B+PD, B+C+PW, 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 {5}------------------------------------------------ 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 & Other | Laparoscopic | | | | | | | | | | | 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 Vessel | Peripheral vessel | | | | | | | | | | | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K130803; 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 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 Note 2: Includes imaging for guidance of biopsy {6}------------------------------------------------ ### 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 | Laparoscopic | | | | | | | | | | & Other | 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 Adult | | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | | Other (spec.) | | | | | | | | | | Peripheral | Peripheral vessel | P | P | P | P | P | Note 1 | Notes 2, 7, 8, 9 | | | Vessel | Other (spec.) | | | | | | | | | N= new indication; P= previously cleared by FDA K130803; 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+C+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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 Note 2: Includes imaging for guidance of biopsy {7}------------------------------------------------ ## 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) | N | N | N | N | N | Note 1 | Note 2, 7, 11 | | | Abdominal (See Note 12) | N | N | N | N | N | Note 1 | Note 2, 7, 10, 11 | | | 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 | 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) | N | N | N | N | N | Note 1 | Note 2, 7, 10, 11 | | | Cardiac Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K130803; 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 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 Note 2: Includes imaging for guidance of biopsy {8}------------------------------------------------ 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 & Other | Laparoscopic | | | | | | | | | | 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 Vessel | Peripheral vessel | P | P | P | | P | Note 1 | Note 2, 5, 6, 7, 9, 11 | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K130803; 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 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 Note 2: Includes imaging for guidance of biopsy {9}------------------------------------------------ ### 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 K130803; 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+C+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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 Note 2: Includes imaging for guidance of biopsy {10}------------------------------------------------ ### 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 K130803; 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 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 Note 2: Includes imaging for guidance of biopsy {11}------------------------------------------------ ### 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 K130803; 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+C+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 {12}------------------------------------------------ 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 Imaging & Other | 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.) | | | | | | | | | | 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 | Cardiac Adult | P | P | P | P | P | Note 1 | Note 4, 7 | | | 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 K130803; 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+C+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E 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 Note 2: Includes imaging for guidance of biopsy {13}------------------------------------------------ ### 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/Obstetrics (See Note 3) | P | P | P | P | P | Note 1 | Note 2, 7, 8 | | | Abdominal (See Note 12) | P | P | P | P | P | Note 1 | Note 2, 7, 8 | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | Fetal Imaging & Other | Laparoscopic | | | | | | | | | | Pediatric | P | 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 Adult | | | | | | | | | Cardiac | Cardiac Pediatric | | | | | | | | | | Trans-esophageal (Cardiac) | | | | | | | | | | Other (spec.) | | | | | | | | | Peripheral Vessel | Peripheral vessel | | | | | | | | | | Other (spec.) | | | | | | | | N= new indication; P= previously cleared by FDA K130803; 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 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 Note 2: Includes imaging for guidance of biopsy {14}------------------------------------------------ ### 510(k) No.: Device Name: CW2.0 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) | | | | | | | | | | Abdominal (See Note 12) | | | | | | | | | | Intra-operative (See Note 6) | | | | | | | | | | Intra-operative (Neuro.) | | | | | | | | | | Laparoscopic | | | | | | | | | | Pediatric | | | | | | | | | | Small Organ (See Note 5) | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | Adult Cephalic | | | | P | | | | | | Trans-rectal | | | | | | | | | | Trans-vaginal | | | | | | | | | | Trans-urethral | | | | | | | | | | Trans-esoph. (non-Cardiac) | | | | | | | | | | Musculo-skel. (Convent.) | | | | | | | | | | Musculo-skel. (Superfic.) | | | | | | | | | | Intra-luminal | | | | | | | | | | Other (spec.) (See Note 13) | | | | | | |…