K Number
K163691
Device Name
HS70A Diagnostic Ultrasound System
Date Cleared
2017-02-22

(56 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HS70A 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-reginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
Device Description
The HS70A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
More Information

Not Found

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and analysis packages, with no mention of AI/ML features.

No
The device is described as a "Diagnostic Ultrasound System" for "diagnostic ultrasound imaging and fluid analysis of the human body," not for treatment.

Yes
The "Intended Use / Indications for Use" section explicitly states, "The HS70A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" calls it a "diagnostic ultrasound system" and notes it "offers analysis packages that provide information that is used to make a diagnosis."

No

The device description explicitly states it is a "diagnostic ultrasound system" and mentions acquiring ultrasound data and displaying it. This indicates the presence of hardware components (transducers, processing unit, display) beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Function: The HS70A Diagnostic Ultrasound System is used for imaging the human body directly using ultrasound waves. It does not analyze samples taken from the body.
  • Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body," which refers to imaging fluids within the body, not analyzing fluids removed from the body.
  • Device Description: The description focuses on acquiring and displaying ultrasound data as various imaging modes.

Therefore, the HS70A is a diagnostic imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The HS70A 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-reginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The HS70A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ (thyroid, parathyroid, breast, scrotum and penis), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology (Includes Renal, Gynecology/Pelvis, Prostate), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.

Indicated Patient Age Range

Adult, pediatric, and neonatal patients.

Intended User / Care Setting

Competent health care professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards. The subject device did not require clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152962, K153529, K162094, K153539, K141620, K150478, K142160, K161047

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a wing-like shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2017

SAMSUNG MEDISON CO., LTD. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K163691

Trade/Device Name: HS70A 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: February 1, 2017 Received: February 8, 2017

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.

Michael D.Hara

For

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)

K163691

Device Name HS70A Diagnostic Ultrasound System

Indications for Use (Describe)

The HS70A 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-reginal, Trans-esoph, (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

Type of Use (Select one or both, as applicable)

2 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)

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3

510(k) No.:

Device Name: HS70A Diagnostic Ultrasound System Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPPNote 1Notes 2,3, 4, 5, 6, 7, 8, 9, 11
Abdominal (See Note 10)PPPPPNote 1Notes 2, 4, 6, 7, 8, 9, 11, 12, 13
Intra-operative (See Note 6)PPPPNote 1Notes 7, 9, 11
Intra-operative (Neuro.)PPPPNote 1Notes 7, 9, 11
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPPNote 1Notes 2, 4, 6, 7, 8, 9, 11
Small Organ (See Note 5)PPPPNote 1Notes 2, 5, 6, 7, 8, 9, 11, 12
Neonatal CephalicPPPPPNote 1Notes 2, 7, 8, 9, 11
Adult CephalicPPPPPNote 1Notes 7
Trans-rectalPPPPNote 1Notes 2, 7, 8, 9, 12
Trans-vaginalPPPPNote 1Notes 2, 7, 8, 9, 12
Trans-urethral
Trans-esoph. (non-Cardiac)PPPPPNote 1Notes 4, 7
Musculo-skel. (Convent.)PPPPNote 1Notes 2, 5, 6, 7, 8, 9, 11
Musculo-skel. (Superfic.)PPPPNote 1Notes 2, 5, 6, 7, 8, 9, 11
Intra-luminal
Other (See Note 13)PPPPNote 1Notes 2, 7, 8, 9, 12
Cardiac AdultPPPPPNote 1Notes 2, 4, 7
CardiacCardiac PediatricPPPPPNote 1Notes 2, 4, 7
Trans-esophageal (Cardiac)PPPPPNote 1Notes 4, 7
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPPNote 1Notes 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+DPD, B+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

4

510(k) No.:

Device Name: CA1-7A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPNote 1Notes 2, 4, 7, 8, 9, 11
Abdominal (See Note 10)PPPPNote 1Notes 2, 6, 7, 8, 9, 11, 13
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPNote 1Notes 2, 7, 8, 9, 11
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPNote 1Notes 2, 7, 8, 9, 11
Musculo-skel. (Superfic.)PPPPNote 1Notes 2, 7, 8, 9, 11
Intra-luminal
Other (See Note 13)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for 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

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

5

510(k) No.:

Device Name: CA2-8A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPNote 1Notes 2, 4, 7, 8, 9, 11
Abdominal (See Note 10)PPPPNote 1Notes 2, 4, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
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 Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for 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

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

6

510(k) No.:

Device Name: CF4-9 for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 10)PPPPNote 1Notes 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPNote 1Notes 8, 9, 11
Small Organ (See Note 5)
Neonatal CephalicPPPPNote 1Notes 8, 9, 11
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Notes 8, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)
  • Note 10: Includes Renal, Gynecology/Pelvis
  • Note 11: Panoramic imaging
  • Note 12: ElastoScan
  • Note 13: Includes Urology/Prostate

7

510(k) No.:

Device Name: E3-12A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPPNote 1Notes 2, 7, 8, 9
Abdominal (See Note 10)PPPPPNote 1Notes 2, 7, 8, 9, 12
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPNote 1Notes 2, 7, 8, 9, 12
Trans-vaginalPPPPPNote 1Notes 2, 7, 8, 9, 12
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)PPPPPNote 1Notes 2, 7, 8, 9, 12
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

8

510(k) No.:

Device Name: VR5-9 for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPPNote 1Note 2, 7, 8, 9
Abdominal (See Note 10)PPPPPNote 1Note 2, 7, 8, 9, 12
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging & OtherLaparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPPNote 1Note 2, 7, 8, 9, 12
Trans-vaginalPPPPPNote 1Note 2, 7, 8, 9, 12
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)PPPPPNote 1Note 2, 7, 8, 9, 12
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for 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

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

9

510(k) No.:

Device Name: L3-12A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPNote 1Note 2, 5, 6, 7, 9, 11
Abdominal (See Note 10)PPPPNote 1Notes 2, 4, 6, 7, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPNote 1Notes 2, 4, 6, 7, 9, 11
Small Organ (See Note 5)PPPPNote 1Note 2, 5, 6, 7, 9, 11, 12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPNote 1Note 2, 5, 6, 7, 9, 11
Musculo-skel. (Superfic.)PPPPNote 1Note 2, 5, 6, 7, 9, 11
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Note 2, 5, 6, 7, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

10

510(k) No.:

Device Name: LA3-16A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal (See Note 3)
Abdominal (See Note 10)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (See Note 5)PPPPNote 1Note 2, 5, 6, 7, 9, 11, 12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPNote 1Note 2, 5, 6, 7, 9, 11
Musculo-skel. (Superfic.)PPPPNote 1Note 2, 5, 6, 7, 9, 11
Intra-luminal
Other (See Note 13)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Note 2, 5, 6, 7, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

11

510(k) No.:

Device Name: LA3-16AI for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal (See Note 3)
Abdominal
Intra-operative (See Note 6)PPPPNote 1Note 7, 9, 11
Intra-operative (Neuro.)PPPPNote 1Note 7, 9, 11
Fetal Imaging
& OtherLaparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPNote 1Note 7, 9, 11
Musculo-skel. (Superfic.)PPPPNote 1Note 7, 9, 11
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Note 7, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)
  • Note 10: Includes Renal, Gynecology/Pelvis
  • Note 11: Panoramic imaging
  • Note 12: ElastoScan
  • Note 13: Includes Urology/Prostate

12

510(k) No.:

Device Name: LA2-9A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 10)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
Pediatric
Small Organ (See Note 5)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Musculo-skel. (Superfic.)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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 3: includes infertility monitoring 0.
Note 4: Colon M. made

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

13

510(k) No.:

Device Name: PE2-4 for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
GeneralSpecificBMPWDCWDColorCombined*Other
(Track I only)(Tracks I & III)Doppler*(Spec.)(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 10)PPPPPNote 1Note 7
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal ImagingLaparoscopic
&
OtherPediatric
Small Organ (See Note 5)
Neonatal CephalicPPPPPNote 1Note 7
Adult CephalicPPPPPNote 1Note 7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac AdultPPPPPNote 1Note 4, 7
CardiacCardiac PediatricPPPPPNote 1Note 4, 7
Trans-esophageal (Cardiac)
Other (spec.)
PeripheralPeripheral vessel
VesselOther (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

14

510(k) No.:

Device Name: PA3-8B for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 10)PPPPPNote 1Note 7
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPPNote 1Note 7
Small Organ (See Note 5)
Neonatal CephalicPPPPPNote 1Note 7
Adult CephalicPPPPPNote 1Note 7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac AdultPPPPPNote 1Note 4, 7
CardiacCardiac PediatricPPPPPNote 1Note 4, 7
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)
  • Note 10: Includes Renal, Gynecology/Pelvis
  • Note 11: Panoramic imaging
  • Note 12: ElastoScan
  • Note 13: Includes Urology/Prostate

15

510(k) No.:

Device Name: CV1-8A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPPNote 1Note 2, 4, 7, 8, 9, 11
Abdominal (See Note 10)PPPPPNote 1Note 2, 7, 8, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
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 Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

16

510(k) No.:

Device Name: LV3-14A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
GeneralSpecificBMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
(Track I only)(Tracks I & III)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 10)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
Pediatric
Small Organ (See Note 5)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Musculo-skel. (Superfic.)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)
  • Note 10: Includes Renal, Gynecology/Pelvis
  • Note 11: Panoramic imaging
  • Note 12: ElastoScan
  • Note 13: Includes Urology/Prostate

17

510(k) No.:

Device Name: V5-9 for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPNote 1Note 2, 7, 8, 9
Abdominal (See Note 10)PPPPNote 1Note 2, 7, 8, 9, 12
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPNote 1Note 2, 7, 8, 9
Trans-vaginalPPPPNote 1Note 2, 7, 8, 9
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)PPPPNote 1Notes 2, 7, 8, 9
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)
  • Note 10: Includes Renal, Gynecology/Pelvis
  • Note 11: Panoramic imaging
  • Note 12: ElastoScan
  • Note 13: Includes Urology/Prostate

18

510(k) No.:

Device Name: DP2B for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal/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 CephalicP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
CardiacCardiac AdultP
Cardiac PediatricP
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselP
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for 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

19

510(k) No.:

Device Name: CW4.0 for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)Other
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)(Spec.)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal/Obstetrics (See Note 3)
Abdominal (See Note 12)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
PediatricP
Small Organ (See Note 5)
Neonatal Cephalic
Adult CephalicP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
CardiacCardiac AdultP
Cardiac PediatricP
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselP
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

20

510(k) No.:

Device Name: CW6.0 for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal/Obstetrics (See Note 3)
Abdominal (See Note 12)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
PediatricP
Small Organ (See Note 5)
Neonatal Cephalic
Adult CephalicP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
CardiacCardiac AdultP
Cardiac PediatricP
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselP
Other (spec.)

N= new indication; P= previously cleared by FDA K152962; 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+CW, B+C+PW, B+C+PW, B+DPD+PW, B+TD+PW, B+C+M, Dual/Quad, B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for 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

21

510(k) No.:

Device Name: CA3-10A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPNote 1Notes 2, 3, 4, 7, 8, 9, 11
Abdominal (See Note 12)PPPPNote 1Notes 2, 6, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPNote 1Notes 2, 7, 8, 9, 11
Small Organ (See Note 5)
Neonatal CephalicPPPPNote 1Notes 2, 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)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Notes 2, 7, 8, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K153529; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)
  • Note 10: Includes Renal, Gynecology/Pelvis
  • Note 11: Panoramic imaging
  • Note 12: ElastoScan
  • Note 13: Includes Urology/Prostate

22

510(k) No.:

Device Name: CA2-9A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)PPPPPNote 1Notes 2, 4, 7, 8, 9, 11
Abdominal (See Note 12)PPPPPNote 1Notes 2, 4, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
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)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K153529; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

  • Note 11: Panoramic imaging

  • Note 12: ElastoScan

  • Note 13: Includes Urology/Prostate

23

510(k) No.:

Device Name: EA2-11B for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal/Obstetrics (See Note 3)PPPPNote 1Note 2, 7, 8, 9
Abdominal (See Note 12)PPPPNote 1Note 2, 6, 7, 8, 9, 12
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPNote 1Note 2, 7, 8, 9, 12
Trans-vaginalPPPPNote 1Note 2, 7, 8, 9, 12
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)PPPPNote 1Note 2, 7, 8, 9, 12
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K153529; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

  • Note 11: Panoramic imaging

  • Note 12: ElastoScan

  • Note 13: Includes Urology/Prostate

24

510(k) No.:

Device Name: LA4-18B for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 12)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
Pediatric
Small Organ (See Note 5)PPPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Musculo-skel. (Superfic.)PPPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Intra-luminal
Other (See Note 13)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPPNote 1Note 2, 5, 6, 7, 8, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K162094; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

  • Note 11: Panoramic imaging

  • Note 12: ElastoScan

  • Note 13: Includes Urology/Prostate

25

510(k) No.:

Device Name: PA4-12B for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 12)PPPPPNote 1Note 2
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPPNote 1Note 2
Small Organ (See Note 5)
Neonatal CephalicPPPPPNote 1Note 2
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 AdultPPPPPNote 1Note 4, 7
CardiacCardiac PediatricPPPPPNote 1Note 4, 7
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K162094; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

26

510(k) No.:

Device Name: PA1-5A for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 12)NNNNNNote 1Note 7
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
&
OtherLaparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal CephalicNNNNNNote 1Note 7
Adult CephalicNNNNNNote 1Note 7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac AdultNNNNNNote 1Note 4, 7
CardiacCardiac PediatricNNNNNNote 1Note 4, 7
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

27

510(k) No.:

Device Name: DP8B for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 12)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
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)
CardiacCardiac AdultN
Cardiac PediatricN
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselN
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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

  • Note 11: Panoramic imaging

  • Note 12: ElastoScan

  • Note 13: Includes Urology/Prostate

28

510(k) No.:

Device Name: MMPT3-7 for use with HS70A

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation (*includes simultaneous B-mode)
General
(Track I only)Specific
(Tracks I & III)BMPWDCWDColor
Doppler*Combined*
(Spec.)Other
(Spec.)
OphthalmicOphthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 12)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal ImagingLaparoscopic
& OtherPediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)PPPPPNote 1Note 4, 7
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)PPPPPNote 1Note 4, 7
Other (spec.)
PeripheralPeripheral vesselP
VesselOther (spec.)

N= new indication; P= previously cleared by FDA K162094; 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+CW, B+C+PW, B+C+PW, B+DPD+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: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

29

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.

1. Submitter's Information: 21 CFR 807.92(a)(1)

SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea

Contact Person:

Emily Woo Regulatory Affairs Manager

Telephone:82.2.2194.7120
Facsimile:82.2.556.3974

Data Prepared: October 20, 2016

2. Name of the device:

Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
HS70A Diagnostic Ultrasound System
Classification Names:FR NumberProduct Code
Ultrasonic Pulsed Doppler Imaging System892.1550IYN
Ultrasound Pulsed Echo Imaging System892.1560IYO

3. Identification of the predicate or legally marketed device:

  • HS70A Diagnostic Ultrasound System (K152962) -
  • -WS80A Diagnostic Ultrasound System (K153529)
  • -RS80A Diagnostic Ultrasound System (K162094; K153539; K141620)
  • A35 Diagnostic Ultrasound System (K150478) -
  • -LOGIQ E9 Diagnostic Ultrasound System (K142160)
  • -LOGIQ P7 Diagnostic Ultrasound System (K161047)

30

4. Device Description:

The HS70A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

5. Intended Uses:

The HS70A 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-vaginal, Trans-vaginal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

6. Technological Characteristics:

The HS70A is substantially equivalent with respect to safety, effectiveness, and functionality to the HS70A Diagnostic Ultrasound System (K152962), WS80A Diagnostic Ultrasound System (K153529), RS80A Diagnostic Ultrasound System (K162094; K153539), A35 Diagnostic Ultrasound System (K150478) and LOGIQ P7 Diagnostic Ultrasound System (K161047).

All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations.

These are described in detail in the technological characteristics comparison table as below.

31

| Feature /
Characteristics | | HS70A | HS70A
(K152962) | RS80A
(K162094;
K153539) | WS80A
(K153529) | A35
(K150478) | LOGIQ P7
(K161047) |
|----------------------------------------------|--------------------|--------------------|--------------------------------|--------------------------------|--------------------|-----------------------|-----------------------|
| Indication for Use | The subject device | | | | | | |
| - Fetal/Obstetrics | | √ | √ | √ | √ | √ | √ |
| - Abdominal | | √ | √ | √ | √ | √ | √ |
| - Gynecology | | √ | √ | √ | √ | √ | √ |
| - Intraoperative | | √ | √ | √ | √ | √ | √ |
| - Pediatric | | √ | √ | √ | √ | √ | √ |
| - Small Organ | | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | | √ | √ | √ | √ | √ | √ |
| - Trans-esoph.
(non-Cardiac) | | √ | √ | √ | √ | √ | |
| - Musculo-skeletal
(Conventional) | | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Superficial) | | √ | √ | √ | √ | √ | √ |
| - Urology | | √ | √ | √ | √ | √ | √ |
| - Cardiac Adult | | √ | √ | √ | √ | √ | √ |
| - Cardiac Pediatric | | √ | √ | √ | √ | √ | √ |
| - Trans-esophageal
(Cardiac) | | √ | | √ | | | |
| - Peripheral vessel | | √ | √ | √ | √ | √ | √ |
| Scanhead Types | | | | | | | |
| - Linear Array | | √ | √ | √ | √ | √ | √ |
| - Curved Linear
Array | | √ | √ | √ | √ | √ | √ |
| - Endocavity | | √ | √ | √ | √ | √ | √ |
| - Phased Array | | √ | √ | √ | √ | √ | √ |
| - Static Probes | | √ | √ | √ | √ | √ | √ |
| Scanhead Frequency | | | | | | | |
| 1.0 ~ 20.0 MHz | | √ | √ | √ | √ | √ | √ |
| Modes of Operation | | | | | | | |
| - B-mode | | √ | √ | √ | √ | √ | √ |
| - M-mode | | √ | √ | √ | √ | √ | √ |
| - Pulsed wave (PW)
Doppler | | √ | √ | √ | √ | √ | √ |
| - Continuous wave
(CW) Doppler | | √ | √ | √ | √ | √ | √ |
| - Color Doppler | | √ | √ | √ | √ | √ | √ |
| - Power Amplitude
Doppler | | √ | √ | √ | √ | √ | √ |
| - Tissue Harmonic
Imaging | | √ | √ | √ | √ | √ | √ |
| - 3D/4D imaging
mode | | √ | √ | √ | √ | √ | √ |
| Feature /
Characteristics | HS70A | HS70A
(K152962) | RS80A
(K162094;
K153539) | WS80A
(K153529) | A35
(K150478) | LOGIQ P7
(K161047) | |
| - Combined modes | √ | √ | √ | √ | √ | √ | |
| Safety & EMC
Compliance | | | | | | | |
| - IEC 60601-1 | | | | | | | |
| - UL 60601-1 | √ | √ | √ | √ | √ | √ | |
| - CSA C22.2
No.601.1 | | | | | | | |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ | √ | |
| - IEC 60601-1-2 | √ | √ | √ | √ | √ | √ | |
| Acoustic Output
Display Standard | | | | | | | |
| Track 3 | √ | √ | √ | √ | √ | √ | |
| Patient Contact
Materials | | | | | | | |
| Tested to ISO
10993-1 | √ | √ | √ | √ | √ | √ | |
| Functionality | | | | | | | |
| - Q Scan | √ | √ | √ | √ | √ | | |
| - ClearVision | √ | √ | √ | √ | √1) | | |
| - MultiVision | √ | √ | √ | √ | √2) | | |
| - Panoramic | √ | √ | √ | √ | √ | | |
| - Needle Mate+
(Needle Mate) | √(3) | √ | √ | √ | | | |
| - Auto IMT+
(Auto IMT) | √ | √ | √ | √ | √ | | |
| - Strain+ | √ | √ | √ | √ | √ | | |
| - TMAD | √ | √ | | | √ | | |
| - Arterial Analysis | √ | | √ | | | | |
| - Stress Echo | √ | √ | √ | | √ | | |
| - Elastoscan | √ | √ | √ | √ | √ | | |
| - E-Thyroid | √ | √ | √ | | | | |
| - E-Breast | √ | √ | √ | | | | |
| - S-Shearwave | √ | | √ | | | | |
| - S-Detect | √ | √ | √ | √ | | | |
| - ADVR | √ | √ | √ | √ | √ | | |
| - 3D Imaging
(Volume Data
Acquisition) | √ | √ | √ | √ | √ | √ | |
| - 3D Imaging
presentation | √ | √ | √ | √ | √ | | |
| 3D Cine/4D Cine | √ | √ | √ | √ | √ | | |
| - 3D Rendering
MPR | √ | √ | √ | √ | √ | | |
| - 3D XI
MSV/Oblique
View | √ | √ | √ | √ | √ | | |
| - 3D MXI | √ | √ | √ | √ | √ | | |
| | The subject device | | | | | | |
| Feature /
Characteristics | HS70A | HS70A
(K152962) | RS80A
(K162094;
K153539) | WS80A
(K153529) | A35
(K150478) | LOGIQ P7
(K161047) | |
| View | | | | | | | |
| - Volume CT | √ | √ | √ | √ | √ | | |
| - 3D MagiCut | √ | √ | √ | √ | √ | | |
| - Volume
Calculation
(VOCAL, XI VOCAL) | √ | √ | √ | √ | √ | | |
| - XI STIC | √ | √ | √ | √ | √ | | |
| - CEUS+ | √ | √ | √ | √ | √ | | |
| - Realistic Vue | √ | √ | √ | √ | √ | | |
| - 5D Follicle | √ | √ | √ | √ | √ | | |
| - HDVI | √ | √ | √ | √ | √ | | |
| - 5D NT | √ | √ | √ | √ | | | |
| - 5D LB | √ | √ | √ | √ | | | |
| - 5D CNS | √ | √ | √ | √ | | | |

32

33

  1. T The old name of ClearVision is DMR+ or Dynamic MR Plus.

  2. The old name of MultiVison is Spatial Compound Imaging.

  3. he name of the feature is changed to Needle Mate+ from Needle Mate.

34

7. A brief discussion of the bench and non-clinical tests conducted on the subject device

The device has been evaluated for acoustic output, biocompatibility effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform to applicable medical device safety standards.

The HS70A and its application comply with voluntary standards as below:

  • UL 60601-1, Safety requirements for Medical Equipment
  • CSA C22.2 No. 601.1. Safety requirements for Medical Equipment
  • IEC60601-2-37, Diagnostic Ultrasound Safety Standards
  • EN/IEC60601-1, Safety requirements for Medical Equipment
  • EN/IEC60601-1-2, EMC requirements for Medical Equipment
  • NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
  • NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
  • ISO10993-1, Biocompatibility
  • ISO14971, Application of risk management to medical devices

Summary of Clinical Tests:

Not applicable. The subject of this submission. HS70A, did not require clinical studies to support substantial equivalence.

8. Conclusion

Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. The design, development and quality process of the manufacturer confirms with 21 CFR 820 and ISO 13485. The device is designed to conform to applicable medical device safety standards and compliance. Therefore, SAMSUNG MEDISON CO., LTD. considers the HS70A to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary