LogoFDA 510(k) Search
K Number
K180409
Device Name
HS40 Diagnostic Ultrasound System
Manufacturer
Samsung Medison Co, Ltd.
Date Cleared
2018-05-11

(86 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HS40 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-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Device Description
The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M 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, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 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 HS40 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
More Information

K172129, K133505, K160182

Not Found

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modes and analysis packages.

No.

The device is explicitly stated to be a "diagnostic ultrasound system" intended for "diagnostic ultrasound imaging," which is used to make a diagnosis, not to provide therapy.

Yes

The "Intended Use / Indications for Use" section explicitly states, "The HS40 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body." Additionally, the "Device Description" mentions that the system "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."

No

The device description explicitly states it is a "diagnostic ultrasound system" and mentions acquiring "ultrasound data," which inherently requires hardware components (transducers, processing unit) to generate and receive ultrasound waves. While it is "software controlled," it is not solely software.

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states the HS40 is a "diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
  • Intended Use: The intended use describes imaging and fluid analysis of the human body, not analysis of samples from the human body.
  • Device Description: The description focuses on the technical aspects of ultrasound imaging and display modes.

Therefore, the HS40 Diagnostic Ultrasound System is a medical imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The HS40 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-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

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

IYN, IYO, ITX

Device Description

The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M 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, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 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 HS40 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

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (Specific anatomical sites mentioned for transducers: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients; Renal, Gynecology/Pelvis; Abdominal organs and peripheral vessel; Urology/Prostate)

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 subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HS40 and its applications comply with voluntary standards.

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.

K172129, K133505, K160182

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

May 11, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Samsung Medison Co. Ltd. % Ji Yea Lee Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do. 25108 REPUBLIC OF KOREA

Re: K180409

Trade/Device Name: HS40 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: April 13, 2018 Received: April 16, 2018

Dear Ji Yea Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180409

Device Name HS40 Diagnostic Ultrasound System

Indications for Use (Describe)

The HS40 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-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

3

510(k) Premarket Notification - Traditional

Image /page/3/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly upwards from left to right.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: HS40 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 Imaging
& OtherFetal/Obstetrics (See Note 3)PPPPPNote 1Note 2, 7, 8, 9, 11
Abdominal (See Note 10)PPPPPNote 1Note 2, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPNote 1Note 2, 7, 8, 9, 11
Small Organ (See Note 5)PPPPNote 1Note 2, 7, 9, 11, 12
Neonatal CephalicPPPPNote 1Note 8, 9, 11
Adult CephalicPPPPPNote 1Note 7
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.)PPPPNote 1Note 2, 7, 8, 9, 11, 12
Musculo-skel. (Superfic.)PPPPNote 1Note 2, 7, 9, 11
Intra-luminal
Other (See Note 13)PPPPNote 1Note 2, 7, 9, 12
CardiacCardiac AdultPPPPPNote 1Note 4, 7, 14
Cardiac PediatricPPPPPNote 1Note 4, 7, 14
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPPNote 1Note 2, 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+TD, B+CW, B+C+PW, B+PD+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

Note 14: Tissue Doppler Imaging (TDI)

4

510(k) Premarket Notification – Traditional

Image /page/4/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA3-16AD for use with HS40

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 10)PPPPNote 1Note 2, 7, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPNote 1Note 2, 7, 9, 11
Small Organ (See Note 5)PPPPNote 1Note 2, 7, 9, 11, 12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPNote 1Note 2, 7, 9, 11, 12
Musculo-skel. (Superfic.)PPPPNote 1Note 2, 7, 9, 11
Intra-luminal
Other (See Note 13)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Note 2, 5, 7, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K172129(LA3-16A) ; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

  • Note 3: Includes infertility monitoring of follicle development
  • Note 4: Color M-mode

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

  • Note 6: Abdominal organs and peripheral vessel
  • Note 7: Tissue Harmonic Imaging (THI)
  • Note 8: 3D imaging
  • Note 9: MultiVision (Spatial Compound Imaging)
  • Note 10: Includes Renal, Gynecology/Pelvis
  • Note 11: Panoramic imaging
  • Note 12: ElastoScan Note 13: Includes Urology/Prostate
  • Note 14: Tissue Doppler Imaging (TDI)

Note 2: Includes imaging for guidance of biopsy

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

5

510(k) Premarket Notification - Traditional

Image /page/5/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-8AD for use with HS40

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)PPPPPNote 1Note 2, 7, 9, 11
Abdominal (See Note 10)PPPPNote 1Note 2, 7, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPNote 1Note 2, 7, 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 1Note 2, 7, 9, 11
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPNote 1Note 2, 7, 9, 11
Other (spec.)

N= new indication: P= previously cleared by FDA K172129; 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+TD, B+CW, B+C+PW, B+PD+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

Note 14: Tissue Doppler Imaging (TDI)

6

510(k) Premarket Notification - Traditional

Image /page/6/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CF4-9 for use with HS40

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 7, 8, 9, 11
Abdominal (See Note 10)PPPPPNote 1Notes 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPPNote 1Notes 7, 8, 9, 11
Small Organ (See Note 5)
Neonatal CephalicPPPPPNote 1Notes 7, 8, 9, 11
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPPNote 1Notes 7, 8, 9, 11
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPPNote 1Notes 7, 8, 9, 11
Other (spec.)

N= new indication: P= previously cleared by FDA K172129; 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+TD, B+CW, B+C+PW, B+PD+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

Note 14: Tissue Doppler Imaging (TDI)

7

510(k) Premarket Notification - Traditional

Image /page/7/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PN2-4 for use with HS40

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 7
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
&
OtherLaparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult CephalicPPPPNote 1Note 7
Trans-rectal (See Note 13)
Trans-vaginal (See Note 13)
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac AdultPPPPNote 1Note 4, 7, 14
CardiacCardiac PediatricPPPPNote 1Note 4, 7, 14
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K172129; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 3: Includes infertility monitoring of follicle development

  • Note 4: Color M-mode
    Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

  • Note 8: 3D imaging
    Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 2: Includes imaging for guidance of biopsy

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

8

510(k) Premarket Notification - Traditional

Image /page/8/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EVN4-9 for use with HS40

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, 9
Abdominal (See Note 10)PPPPPNote 1Note 2, 7, 9
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, 9, 12
Trans-vaginalPPPPPNote 1Note 2, 7, 9, 12
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.) (See Note 13)PPPPPNote 1Note 2, 7, 9, 12
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K172129; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

Note 3: Includes infertility monitoring of follicle development

  • Note 4: Color M-mode
    Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

  • Note 8: 3D imaging
    Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

Note 14: Tissue Doppler Imaging (TDI)

Note 2: Includes imaging for guidance of biopsy

9

510(k) Premarket Notification - Traditional

Image /page/9/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VN4-8 for use with HS40

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)PPPPPNote 1Note 2, 7, 8, 9, 11
Abdominal (See Note 10)PPPPPNote 1Note 2, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPPNote 1Note 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.)
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 K172129; E= added under Appendix E

Additional Comments:

Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+Elastoscan, B+C+PW, B+PD+PW, B+DPD+PW, B+TD+PW, B+C+M,

B+C+CW, B+PPI, B+TD, B+PPI+PW, Dual/Quad (B, B+C, B+PD, B+TD, B+DPD)

  • 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 2: Includes imaging for guidance of biopsy

Note 13: Includes Urology/Prostate Note 14: Tissue Doppler Imaging (TDI)

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

10

510(k) Premarket Notification - Traditional

Image /page/10/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V5-9 for use with HS40

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)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.)
Laparoscopic
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 1Notes 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 K172129; 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+TD, B+CW, B+C+PW, B+PD+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

Note 14: Tissue Doppler Imaging (TDI)

11

510(k) Premarket Notification - Traditional

Image /page/11/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside a blue, rounded, oval shape.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: DP2B for use with HS40

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 CephalicP
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
Cardiac AdultP
CardiacCardiac PediatricP
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselP
Other (spec.)

N= new indication; P= previously cleared by FDA K172129; 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+TD, B+CW, B+C+PW, B+PD+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

Note 14: Tissue Doppler Imaging (TDI)

12

510(k) Premarket Notification - Traditional

Image /page/12/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance. The font used for the word "SAMSUNG" is bold and sans-serif.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-8 for use with HS40

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
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.)
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 K133505; 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+TD, B+CW, B+C+PW, B+PD+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
  • Note 14: Tissue Doppler Imaging (TDI)

13

510(k) Premarket Notification - Traditional

Image /page/13/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: C2-5 for use with HS40

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)PPPPPNote 1Notes 2, 4, 7, 8, 9, 11
Abdominal (See Note 10)PPPPPNote 1Notes 2, 6, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
PediatricPPPPPNote 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.)
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 K133505; 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+TD, B+CW, B+C+PW, B+PD+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
  • Note 14: Tissue Doppler Imaging (TDI)

14

510(k) Premarket Notification - Traditional

Image /page/14/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-6BM for use with HS40

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)NNNNNote 1Notes 6, 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 xxxxxx ; 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+TD, B+CW, B+C+PW, B+PD+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 Note 14: Tissue Doppler Imaging (TDI)

15

510(k) Premarket Notification - Traditional

Image /page/15/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance. The font used for the word "SAMSUNG" is bold and sans-serif.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LN5-12 for use with HS40

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)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPNote 1Notes 2, 7, 8, 9, 11
Small Organ (See Note 5)PPPPNote 1Notes 2, 5, 7, 8, 9, 11
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)
Cardiac Adult
CardiacCardiac 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 K133505; 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+TD, B+CW, B+C+PW, B+PD+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
  • Note 14: Tissue Doppler Imaging (TDI)

16

510(k) Premarket Notification - Traditional

Image /page/16/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance. The font used for the word "SAMSUNG" is bold and sans-serif.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L5-12/50 for use with HS40

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.)
Ophthalmic
Ophthalmic
Fetal/Obstetrics (See Note 3)
Abdominal (See Note 10)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPPNote 1Notes 2, 7, 8, 9, 11
Small Organ (See Note 5)PPPPPNote 1Notes 2, 5, 7, 8, 9, 11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)PPPPPNote 1Notes 2, 7, 8, 9, 11
Musculo-skel. (Superfic.)PPPPPNote 1Notes 2, 7, 8, 9, 11
Intra-luminal
Other (See Note 13)
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vesselPPPPPNote 1Notes 2, 7, 8, 9, 11
Other (spec.)

N= new indication; P= previously cleared by FDA K133505; 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+TD, B+CW, B+C+PW, B+PD+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 Note 14: Tissue Doppler Imaging (TDI)

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

17

510(k) Premarket Notification - Traditional

Image /page/17/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The logo is simple and recognizable, and it is often used on Samsung products and in advertising.

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: ER4-9 for use with HS40

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, 7, 8
Abdominal (See Note 10)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPPPPNote 1Notes 2, 7, 8, 12, 13
Trans-vaginalPPPPNote 1Notes 2, 7, 8, 12
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 K133505; 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+TD, B+CW, B+C+PW, B+PD+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
  • Note 14: Tissue Doppler Imaging (TDI)

18

Image /page/18/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is set against a blue, oval-shaped background.

510(k) Premarket Notification - Traditional

5. 510(K) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

  • Date Prepared May 09, 2018 1.
    1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, Republic of Korea
    1. Primary Contact Person Ji Yea Lee Requlatory Affairs Specialist Phone: +82.2.2194.1594 Fax: +82.2.556.3974 Email: jiyea722.lee@samsungmedison.com

Secondardy Contact Person Scully Kim Principal Engineer Phone: +82.2.2194.1312 Fax: +82.2.556.3974 Email: scully.kim@samsungmedison.com

  • Proposed Device 4.
    • Common/Usual Name: Diagnostic Ultrasound System and Accessories
    • Proprietary Name: HS40 Diagnostic Ultrasound System ।
    • Common Name: Diagnostic Ultrasound System -
    • Classification Names: system, imaging, pulsed doppler, ultrasonic ।
    • Product Code: IYN, IYO, ITX ।
    • Regulation: 892.1550 -
    1. Predicate Device
    • HS40 Diagnostic Ultrasound System (K172129) -
    • -Sonoace R7 Diagnostic Ultrasound System (K133505)
    • -LOGIQ S7 Expert Diagnostic Ultrasound System (K160182)
    1. Device Description

The HS40 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M 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, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 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 HS40 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

    1. Intended Use
      The HS40 Diagnostic Ultrasound System and transducers are intended for diagnostic

19

510(k) Premarket Notification – Traditional

Image /page/19/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle.

ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

    1. Technology The HS40 employs the same fundamental scientific technology as its predicate device.
    1. Determination of Substantial Equivalence

Comparison to Predicate: The HS40 is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

  • The systems are all intended for diagnostic ultrasound imaging and fluid flow ● analysis
  • The HS40 and predicate HS40 have the same clinical intended use.
  • The HS40 and predicate HS40 have the same imaging modes and modes of ● operation.
  • The HS40 has Auto IMT+, Elastoscan and 5D Follicle which are same ● functionalities in the predicate HS40.
  • The transducers C2-5, C2-8, LN5-12, L5-12/50, ER4-9 are previously cleared in ● the predicate SONOACE R7 (K133505).
  • . The CA2-6BM and 3CRF-D of the predicate LOGIQ S7 (K160182) have similar clinical applications, acoustic output and evaluated to be substantial Equivalence.
  • . The system is manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
  • The system has acoustic power levels which are below the applicable FDA limits.
  • The HS40 and predicate HS40 have similar capability in terms of performing ● measurements, capturing digital images, reviewing and reporting studies.
  • The HS40 and predicate have been designed in compliance with approved electrical and physical safety standards.
    1. Summary of Non-Clinical Test

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The HS40 and its applications comply with voluntary standards.

Reference No.Title
IEC 60601-1IEC 60601-1:2005/AMD1:2012, Amendment 1 - Medical electrical equipment
  • Part 1: General requirements for basic safety and essential performance |
    | IEC 60601-1-2 | IEC 60601-1-2 Edition 3: 2007-03, Medical electrical equipment - Part 1-2:
    General requirements for basic safety and essential performance - Collateral
    standard: Electromagnetic compatibility - Requirements and tests (Edition 3) |
    | IEC 60601-2-37 | IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment - Part 2-37:
    Particular requirements for the basic safety and essential performance of
    ultrasonic medical diagnostic and monitoring equipment |
    | ISO10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical
    devices - Part 1: Evaluation and testing within a risk management process |
    | ISO14971 | ISO 14971:2007, Medical devices - Application of risk management to
    medical devices |

20

510(k) Premarket Notification - Traditional

Image /page/20/Picture/2 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded oval shape.

| NEMA UD 2-2004 | NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NEMA UD 3-2004 | NEMA UD 3-2004 (R2009)
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output
Indices on Diagnostic Ultrasound Equipment, Revision 2 |

    1. Summary of Clinical Tests
      The subject of this premarket submission, HS40, is not required clinical studies to support substantial equivalence.

12. 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 HS40 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

i END of 510(K) Summary