K Number
K143089
Device Name
WS80A Diagnostic Ultrasound System
Date Cleared
2014-11-26

(29 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WS80A 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
Device Description
The WS80A 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, 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, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The WS80A 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 WS80A 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 summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound imaging modes and analysis packages, without mentioning any AI/ML capabilities.

No
The device is described as a "diagnostic ultrasound system" and its intended use is for "diagnostic ultrasound imaging and fluid analysis," indicating it's used for diagnosis rather than treatment.

Yes

The "Intended Use / Indications for Use" section explicitly states, "The WS80A 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," which is a hardware device that uses software for control and image processing, but is not solely software.

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

Here's why:

  • Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid analysis of the human body." This describes a device that images the body directly using ultrasound waves, not a device that analyzes samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
  • Device Description: The description details how the device acquires and displays ultrasound data in various modes (B mode, M mode, Doppler, etc.) and provides measurement and analysis packages. This aligns with the function of an ultrasound imaging system.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging system that uses physical principles (ultrasound) to visualize internal structures.

N/A

Intended Use / Indications for Use

The WS80A 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, 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 WS80A 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, 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, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The WS80A 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 WS80A 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (Specific notes further detail: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients, Renal, Pelvis, Prostate)

Indicated Patient Age Range

Adult, Pediatric, Neonatal (implied by "Neonatal Cephalic", "Pediatric", and "Cardiac Adult")

Intended User / Care Setting

Competent health care professionals (implied by diagnosis and clinical applications).

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)

Not applicable. The subject of this submission. WS80A, 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.

K133329, K141620, K132861, K122327, K130739

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 U.S. Department of Health & Human Services. 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 right, stacked on top of each other, with a flowing design element extending from the bottom profile.

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

November 26, 2014

Samsung Medison Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street, NW BUFFALO MN 55313

Re: K143089

Trade/Device Name: WS80A 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: October 27, 2014 Received: October 28, 2014

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.

This determination of substantial equivalence applies to the following transducers intended for use with the WS80A Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

SC1-6C2-6E3-12A
VR5-9L3-12AL5-13
V4-8V5-9CA1-7A
CA2-8ACF4-9LA3-16A
PE2-4CV1-8ALV3-14A

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

1

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

for

Janine M. Morris 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)

K143089

Device Name

WS80A Diagnostic Ultrasound System

Indications for Use (Describe)

The WS80A 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

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

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)

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 Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

3

510(k) No.:

Device Name: WS80A 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)PPPPNote 1Notes 2, 4, 5, 6, 7, 8, 9, 11
Abdominal (See Note 10)PPPPPNote 1Notes 2, 7, 8, 9, 11, 12
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Fetal Imaging
& OtherLaparoscopic
PediatricPPPPNote 1Notes 8, 9, 11
Small Organ (See Note 5)PPPPNote 1Note 2, 5, 6, 7, 8, 9, 11, 12
Neonatal CephalicPPPPPNote 1Notes 7, 8, 9, 11
Adult CephalicPPPPPNote 1Notes 7
Trans-rectalPPPPNote 1Notes 2, 7, 8, 9, 11, 12
Trans-vaginalPPPPNote 1Notes 2, 7, 8, 9, 11, 12
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 (spec.) (See Note 13)PPPPNote 1Notes 2, 7, 8, 9, 12
CardiacCardiac AdultPPPPPNote 1Notes 4, 7
Cardiac PediatricPPPPPNote 1Notes 4, 7
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 K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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: SC1-6 for use with WS80A

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 10)PPPPPNote 1Notes 2, 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 (spec.) (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 K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, B+PPF+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 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 4: Color M-mode

5

510(k) No.:

Device Name: C2-6 for use with WS80A

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, 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 (spec.) (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 K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPF+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

6

510(k) No.:

Device Name: E3-12A for use with WS80A

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
Abdominal (See Note 10)PPPPPNote 1Notes 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 7, 8, 9, 12
Trans-vaginalPPPPPNote 1Notes 7, 8, 9, 12
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.) (See Note 13)PPPPPNote 1Notes 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 K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, B+PPF+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 8: 3D imaging
    Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

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)

7

510(k) No.:

Device Name: VR5-9 for use with WS80A

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)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 ImagingLaparoscopic
&
OtherPediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectalPbPbNote 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 (spec.) (See Note 13)PPPPNote 1Notes 2, 7, 8, 9, 12
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
PeripheralPeripheral vessel
VesselOther (spec.)

N= new indication; P= previously cleared by FDA K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, B+PPF+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

8

510(k) No.:

Device Name: L3-12A for use with WS80A

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)PPPPNote 1Note 2, 5, 6, 7, 9, 11
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, 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 (spec.) (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 K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PD+PW, B+PPF+W, B+PPF+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 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 4: Color M-mode

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

9

510(k) No.:

Device Name: L5-13 for use with WS80A

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
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 (spec.) (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 K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, B+PPF+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

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

10

510(k) No.:

Device Name: V4-8 for use with WS80A

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 (spec.) (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 K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, B+PPF+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

11

510(k) No.:

Device Name: V5-9 for use with WS80A

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
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
Trans-vaginalPPPPPNote 1Note 2, 7, 8, 9
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.) (See Note 13)PPPPPNote 1Notes 2, 7, 8
Cardiac Adult
CardiacCardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K133329; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CV, B+C+PW, B+PD+PW, B+PPF+W, B+PPF+W, B+PPF+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 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 4: Color M-mode

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

12

510(k) No.:

Device Name: CA1-7A for use with WS80A

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 10)PPPPPNote 1Notes 2, 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 K141620; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+TD, B+CW, B+C+PW, B+PD+PW, B+PPF+W, B+PPH+W, B+ID+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

13

510(k) No.:

Device Name: CA2-8A for use with WS80A

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, 4, 7, 8, 9, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (See Note 13)
CardiacCardiac Adult
Cardiac Pediatric
Trans-esophageal (Cardiac)
Other (spec.)
Peripheral
VesselPeripheral vessel
Other (spec.)

N= new indication; P= previously cleared by FDA K132861; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPH+PW, B+ID+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 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 4: Color M-mode

14

510(k) No.:

Device Name: CF4-9 for use with WS80A

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)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 K141620; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+DD+PW, B+DPD+PW, B+PPI+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

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

15

510(k) No.:

Device Name: LA3-16A for use with WS80A

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 K132861; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+PD+PW, B+PD+PW, B+PPI+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

16

510(k) No.:

Device Name: PE2-4 for use with WS80A

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
Pediatric
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 K141620; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPI, B+ID, B+CW, B+C+PW, B+DD+PW, B+DPD+PW, B+PPI+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

17

510(k) No.:

Device Name: CV1-8A for use with WS80A

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)NNNNNNote 1Note 2, 4, 7, 8, 9, 11
Abdominal (See Note 10)NNNNNNote 1Note 2, 7, 8, 11
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (See Note 5)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.) (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; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+DPD+PW, B+PPI+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 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients

  • 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 4: Color M-mode

Note 6: Abdominal organs and peripheral vessel

18

510(k) No.:

Device Name: LV3-14A for use with WS80A

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)
Intra-operative (See Note 6)
Intra-operative (Neuro.)
Laparoscopic
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 K141620; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+DPD, B+PPI, B+CW, B+C+PW, B+PD+PW, B+PPF+PW, B+PPH+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) 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: Kyeong-Mi, Park

Regulatory Affairs Manager

Telephone:82.2.2194.1373
Facsimile:82.2.556.3974

Data Prepared: September 24, 2014

2. Name of the device:

Common/Usual Name: Diagnostic Ultrasound System and Accessories Proprietary Name: WS80A Diagnostic Ultrasound System Classification Names: FR Number Product Code IYN Ultrasonic Pulsed Doppler Imaging System 892.1550 Ultrasound Pulsed Echo Imaging System 892.1560 IYO Diagnostic Ultrasound Transducer 892.1570 ITX

3. Identification of the predicate or legally marketed device:

  • UGEO WS80A Diagnostic Ultrasound System (K133329) -
  • RS80A Diagnostic Ultrasound System (K141620) -
  • -UGEO H60 Diagnostic Ultrasound System (K132861)
  • Voluson E8 Diagnostic Ultrasound System (K122327) -
  • -ACUSON S2000 Diagnostic Ultrasound System (K130739)

20

4. Device Description:

The WS80A 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, 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, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The WS80A 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 WS80A 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 WS80A 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, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

6. Technological Characteristics:

The WS80A is substantially equivalent with respect to safety, effectiveness, and functionality to the UGEO WS80A Diagnostic Ultrasound System (K133329), RS80A Diagnostic Ultrasound System (K141620) and UGEO H60 Diagnostic Ultrasound System (K132861).

It is substantially equivalent with respect to safety, effectiveness, and functionality to the [Syngo Auto OB Measurments®] of Siemens's ACUSON S2000 (K130739) in regards to the device with [5D CNS]. It is substantially equivalent with respect to safety, effectiveness, and functionality to the [SonoAVC follicle® and SonoVCAD heart®] of GE's Voluson E8 (K122327) in regards to the device with [5D Follicle and 5D Heart].

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.

21

WS80A (V2.00)Comment
Model Name• Change of model name in the V2.00The model name in the V1.00 is UGEO WS80A.
Clinical application• Addition of clinical applications : Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric
Operation of modes• Addition of Continuous Wave (CW) Spectral Doppler
Applied transducers• Addition of 7 transducers : CA1-7A, CA2-8A, CF4-9, LA3-16A, PE2-4, CV1-8A and LV3-14A.Transducers The previously cleared transducers CA1-7A K141620 CA2-8A K132861 (CF2-8) CF4-9 K141620 LA3-16A K132861 (LF5-13) PE2-4 K141620 LV3-14A K141620 CV1-8A None
SW Features• Addition of S/W Features : (new) 5D CNS, 5D Follicle and 5D Heart (previously cleared) RMS
• Change of S/W feature's name : SCI→MultiVision, SDMR→ClearVision, FRV→Realistic VueDescription of S/W Features
• 5D CNS: This feature assists with diagnosis by taking measurements relating to fetal brain.
• 5D Follicle: This feature assists with diagnosis by estimating the size and volume of a follicle in the ovary
• 5D Heart: This feature assists with diagnosis of fetal heart conditions by using the STIC data of the fetus.
• RMS: This feature is the collection of error data in the ultrasound imaging system, utilization logging, and the control of remote device. The collected data is transmitted to the RMS server over a network for customer service.
HW Features• Change of Monitor size and Physical Dimensions
• Addition of CW Probe Port

22

| Feature / Characteristics | The subject
device
WS80A | UGEO WS80A
(K133329) | RS80A
(K141620) | The predicate devices
UGEO H60
(K132861) | Voluson E8
(K122327) | ACUSON
S2000
(K130739) |
|-----------------------------------------------|--------------------------------|-------------------------|--------------------|------------------------------------------------|-------------------------|------------------------------|
| Indication for Use | | | | | | |
| - Fetal/Obstetrics | √ | √ | √ | √ | √ | √ |
| - Abdominal | √ | √ | √ | √ | √ | √ |
| - Gynecology | √ | √ | √ | √ | √ | √ |
| - Pediatric | √ | √ | √ | √ | √ | √ |
| - Small Organ | √ | √ | √ | √ | √ | √ |
| - Neonatal Cephalic | √ | √ | √ | √ | √ | √ |
| - Adult Cephalic | √ | √ | √ | √ | √ | √ |
| - Trans-rectal | √ | √ | √ | √ | √ | √ |
| - Trans-vaginal | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Conventional) | √ | √ | √ | √ | √ | √ |
| - Musculo-skeletal
(Superficial) | √ | √ | √ | √ | √ | √ |
| - Urology | √ | √ | √ | √ | √ | √ |
| - Cardiac Adult | √ | √ | √ | √ | √ | √ |
| - Cardiac Pediatric | √ | √ | √ | √ | √ | √ |
| - 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 | √ | √ | √ | √ | √ | √ |
| - Combined modes | √ | √ | √ | √ | √ | √ |
| Safety & EMC | | | | | | |
| Compliance | | | | | | |
| - IEC 60601-1 | | | | | | |
| - UL 60601-1 | √ | √ | √ | √ | √ | √ |
| - CSA C22.2 No 601 1 | | | | | | |
| | The subject device | The predicate devices | | | | |
| Feature / Characteristics | WS80A | UGEO WS80A
(K133329) | RS80A
(K141620) | UGEO H60
(K132861) | Voluson E8
(K122327) | ACUSON
S2000
(K130739) |
| - IEC 60601-2-37 | √ | √ | √ | √ | √ | √ |
| - IEC 60601-1-2 | √ | √ | √ | √ | √ | √ |
| Acoustic Output Display
Standard | | | | | | |
| Track 3 | √ | √ | √ | √ | √ | √ |
| Patient Contact
Materials | | | | | | |
| Tested to ISO 10993-1 | √ | √ | √ | √ | √ | √ |
| Functionality | | | | | | |
| - Quick Scan (Q Scan) | √ | √ | √ | √ | | |
| - Spatial Compound
Imaging | √1) | √ | √ | √ | | |
| - SMDR (SMDR evo) | √2) | √ | √ | √ | | |
| - Auto IMT+
(Auto IMT) | √ | √ | √ | √ | | |
| - Elastoscan | √ | √ | √ | | | |
| - Panoramic | √ | √ | √ | | | |
| - 3D Imaging
(Volume Data
Acquisition) | √ | √ | √ | √ | | |
| 3D Imaging
presentation | | | | | | |
| 3D Cine/4D Cine | √ | √ | √ | √ | | |
| 5D Cine | √ | √ | | | | |
| - 3D Rendering
MPR(Multi Planer
Render) | √ | √ | √ | √ | | |
| - 3D XI
MSV(Multi Slice
View) | √ | √ | √ | √ | | |
| Oblique View | | | | | | |
| - 3D MXI
Volume Slice, Mirror
View | √ | √ | √ | | | |
| - XI Volume CT
(Volume CT) | √ | √ | √ | | | |
| - 3D MagiCut | √ | √ | √ | √ | | |
| - Volume Calculation
(VOCAL, XI
VOCAL) | √ | √ | √ | √ | | |
| - XI STIC | √ | √ | √ | | | |
| - HDVI | √ | √ | √ | | | |
| - FRV | √3) | √ | | | | |
| - Volume NT/IT | √ | √ | √ | √ | | |
| - 5D NT | √ | √ | | | | |
| - 2D NT | √ | √ | | | | |
| | The subject
device | The predicate devices | | | | |
| Feature / Characteristics | WS80A | UGEO WS80A
(K133329) | RS80A
(K141620) | UGEO H60
(K132861) | Voluson E8
(K122327) | ACUSON
S2000
(K130739) |
| - 5D LB | √ | √ | | | | |
| - MPI | √ | √ | | | | |
| - 5D CNS | √ | | | | | √(4) |
| - 5D Follicle | √ | | | | √(5) | |
| - 5D Heart | √ | | | | √(6) | |

23

24

  1. The name of the feature is changed to MultiVison.

  2. The name of the feature is changed to Clear Vision

  3. The name of the feature is changed to Realistic Vue.

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 WS80A 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. WS80A, 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 WS80A to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

END of 510(K) Summary