WS80A Diagnostic Ultrasound System

• K Number: K173513
• Device Name: WS80A Diagnostic Ultrasound System
• Manufacturer: Samsung Medison Co., Ltd.
• Date Cleared: 2018-02-20 ( 99 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatic 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 Dopler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic 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.

Predicate Devices

K171070, K171048, K142368

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI/ML, such as automated image analysis, predictive modeling, or advanced pattern recognition beyond standard ultrasound processing.

Therapeutic

No.
The device is clearly indicated as a "diagnostic ultrasound system" for "diagnostic ultrasound imaging and fluid analysis of the human body," not for therapy.

Diagnostic

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." The "Device Description" also refers to it as a "diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device is described as a "Diagnostic Ultrasound System" and includes transducers, which are hardware components essential for acquiring ultrasound data. The description also mentions evaluations for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, and electrical and mechanical safety, all of which relate to hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
• Device Function: The WS80A Diagnostic Ultrasound System is described as acquiring and displaying ultrasound data for imaging and fluid analysis of the human body. It uses ultrasound waves to create images of internal structures.
• Lack of Specimen Analysis: There is no mention of the device analyzing specimens taken from the body. Its function is based on non-invasive imaging of the body itself.

Therefore, the WS80A falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatic and Peripheral vessel.

WS80A Diagnostic Ultrasound System (Main Device)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Applications: Fetal/Obstetrics, Abdominal, Intra-operative, Intra-operative (Neuro.), Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (spec.) (See Note 13), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

SC1-6 for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

C2-6 for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10)
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

E3-12A for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Trans-rectal, Trans-vaginal, Other (spec.) (See Note 13)
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

VR5-9 for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Trans-rectal, Trans-vaginal, Other (spec.) (See Note 13)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

L3-12A for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Pediatric, Small Organ (See Note 5), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

L5-13 for use with WS80A
Clinical Applications: Small Organ (See Note 5), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

V4-8 for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

V5-9 for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Trans-rectal, Trans-vaginal, Other (spec.) (See Note 13)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

CA1-7A for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Pediatric, Musculo-skel. (Convent.), Musculo-skel. (Superfic.)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

CA2-8A for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

CF4-9 for use with WS80A
Clinical Applications: Abdominal (See Note 10), Pediatric, Neonatal Cephalic, Peripheral vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

LA3-16A for use with WS80A
Clinical Applications: Small Organ (See Note 5), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

PE2-4 for use with WS80A
Clinical Applications: Abdominal (See Note 10), Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

CV1-8A for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10)
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

LV3-14A for use with WS80A
Clinical Applications: Small Organ (See Note 5), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

CA2-9A for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

CA3-10A for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Pediatric, Peripheral vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

EA2-11B for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Trans-rectal, Trans-vaginal, Other (See Note 13)
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

LA2-9A for use with WS80A
Clinical Applications: Abdominal (See Note 10), Small Organ (See Note 5), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

LA3-16AI for use with WS80A
Clinical Applications: Intra-operative (See Note 6), Intra-operative (Neuro.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

LA4-18B for use with WS80A
Clinical Applications: Small Organ (See Note 5), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

PA3-8B for use with WS80A
Clinical Applications: Abdominal (See Note 10), Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

PM1-6A for use with WS80A
Clinical Applications: Abdominal (See Note 10), Adult Cephalic, Cardiac Adult, Cardiac Pediatric
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

EV3-10B for use with WS80A
Clinical Applications: Fetal/Obstetrics (See Note 3), Abdominal (See Note 10), Trans-rectal, Trans-vaginal, Other (See Note 13)
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

LM4-15B for use with WS80A
Clinical Applications: Small Organ (See Note 5), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel
Modes of Operation: B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

PA4-12B for use with WS80A
Clinical Applications: Abdominal (See Note 10), Pediatric, Neonatal Cephalic, Cardiac Pediatric
Modes of Operation: B, M, PWD, Color Doppler*, Combined* (Spec.), Other (Spec.)

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 Dopler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic 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, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. (Note: Specific notes define details like "thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients" for Small Organ, and "Renal, Gynecology/Pelvis" for Abdominal, and "Urology/Prostate" for Other (spec.))

Indicated Patient Age Range

Adult, Pediatric, Neonatal (implied by "neonatal cephalic", "pediatric", "adult cephalic", and explicit mention for small organs)

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)

No new hazards were identified with the subject device and its transducers have evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, been electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety 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.

K171070, K171048, K142368

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Samsung Medison Co., Ltd. Ms. Ji Yea Lee Regulatory Affairs Specialist 42, Teheran-ro 108-gil Seoul. 06176 SOUTH KOREA

February 20, 2018

Re: K173513

Trade/Device Name: WS80A Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 22, 2017 Received: November 24, 2017

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D'Hara For

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

Enclosure

2

510(k) Number (if known)

K173513

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/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult, Cardiac Pediatic and Peripheral vessel.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

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 Application		Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 3,4, 5, 6, 7, 8, 9, 11, 12
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 4, 5, 6, 7, 8, 9,10, 11, 12
	Intra-operative (See Note 6)	P	P	P		P	Note 1	Note 7, 9, 11
	Intra-operative (Neuro.)	P	P	P		P	Note 1	Note 7, 9, 11
Fetal Imaging	Laparoscopic
ంగ్ర
Other	Pediatric	P	P	P	P	P	Note 1	Notes 2, 4, 6, 7, 8, 9, 11
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11, 12
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 7
	Adult Cephalic	P	P	P	P	P	Note 1	Notes 7
	Trans-rectal	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-vaginal	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P		P	Note 1	Notes 2, 7,8, 9, 11, 12
	Cardiac Adult	P	P	P	P	P	Note 1	Notes 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Notes 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+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

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: SC1-6 for use with WS80A

4

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW. B+PD+CW. B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: C2-6 for use with WS80A

		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
Tracks I & III)	0	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	C	O	D		D	Note	Notes 2, 4, 7, 8, 9, 11

5

	Abdominal (See Note 10)	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+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 Note 13: Includes Urology/Prostate
  Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109)

6

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

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 Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Notes 2, 8, 7, 9
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+DPH+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

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

Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)
• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging
• Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: VR5-9 for use with WS80A

7

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW. B+PD+CW. B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: L3-12A for use with WS80A

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11

8

	Abdominal (See Note 10)	P	P	P	P	Note 1	Notes 2, 4, 6, 7, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P	P	Note 1	Notes 2, 4, 6, 7, 9, 11
	Small Organ (See Note 5)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+DW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: L5-13 for use with WS80A

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
Other
ళ	Pediatric

9

	Small Organ (See Note 5)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (spec.) (See Note 13)
Cardiac	Cardiac Pediatric
	Cardiac Adult
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	Note 1	Note 2, 5, 6, 7, 9, 11
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PP!, B+CW, B+C+PW, B+DPD+PW, B+DPD+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 Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V4-8 for use with WS80A

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 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

10

	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (spec.) (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, DuallQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: V5-9 for use with WS80A

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 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	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11
	Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal

11

	Other (spec.) (See Note 13)	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+DW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA1-7A for use with WS80A

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11, 13
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	Pediatric	P	P	P		P	Note 1	Notes 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.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)

12

Peripheral	Peripheral vessel
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPHPW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging) Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-8A for use with WS80A

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, ,

13

B+C+CW, B+PD+CW, B+E Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development Note 4: Color M-mode Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI) Note 8: 3D imaging Note 9: MultiVision (Spatial Compound Imaging) Note 10: Includes Renal, Gynecology/Pelvis Note 11: Panoramic imaging

• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

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 Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Notes 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
&
Other	Pediatric	P	P	P	P	P	Note 1	Notes 8, 9, 11
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Notes 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
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	Note 1	Notes 8, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+D, B+C+PW, B+D+PW, B+DPD+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)

14

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

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 Application	Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Note 1	Note 2, 5, 6, 7, 9, 11
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

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 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

15

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

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 Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Note 7
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+D, B+C+PW, B+D+PW, B+DPD+PW, B+DPD+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

16

Device Name: CV1-8A for use with WS80A

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

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P	P	P	Note 1	Note 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 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)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+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 7: Tissue Harmonic Imaging

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LV3-14A for use with WS80A

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)

17

Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
ంగ
Other	Pediatric
	Small Organ (See Note 5)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
Vessel	Other (spec.)

Additional Comments:

• Color Doppler includes Power (Amplitude) Doppler
  Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+DW, B+C+PW, B+D+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development

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

Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)
  Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

• Note 11: Panoramic imaging
• Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA2-9A for use with WS80A

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 4, 7, 8, 9, 11
	Intra-operative (See Note 6)

18

	Intra-operative (Neuro.)
Fetal Imaging
& Other	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)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+TD, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: CA3-10A for use with WS80A

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Notes 2, 3, 7, 8, 9, 11
	Abdominal (See Note 10)	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric	P	P	P		P	Note 1	Notes 2, 7, 8, 9, 11
	Small Organ (See Note 5)

19

	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
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	Note 1	Notes 2, 7, 8, 9, 11
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PP!, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EA2-11B for use with WS80A

	Clinical Application		Mode of Operation (*includes simultaneous B-mode)
	General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
	Ophthalmic	Ophthalmic
	Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9
		Abdominal (See Note 10)	P	P	P		P	Note 1	Note 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-rectal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12
		Trans-vaginal	P	P	P		P	Note 1	Note 2, 7, 8, 9, 12

20

	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	Note 1	Note 2, 7, 8, 9, 12
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, DuallQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

• Note 9: MultiVision (Spatial Compound Imaging)
• Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

• Note 12: ElastoScan
• Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA2-9A for use with WS80A

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 2, 5, 6, 7, 8, 9, 11

21

	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

• Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+TD, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E
  Note 2: Includes imaging for guidance of biopsy

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

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

• Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)

• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA3-16AI for use with WS80A Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)	P	P	P		P	Note 1	Note 7, 9, 11
	Intra-operative (Neuro.)	P	P	P		P	Note 1	Note 7, 9, 11
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P		P	Note 1	Note 7, 9, 11
	Musculo-skel. (Superfic.)	P	P	P		P	Note 1	Note 7, 9, 11
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult
	Cardiac Pediatric

22

	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel	P	P	P	P	Note 1	Note 7, 9, 11
	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPHPW, 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 8: 3D imaging
Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH)

Prescription Use (Per 21 CFR 801.109)

23

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LA4-18B for use with WS80A

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

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
Vessel	Other (spec.)

N= new indication; P= previously cleared by FDA K153529; E= added under Appendix E

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+DPH+PW, B+C+M, Dual/Quad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

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

Note 6: Abdominal organs and peripheral vessel

• Note 7: Tissue Harmonic Imaging (THI)
• Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

• Note 10: Includes Renal, Gynecology/Pelvis
• Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PA3-8B for use with WS80A

24

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
& Other	Pediatric	P	P	P	P	P	Note 1	Note 7
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P	P	P	Note 1	Note 7
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, Dual/Quad, , B+C+CW. B+PD+CW. B+E

Note 2: Includes imaging for guidance of biopsy

Note 3: Includes infertility monitoring of follicle development

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

Concurrence of Center for Devices and Radiological Health (CDRH) Prescription Use (Per 21 CFR 801.109) DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.: Device Name: PM1-6A for use with WS80A

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)

25

	Abdominal (See Note 10)	P	P	P	P	P	Note 1	Note 7
Fetal Imaging
& Other	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	Note 1	Note 7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
Cardiac	Cardiac Adult	P	P	P	P	P	Note 1	Note 4, 7
	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+DW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , 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)

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: EV3-10B for use with WS80A

Clinical Application		Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11, 12
	Abdominal (See Note 10)	P	P	P		P	Note 1	Note 2, 7, 8, 9, 11, 12
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic

Note 13: Includes Urology/Prostate

26

& Other	Pediatric
	Small Organ (See Note 5)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Trans-vaginal	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)	P	P	P	P	Note 1	Note 2, 7, 8, 9, 11, 12
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+C+PW, B+C+PW, B+DPD+PW, B+DPD+PW, B+PPHPW, B+TD+PW, B+C+M, DuallQuad, , 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 11: Panoramic Image
Note 12: ElastoScan

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: LM4-15B for use with WS80A

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General	Specific	B	M	PWD	CWD	Color	Combined*	Other
(Track I only)	(Tracks I & III)					Doppler*	(Spec.)	(Spec.)
Ophthalmic	Ophthalmic
	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
Fetal Imaging	Laparoscopic
రక
Other	Pediatric
	Small Organ (See Note 5)	P	P	P		P	Note 1	Note 2, 5, 6, 7 8, 9, 11, 12
	Neonatal Cephalic
	Adult Cephalic

27

	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Convent.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Musculo-skel. (Superfic.)	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral	Peripheral vessel	P	P	P	P	Note 1	Note 2, 5, 6, 7, 8, 9, 11
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+DW, B+C+PW, B+D+PW, B+DPD+PW, B+PPH+PW, B+TD+PW, B+C+M, DualQuad, , B+C+CW, B+PD+CW, B+E

Note 2: Includes imaging for guidance of biopsy Note 3: Includes infertility monitoring of follicle development

Note 3: Includes infertility monitori
Note 4: Color Manuals

Note 4: Color M-mode

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

Note 6: Abdominal organs and peripheral vessel

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

Note 9: MultiVision (Spatial Compound Imaging)

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan

Note 13: Includes Urology/Prostate

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

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) No.:

Device Name: PA4-12B for use with WS80A

Clinical Application			Mode of Operation (*includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal/Obstetrics (See Note 3)
	Abdominal (See Note 10)	P	P	P		P	Note 1
	Intra-operative (See Note 6)
	Intra-operative (Neuro.)
	Laparoscopic
	Pediatric	P	P	P		P	Note 1
	Small Organ (See Note 5)
	Neonatal Cephalic	P	P	P		P	Note 1
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Cardiac)

28

	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Other (See Note 13)
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P	P	P	Note 1	Note 4, 7
	Trans-esophageal (Cardiac)
	Other (spec.)
Peripheral
Vessel	Peripheral vessel
Peripheral
Vessel	Other (spec.)

Additional Comments:

Color Doppler includes Power (Amplitude) Doppler

Note 1: B+M, B+PW, B+C, B+PD, B+PPI, B+CW, B+C+PW, B+D+PW, B+DPD+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 6: Abdominal organs and peripheral vess

Note 7: Tissue Harmonic Imaging (THI)

Note 8: 3D imaging

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

Note 10: Includes Renal, Gynecology/Pelvis

Note 11: Panoramic imaging

Note 12: ElastoScan Note 13: Includes Urology/Prostate

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

29

SAMSUNG MEDISON Co., Ltd.

510(k) Premarket Notification - Traditional

Image /page/29/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 background. The oval is tilted slightly upwards from left to right.

Section 5. 510(K) Summary

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

• 1. Date Prepared - November 10, 2017
• 2. Manufacturer SAMSUNG MEDISON CO., LTD. 42, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
• Primary Contact Person 3. Ji Yea Lee Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail]
• 4. Secondary Contact Person Ninad Gujar Director of Requlatory & Quality Phone: [phone] Email: [e-mail]
• 5. Proposed Device
  • Common/Usual Name: Diagnostic Ultrasound System and Accessories
  • Proprietary Name: WS80A Diagnostic Ultrasound System -
  • Common Name: Diagnostic Ultrasound System ।
  • Classification Names: system, imaging, pulsed doppler, ultrasonic ।
  • Product Code: IYN, IYO, ITX
  • Regulation: 892.1550
• 6. Predicate Device
  • WS80A Diagnostic Ultrasound System (K171070) ।
  • RS80A Diagnostic Ultrasound System (K171048) -
  • Noblus™ Ultrasound Diagnostic System (K142368) -
• Device Description 7.

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 Dopler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic 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.

30

SAMSUNG MEDISON Co., Ltd.

510(k) Premarket Notification - Traditional

Image /page/30/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, elliptical background. The ellipse is tilted slightly, giving the logo a dynamic appearance. The font used for the word "SAMSUNG" is bold and sans-serif.

• 8. 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, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

• 9. Technology
     The WS80A employs the same fundamental scientific technology as its predicate device(s).
• 10. Determination of Substantial Equivalence
      Comparison to Predicates: The WS80A 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 WS80A and predicates WS80A systems have the same clinical intended use.

• . The WS80A and predicates WS80A systems have the same imaging modes with the exception of E-Cervix which is substantially equivalent to Hitachi Noblus (K142368).

• The WS80A and predicates WS80A systems have the same imaging modes with the exception of E-Strain, S-Detect for Breast, and S-Detect for Thyroid which are substantially equivalent to Samsung Medison RS80A (K171048).

• . The WS80A and predicate WS80A system transducers are identical.

• . The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.

• . The systems have acoustic power levels which are below the applicable FDA limits.

• The WS80A and predicate WS80A systems have the same capability in terms of performing . measurements, capturing digital images, reviewing and reporting studies.

• . The WS80A and predicate systems have been designed in compliance with approved electrical and physical safety standards.

• 11. Non-Clinical Testing

No new hazards were identified with the subject device and its transducers have evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, been electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.

• 12. Clinical Testing
      The subject of this premarket submission, WS80A, did not require clinical studies to support substantial equivalence.
• 13. 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