Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes standard ultrasound imaging modes and processing techniques.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended for imaging and measurement, providing information to the clinician for clinical diagnosis purposes, not for treatment.

Diagnostic

Yes

The device description explicitly states, "The ACUSON P200 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system." The "intended use" section also mentions "calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Diagnostic Ultrasound System" and describes its function as transmitting and receiving ultrasound echo data, which requires hardware components (transducers, processing units, etc.) beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the system is for ultrasound imaging and provides measurements and calculations that are used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. This describes a medical imaging device used for diagnosis, not a device that performs tests on biological samples in vitro (outside the body).
Device Description: The description details the function of the system as transmitting and receiving ultrasound echo data and displaying it in various imaging modes. This is consistent with an ultrasound imaging system.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on these samples.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This ultrasound system operates by sending sound waves into the body and interpreting the echoes, which is a different diagnostic modality.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures). Adult. Pediatric and Neonatal Cardiac. Pelvic. Neonatal Cephalic. Vascular. Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Breast, Thyroid, Testis), Neonatal Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral vessel (Carotid, Arterial, Venous), Musculo-skeletal Conventional, Musculo-skeletal Superficial.

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

IYN, IYO, ITX

Device Description

The ACUSON P200 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode. M-Mode. Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode. Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Parts (Breast, Thyroid, Testis), OB/GYN (ovaries, follicles, uterus, other pelvic structures), Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular (Carotid, Arterial, Venous), Cardiac (Adult, Pediatric, Neonatal), Trans-esophageal, Transrectal, Transvaginal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal.

Intended User / Care Setting

Not Found

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)

Nonclinical tests were submitted, referencing evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards. Clinical studies were not required as the device uses the same technology and principles as existing devices.

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.

K180067, K183575, K180039

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/0 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.

Siemens Medical Solutions USA, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114

August 15, 2019

Re: K191922

Trade/Device Name: ACUSON P200 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: July 17, 2019 Received: July 18, 2019

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K191922

Device Name ACUSON P200 Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

3

510 (k) Number (if known):

Device Name:

ACUSON P200 Diagnostic Ultrasound System

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMDC
Abdominal	P	P	P		P	P	BMDC
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	BMDC
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic	P	P	P		P	P	BMCD
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal	P	P	P	P	P	P	BMCD
Transrectal	P	P	P		P	P	BMCD
Transvaginal	P	P	P		P	P	BMCD
Transurethral
Intravascular
Peripheral vessel
(Note 2)	P	P	P	P	P	P	BMCD
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067; K180039; K187357

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

4

510 (k) Number (if known):

Device Name: Intended Use:

4V1 Phased Array Transducer

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMDC
Abdominal	P	P	P		P	P	BMDC
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMDC
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

For example: Breast, Thyroid, Testis Note 1 Note 2 For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

5

510 (k) Number (if known):

Device Name:

5V1 Phased Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1
Note 2

For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

6

510 (k) Number (if known):

Device Name:

8V3 Phased Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

7

510 (k) Number (if known):

Device Name:

10V4 Curved Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic	P	P	P		P	P	BMCD
Adult Cephalic
Cardiac	P	P	P	P	P	P	BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

8

510 (k) Number (if known):

Device Name:

CW2 Continuous Wave Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric				P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac				P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

9

510 (k) Number (if known):

CW5 Continuous Wave Transducer

Device Name: Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric				P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)				P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous Note 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

10

510 (k) Number (if known):

10L4 Linear Array Transducer

Device Name: Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMCD
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)	P	P	P		P	P	BMCD
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 For example: Breast, Thyroid, Testis
For example: Carotid, Arterial, Venous Note 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

11

510 (k) Number (if known):

Device Name:

14L5 Linear Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)	P	P	P		P	P	BMCD
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

12

510 (k) Number (if known):

Device Name:

18L6 Linear Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)	P	P	P		P	P	BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial	P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

13

510 (k) Number (if known):

Device Name:

5C1 Curved Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMCD
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

14

510 (k) Number (if known):

Device Name:

9C3 Curved Array Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal	P	P	P		P	P	BMCD
Abdominal	P	P	P		P	P	BMCD
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P		P	P	BMCD
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional	P	P	P		P	P	BMCD
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

15

510 (k) Number (if known):

Device Name:

9EC4 Endocavity Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal	P	P	P		P	P	BMCD
Transvaginal	P	P	P		P	P	BMCD
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K180067

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

16

510 (k) Number (if known):

Device Name:

V5Ms Multiplane TEE Transducer

Intended Use:

Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal	P	P	P	P	P	P	BMCD
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
(Note 2)
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by FDA K183575

Note 1 Note 2 For example: Breast, Thyroid, Testis For example: Carotid, Arterial, Venous

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

17

K191922

510(K) SUMMARY

Date:	August 1, 2019
1. Sponsor:	Siemens Medical Solutions USA, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043
Contact Person:	HyunJung Lee
Tel: (425) 281-5061
2. Device Name:	ACUSON P200 Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:
Review Category:
Classification Panel:	II
Tier II
Radiology
	Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
	Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
	Diagnostic Ultrasound Transducer	892.1570	90-ITX
Manufacturing Site:	Siemens Healthineers Ltd.
2nd ~ 3rd Floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Republic of Korea

3. Legally Marketed Predicate Devices

The ACUSON P200 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own ACUSON X800 (K180067) which is the primary predicate device.

The additional predicates are the indications for Neonatal Cephalic and Trans-esophageal uses which are cleared under ACUSON S3000 (K183575) and eSie Left Heart, eSie Measure, eSie Follicle and Stress Eco under ACUSON Juniper (K180039) as described in the table of section 6 Summary of Technological Characteristics.

18

4. Device Description

The ACUSON P200 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode. M-Mode. Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode. Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

5. Intended Use

The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures). Adult. Pediatric and Neonatal Cardiac. Pelvic. Neonatal Cephalic. Vascular. Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

6. Summary of Technological Characteristics

The ACUSON P200 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own products, the ACUSON X800 (K180067). ACUSON Juniper (K180039) and ACUSON S3000 (K183575) with regards to both intended use and technological characteristics. Both the subject ultrasound system and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.

The foundation of the ACUSON P200 is the ACUSON X800 with features and transducers integrated with the ACUSON X800 hardware and the ACUSON P200 reuse software developed for X800 mainly as well as some transducers from Juniper and S3000 with a connector.

| Feature / Characteristic | | ACUSON P200
Subject device | ACUSON X800
K180067 | ACUSON
Juniper
K1180039 | ACUSON S3000
K183575 |
|--------------------------------------|-----------------------------------------|-------------------------------|-------------------------------|-------------------------------|-------------------------|
| | Indications for Use: | | | | |
| ■ | Fetal | √ | √ | | |
| ■ | Abdominal | √ | √ | | |
| ■ | Pediatric | √ | √ | | |
| ■ | Small Organ | √ | √ | | |
| ■ | Cardiac | √ | √ | | |
| ■ | Neonatal Cephalic | √ | | | √ |
| ■ | Trans-esophageal | √ | | | √ |
| ■ | Transrectal | √ | √ | | |
| ■ | Transvaginal | √ | √ | | |
| ■ | Peripheral vessel | √ | √ | | |
| ■ | Musculo-skeletal
(conventional) | √ | √ | | |
| Feature / Characteristic | ACUSON P200
Subject device | ACUSON X800
K180067 | ACUSON
Juniper
K1180039 | ACUSON S3000
K183575 | |
| ■ | Musculo-skeletal (superficial) | √ | √ | | |
| | Frequencies Supported: | √
(1.0MHZ18MHz) | √
(1.0MHZ18MHz) | | |
| | Modes: | | | | |
| ■ | B | √ | √ | | |
| ■ | M | √ | √ | | |
| ■ | PWD (Pulsed Wave Doppler) | √ | √ | | |
| ■ | CWD (Continuous Wave
Doppler) | √ | √ | | |
| ■ | PW DTI (Doppler Tissue
Image) | √ | √ | | |
| ■ | Color Doppler | √ | √ | | |
| ■ | Power Doppler | √ | √ | | |
| ■ | Combined (BMDC) | √ | √ | | |
| | Features: | | | | |
| ■ | Harmonics | √ | √ | | |
| ■ | Compounding | √ | √ | | |
| ■ | UltraArt Universal Image
processing | √ | √ | | |
| ■ | Tissue Equalization (TEQ) | √ | √ | | |
| ■ | Biopsy | √ | √ | | |
| ■ | Clarify | √ | √ | | |
| ■ | Cardiac Imaging | √ | √ | | |
| ■ | Speed of Sound | √ | √ | | |
| ■ | Protocols | √ | √ | | |
| ■ | DICOM | √ | √ | | |
| ■ | eSie Calcs | √ | √ | | |
| ■ | Wireless | √ | √ | | |
| ■ | Virtual Touch Strain Imaging | √ | √ | | |
| ■ | Virtual Touch Point Shear
Wave (VTQ) | √ | √ | | |
| ■ | Virtual Touch Shear Wave
(VTIQ) | √ | √ | | |
| ■ | Contrast Agent Imaging | √ | √ | | |
| ■ | eSie OB | √ | √ | | |
| ■ | eSie Left Heart | √ | | √ | |
| ■ | eSie Measure | √ | | √ | |
| ■ | eSie Follicle | √ | | √ | |
| ■ | Panoramic Imaging | √ | √ | | |
| ■ | Stress Echo | √ | | √ | |
| ■ | Syngo Velocity Vector
Imaging (VVI) | √ | √ | | |
| ■ | eSieLink | √ | √ | | |
| ■ | DICOM SR | √ | √ | | |
| Feature / Characteristic | ACUSON P200
Subject device | ACUSON X800
K180067 | ACUSON
Juniper
K1180039 | ACUSON S3000
K183575 | |
| Touch Screen: adjustable
display | √ (13.3") | √ (15") | | | |
| Output Display Standard
(Track 3) | √ | √ | | | |
| Patient Contact Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | | | |
| UL 60601-1 Certified | √ | √ | | | |
| Indications for Use | √ | √ | | | |

The submission device is substantially equivalent to the predicate with regards to both intended use and technological characteristics.

19

Siemens Medical Solutions USA, Inc. Ultrasound Division

20

7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:

미 AIUM/NEMA UD-3:2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
미 AIUM/NEMA UD-2:2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
트 IEC 62359:2010, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / This document and its separate amendments continue to be valid together with the consolidated version.
트 Safety and EMC Requirements for Medical Equipment
- AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and o A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1.2005)
- IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for o basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version
- IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General O requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment Part 2-18: O Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment Part 2-37: Particular O requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
트 ISO 10993-1 Fourth edition 2009-10-15, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

21

8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Since the ACUSON P200 Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2016 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON P200 system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.