Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on traditional ultrasound imaging modes and features.

Therapeutic

No.
The device is a diagnostic ultrasound system intended to provide images and measurements for clinical diagnosis, not to provide therapy.

Diagnostic

Yes

The device description explicitly states, "The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and describes its function as transmitting and receiving ultrasound echo data, which requires hardware components (transducers, processing units, etc.) in addition to software.

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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The ACUSON Sequoia ultrasound system is described as a diagnostic ultrasound system that transmits and receives ultrasound echo data to create images of structures inside the body. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it provides images of, or signals from, inside the body for various anatomical applications.

Therefore, the ACUSON Sequoia is 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 ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediation, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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.

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

IYN, IYO, ITX, OIJ

Device Description

The ACUSON Sequoia 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, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes. Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts (breast, testes, thyroid, penis, prostate, etc.), OB/GYN (ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal, Peripheral Vascular, Transrectal, Transvaginal.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

appropriately trained healthcare professional in a clinical setting

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)

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

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

Not Found

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

K200707

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.

K172162

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

June 24, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K201462

Trade/Device Name: ACUSON Sequoia 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, OIJ Dated: June 1, 2020 Received: June 2, 2020

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

1

for 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)

K201462

Device Name

ACUSON Sequoia Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediation, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

FORM FDA 3881 (7/17)

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

3

510 (k) Number (if known):

Device Name:

Intended Use:

ACUSON Sequoia Diagnostic Ultrasound System

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	BMDC
Neonatal Cephalic		P	P	P		P	P	BMDC
Adult Cephalic		P	P	P		P	P	BMDC
Cardiac		P	P	P	P	P	P	BMDC
Trans-esophageal
Transrectal		P	P	P		P	P	BMDC
Transvaginal		P	P	P		P	P	BMDC	Volume Imaging
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMDC
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMDC
Musculo-skeletal
Superficial		P	P	P		P	P	BMDC
Other (specify)

N = new indication; P = previously cleared by K200707

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(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:	4V1 Phased Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(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:
Intended Use: | | DAX Curved Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|----------------------------------|---|--------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|--|
| | | Mode of Operation | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMCD | | | | |
| Abdominal | P | 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 | | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(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:

5C1 Curved Array Transducer

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

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

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

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

7

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	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Laparoscopic
Musculo-skeletal
Conventional		P	P	P		P	P	BMCD
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(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:
Intended Use: | 18L6 Linear Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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 | | | | | | | | | | |
| 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 K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

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

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

9

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

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(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):

| Device Name:
Intended Use: | 10L4 Linear Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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 | P | | BMCD | |
| Small Organ
(Note 1) | | P | P | P | P | | P | P | | BMCD | |
| Neonatal Cephalic | | P | P | P | P | | P | P | | BMCD | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | P | | BMCD | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | P | P | P | P | | BMCD | |
| Musculo-skeletal
Superficial | | P | P | P | P | P | P | P | | BMCD | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(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: Intended Use:

9EC4 Endocavity Transducer Ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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	P	BMCD
Transvaginal	P	P	P	P		P	P	BMCD
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(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:
Intended Use: | 5V1 Phased Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| | Mode of Operation | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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 | | P | P | P | | P | P | | BMCD | | | |
| Cardiac | | P | P | P | P | P | P | | BMCD | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(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):

| 8V3 Phased Array Transducer
Device Name:
Ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

(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:
Intended Use: | CW2 Continuous Wave Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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 | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

(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:	10V4 Phased Array Transducer
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric	P	P	P	P	P	P	P	BMCD
Small Organ
(Note 1)
Neonatal Cephalic		P	P	P	P	P	P	BMCD
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

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

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)

16

510 (k) Number (if known):

Device Name:	18H6 Linear Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		N	N	N		N	N	BMCD
Small Organ
(Note 1)		P	P	P		P	P	BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial		P	P	P		P	P	BMCD
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

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

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

17

510 (k) Number (if known):

| Device Name:
Intended Use: | | CW5 Continuous Wave Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|----------------------------------|---|-----------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|--|
| | | Mode of Operation | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ
(Note 1) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

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

18

510 (k) Number (if known):

Device Name:	7L2 Linear Array Transducer
Intended Use:		Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	BMCD
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

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

19

510 (k) Number (if known):

Device Name:	11M3 Curved Array Transducer
Intended Use:	Ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify)	Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric		P	P	P	P		P	P	BMCD
Small Organ
(Note 1)
Neonatal Cephalic		P	P	P	P		P	P	BMCD
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

N = new indication; P = previously cleared by K200707

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc.

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

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

20

510 (k) Number (if known):

Device Name: 9VE4 Curved Endovaginal Mechanical 3D Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

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

N = new indication; P = previously cleared by K200707

Additional Comments:

For example: breast, testes, thyroid, penis, prostate, etc. Note 1

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

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

21

510(k) Summary

Date:	May 18, 2020
1. Sponsor:	Siemens Medical Solutions USA, Inc.
Ultrasound Division
22010 South East 51st Street
Issaquah, Washington 98029
Contact Person:	Sulgue Choi
Tel: (425) 281-9898
2. Device Name:	ACUSON Sequoia Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:
II
Review Category:
Tier II
Classification Panel: 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
	Biopsy Needle Guide Kit	892.1560	90-OIJ
Manufacturing Site:	Siemens Medical Solutions USA, Inc.
22010 South East 51st Street,
Issaquah, Washington 98029, UNITED STATES

3. Legally Marketed Predicate Devices

The ACUSON Sequoia 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 Sequoia (K200707) which is primary predicated device and the ACUSON S family (K172162).

4. Device Description

The ACUSON Sequoia 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

22

ultrasound echo data and display it in B-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. Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

5. Intended Use/Indications for Use

The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal 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 modified ACUSON Sequoia Ultrasound System is the same as the company's own previously cleared ACUSON Sequoia (K200707) and the ACUSON S family (K172162) with reqard to both intended use and technological characteristics. Both the modified ultrasound system under this review and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.

The submission device differs from the predicated devices as following:

. The modified ACUSON Sequoia Ultrasound System includes the addition of the 9VE4 transducer which is substantially equivalent to the 9EVF4 transducer previously cleared on the ACUSON S family (K172162).
. The modified ACUSON Sequoia Ultrasound System includes the expansion of the 'Pediatric' clinical application for 18H6 transducer which was already cleared on the ACUSON Sequoia (K200707)
. Also this Traditional 510(k) includes 3D/4D Volume Imaging Mode which are cleared on the ACUSON S family (K172162) to enable an improved customer experience.

All other hardware and software features of the ACUSON Sequoia Diagnostic Ultrasound device remain unchanged. The foundation of the ACUSON Sequoia (this submission) is the ACUSON Sequoia(K200707) with features and transducers integrated with the ACUSON Sequoia(K200707) hardware and the ACUSON Sequoia (this submission) reuse software developed for Sequoia(K200707) mainly as well as 9VE4 transducer from S family (K172162). The submission device is substantially equivalent to the predicate with regards to both intended use and technological characteristics.

23

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON Sequoia Diagnostic Ultrasound System 510(k) Submission

Feature / Characteristic	ACUSON Sequoia This Submission	ACUSON Sequoia K# 200707 Predicate device	ACUSON S family S1000/S2000/S3000 K# 172162 Reference device
Indications for Use:
Fetal	√	√
Abdominal	√	√
Pediatric	√	√
Small Organ	√	√
Cardiac	√	√
Transrectal	√	√
Transvaginal	√	√
Peripheral vessel	√	√
Musculo-skeletal (conventional)	√	√
Musculo-skeletal (superficial)	√	√
Neonatal cephalic	√	√
Adult cephalic	√	√	√
Frequencies Supported:	(1.0MHZ~18MHz)	(1.0MHZ~18MHz)	(2.0MHz~17MHz)
Modes:
B	√	√
M	√	√
PWD (Pulsed Wave Doppler)	√	√
CWD (Continuous Wave Doppler)	√	√
PW DTI (Doppler Tissue Image)	√	√
Color Doppler	√	√
Power Doppler	√	√
Combined (BMDC)	√	√
Features:
Harmonic imaging	√	√
Panoramic imaging	√	√
Color Panoramic imaging	√	√
Auto TEQ	√	√
Cardiac Imaging physiological signal display	√	√
eSie OB	√	√
Compounding	√	√
Contrast imaging	√	√
Feature / Characteristic	ACUSON Sequoia
This Submission	ACUSON Sequoia
K# 200707
Predicate device	ACUSON S family
S1000/S2000/S3000
K# 172162
Reference device
Virtual Touch - Strain
syngo ® Velocity Vector
Imaging	√	√
eSie Calc	√	√
Speed of Sound	√	√
Fusion	√	√
Virtual Touch – pSWE	√	√
Virtual Touch - SWE	√	√
UltraArt	√	√
Modality Compare	√	√
HD Zoom	√	√
Protocols	√	√
InFocus	√	√
Flash sequencing	√	√
Gesture control	√	√
TeamViewer	√	√
Motion Stabilized
Persistence	√	√
DICOM	√	√
DICOM SR	√	√
Slow Flow Color Doppler
State	√	√
Dynamic MultiHertz	√	√
3D/4D Volume Imaging
Mode	√	√	√
(fourSight™ 4D
transducer technology)
Wireless	√	√
Monitor: 21" FPD (OLED)	√	√
Touch Screen: 15"
adjustable Touch Screen	√	√
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	√	√

ACUSON Sequoia Diagnostic Ultrasound System 510(k) Submission

24

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON Sequoia Diagnostic Ultrasound System 510(k) Submission

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, electrical, electromagnetic and mechanical safety and have

ACUSON Sequoia Diagnostic Ultrasound System 510(k) Submission

25

been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:

IEC 62359:2010. Ultrasonics Field characterization Test methods for the 트 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 O for 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: O General 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: O Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
I 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)]

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

Since the ACUSON Sequoia 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 quidelines. 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 Sequoia system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.