Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms, and the description focuses on standard ultrasound technology and image processing.

Therapeutic

No
The device is described as a "multi-purpose diagnostic ultrasound system" and its intended uses are for "Diagnostic imaging or fluid flow analysis," indicating its role in diagnosis rather than therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic imaging or fluid flow analysis of the human body" and that "The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes." Furthermore, the "Device Description" directly calls it a "multi-purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states "The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and software," indicating it includes hardware components beyond just software. It also references safety standards for medical equipment that cover hardware aspects.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states "Diagnostic imaging or fluid flow analysis of the human body." This describes a device that interacts with the patient directly to produce images and measurements, not a device that analyzes samples taken from the body (which is the core of an IVD).
Device Description: The description details an "ultrasound system with accessories and software." Ultrasound is an imaging modality that uses sound waves to create images of internal structures, not a method for analyzing biological samples.
Mentions image processing: The text mentions "post processing of received echoes is performed to generate two-dimensional images of anatomic structures and fluid flow within the body." This further reinforces that the device is focused on imaging the body directly.
Input Imaging Modality: The input modality is "Ultrasonic," which is an imaging technique, not a method for analyzing biological samples.
Anatomical Site: The listed anatomical sites are all locations within the human body that are imaged directly.

IVD devices are designed to perform tests on specimens such as blood, urine, tissue, etc., to provide information about a person's health. This device is clearly designed for non-invasive imaging of the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cypress platform is intended for use in the following applications:

General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance document.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (Note 1 Cardiac), Pediatric, Neonatal Cephalic, Cardiac, Transesophageal, Peripheral vessel, Intra-Luminal, Intra-Cardiac. Modes of Operation include B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Harmonic imaging (Note 3), Contrast agent imaging (Note 4).

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

90-IYN, 90-IYO, 90-ITX, 90-DQO

Device Description

The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and I ne Offects of tware, and is substantially equivalent to our current product that is already proprietary Sollowing S10(k) Premarket Notification number K021497 (July 9, 2002) cleared as ACUSON CypressTM Ultrasound System.
The Cypress Ultrasound System has been designed to conform to the following product safety standards: CSV C22.2 No. 601-1, Safety Requirements for Medical Equipment. AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic Ultrasound. AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and ● Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. 93/42/EEC Medical Device Directive. Safety and EMC Requirements for Medical Equipment ●. EN 60601-1. EN 60601-1-1, Safety Requirements for Medical Equipment. EN 60601-1-2. EN 60601-1-2-37. ISO 10993 Biocompatibility. The system's acoustic output is in accordance with ALARA principle (as low as reasonably achicvable).

The Cypress functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic that they transmit untrasome energy may as a cases and energy back to the transducer, where post processing of received echoes is performed to generate twotransdacer, where point proxy process of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving Doppler principles are as color-coded two-dimensional images. All predicate devices thood as a specifiam, or as contred measurements of structures and flow, and provide various calculations' functions.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic

Anatomical Site

Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal, Intra-cardiac.

Indicated Patient Age Range

Not Found

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)

Not Found

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.

K021497, K032114

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

AUG 1 6 2004

Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads 'K042053' and is written in a cursive style with some characters slightly overlapping. The writing is in black ink on a white background, and the image is cropped closely around the text.

SECTION 11 510(k) Summary of Safety and Effectiveness

| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Lynch
Regulatory Affairs |
| Telephone: | 425-557-1825 |
| Fax: | 425-391-9198 |
| Submission Date: | July 23, 2004 |
| Device Name: | Cypress Ultrasound System |
| Common Name: | Diagnostic Ultrasound System with Accessories |
| Classification: | |

Regulatory Class: II Review Category: Tier II

21 CFR 892.1550

	FR #	Product Code
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
Diagnostic Intravascular Catheter	870.1200	90-DQO

Predicate Devices:

K021497 (July 9, 2002) cleared as ACUSON Cypress™ Ultrasound System. .
K032114 (July 21, 2003) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System.

1

Device Description:

The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and I ne Offects of tware, and is substantially equivalent to our current product that is already proprietary Sollowing S10(k) Premarket Notification number

K021497 (July 9, 2002) cleared as ACUSON Cypress™ Ultrasound System. .

The Cypress Ultrasound System has been designed to conform to the following product safety standards:

CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound
AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and ● Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
93/42/EEC Medical Device Directive .
Safety and EMC Requirements for Medical Equipment ●
EN 60601-1 .
- EN 60601-1-1, Safety Requirements for Medical Equipment .
- EN 60601-1-2 .
- EN 60601-1-2-37 .
ISO 10993 Biocompatibility .
The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achicvable)

Intended Use:

The Cypress platform is intended for use in the following applications:

General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance document.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Technological Comparison to Predicate Device:

The Cypress is substantially equivalent in its technologies and functionality to the Cypress Ultrasound System that is already cleared under 510(k) premarket notification number K021497.

2

The Cypress functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic that they transmit untrasome energy may as a cases and energy back to the transducer, where post processing of received echoes is performed to generate twotransdacer, where point proxy process of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving Doppler principles are as color-coded two-dimensional images. All predicate devices thood as a specifiam, or as contred measurements of structures and flow, and provide various calculations' functions.

3

Image /page/3/Picture/13 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping human profiles facing to the right.

AUG 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Patrick Lynch Regulatory Affairs Siemens Medical Solutions USA, Inc. 1230 Shorebird Way, P.O. Box 7393 MOUNTAIN VIEW CA 94039-7393

Re: K042055

Trade Name: ACUSON Cypress™ Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: July 23, 2004 Received: July 30, 2004

Dear Mr. Lynch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 mendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to r cacial Food, Drag, and Goons of the Act. The general controls provisions of the Act include the goneral of annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Transducer Model Number

7L3 Linear Array 3V2c Phased Sector Array 7V3c Phased Sector Array

4

AcuNav Intracardiac Catheter Aux CW V5Ms Phased Sector Array 5.0 MHz Biplane TEE 5.0 MHz Monoplane TEE 4C1 Curvilinear Array

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (doo as re) nrols. Existing major regulations affecting your device It may be subject to such additional vengelsi may Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of receits concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase of advised that I Dris issuanted or our device complies with other requirements of the Act that I DA has made a actorinmations administered by other Federal agencies. You must or any I cach statutes and regulaments, including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, 01); good manufacturing practice requirements as set CITY and 607), moeing (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I this device, you submit a postclearance special report. This report should contain complete the first device, you submit ation output measurements based on production line devices, requested information, merading active of the Center's September 30, 1997 "Information for Manufacturers in Appendix O, (cheroboa) or af Diagnostic Ultrasound Systems and Transducers." If the special Secking inanceling Chearanter of Dacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and rno spectar roperty marked "ADD-TO-FILE" and should be submitted in duplicate to:

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please rr you aton office of Compliance at (301) 594-4591. Additionally, for questions on the connation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket

5

Page 3 - Mr. Lynch

notification" (21 CFR Part 807.97). Other general information on your responsibilities under the nothication (21 CFR Fall 607.77). Other goll. Manufacturers, International and Consumer Act may be obtained from the Drillion of Binal Manatoniaes, 2011 -6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

6

SECTION 6 Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known):

Device Name:

ACUSON Cypress Ultrasound System

Intended Use:

Diagnostic 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	Note 3
Abdominal		P	P	P	P	P	P	Note 3
Intraoperative
(Note 1)		P	P	P	P	P	P	Note 3
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	Note 3
Small Organ
Neonatal Cephalic		P	P	P	P	P	P	Note 3
Adult Cephalic
Cardiac		P	P	P	P	P	P	Note 3,4
Transesophageal		P	P	P	P	P	P	Note 3,4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	Note 3
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Note 2)		P	P	P	P	P	P

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

For example: cardiac Note 1

Intra-Luminal, Intra-Cardiac Note 2

Harmonic imaging Note 3

Contrast agent imaging Note 4

Nancy Broydon

Division Sidr and Ra 510(k) Nun

7

510(k) Number (if known):

7L3 Linear Array Transducer for use with ACUSON Cypress

Intended Use:

Device Name:

Diagnostic 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	Note 3
Abdominal		P	P	P		P	P	Note 3
Intraoperative
(Note 1)		P	P	P		P	P	Note 3
Intraoperative
Neurological
Pediatric		P	P	P		P	P	Note 3
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P		P	P	Note 3,4
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P	Note 3
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Note 1 For example: cardiac

Harmonic imaging Note 3

Contrast agent imaging Note 4

Nancy C. Hogdon

(Division Sign-Off) Division of Reproductive, and Radiological Device 510(k) Number _

8

510(k) Number (if known):

Device Name:

3V2c Phased Sector Array Transducer for use with: ACUSON Cypress

Intended Use:

Diagnostic 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	Note 3
Abdominal		P	P	P	P	P	P	Note 3
Intraoperative
(Note 1)		P	P	P	P	P	P	Note 3
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	Note 3
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	Note 3,4
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	Note 3
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

Note 1 For example: cardiac

Harmonic imaging Note 3

Contrast agent imaging Note 4

Nancye brigdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042055

9

510(k) Number (if known):

7V3c Phased Sector Array Transducer for use with: ACUSON Cypress

Intended Use:

Device Name:

Diagnostic 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	Note 3
Abdominal		P	P	P	P	P	P	Note 3
Intraoperative
(Note 1)		P	P	P	P	P	P	Note 3
Intraoperative
Neurological
Pediatric		P	P	P	P	P	P	Note 3
Small Organ
Neonatal Cephalic		P	P	P	P	P	P	Note 3
Adult Cephalic
Cardiac		P	P	P	P	P	P	Note 3,4
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	Note 3
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

For example: cardiac Note 1

Note 3 Harmonic imaging

Contrast agent imaging Note 4

Nancy C. Hogdon

(Division Sign Division of Repro and Radiological Devi 510(k) Number

10

510(k) Number (if known):

AcuNav Intracardiac Ultrasound Catheter for use with: Device Name: ACUSON Cypress For intracardiac and intra-luminal visualization of cardiac and (great vessel r of intraodraial and visualization of other devices in the heart - use in Intended Use: right heart only.

	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
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (Note 2)		P	P	P	P	P	P

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

Intra-Luminal, Intra-Cardiac Note 2

David A. Sapper

(Division Sign-Off) Division of Reproductiv and Radiological Dev 510(k) Number

11

510(k) Number (if known):

Aux CW Transducer for use with ACUSON Cypress

Intended Use:

Device Name:

Diagnostic 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
Abdominal					P
Intraoperative
Intraoperative
Neurological
Pediatric					P
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					P
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Narenc Bragdon

(Division Sign-Off)

Division of Reproductive and Radiological Devices 510(k) Number _

12

510(k) Number (if known)

V5Ms Phased Sector Array TEE Transducer for use with: ACUSON Cypress

Device Name: Intended Use:

Diagnostic 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
(Note 1)		P	P	P	P	P	P	Note 3
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	Note 3,4
Transesophageal		P	P	P	P	P	P	Note 3,4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

and Radiological Devices

510(k) Number .

For example: cardiac Note 1

Harmonic imaging Note 3

Note 4 Contrast agent imaging

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,

13

510(k) Number (if known):

5.0 MHz Biplane TEE Transducer for use with: ACUSON Cypress

Device Name: Intended Use:

Diagnostic 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
(Note 1)		P	P	P	P	P	P	Note 3
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	Note 3,4
Transesophageal		P	P	P	P	P	P	Note 3,4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

For example: cardiac Note 1

Harmonic imaging Note 3

Note 4 Contrast agent imaging

Nancy C. Brogdon

(Division Sign-Off Division of Reproductive, and Radiological Devices 510(k) Number

14

510(k) Number (if known):

5.0 MHz Monoplane TEE Transducer for use with: ACUSON Cypress

Intended Use:

Device Name:

Diagnostic 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
(Note 1)		P	P	P	P	P	P	Note 3
Intraoperative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P	Note 3,4
Transesophageal		P	P	P	P	P	P	Note 3,4
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

For example: cardiac Note 1

Harmonic imaging Note 3

Contrast agent imaging Note 4

Nancy Broglon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042055

15

510(k) Number (if known):

4C1 Curvilinear Array Transducer for use with:

ACUSON Cypress

Intended Use:

Device Name:

Diagnostic 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		N	N	N		N	N	Note 3
Abdominal		N	N	N		N	N	Note 3
Intraoperative
(Note 1)		N	N	N		N	N	Note 3
Intraoperative
Neurological
Pediatric		N	N	N		N	N	Note 3
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N	Note 3,4
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N	Note 3
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

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

For example: cardiac Note 1

Harmonic imaging Note 3

Contrast agent imaging Note 4

Nancy C. Brogdon

(Division Sign-C Division of Reproductive, and Radiological Devices 510(k) Number _

Intended Use / Indications for Use

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

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

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.

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.

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).

§ 892.1550 Ultrasonic pulsed doppler imaging system.

SECTION 11

510(k) Summary of Safety and Effectiveness

Predicate Devices:

K021497 (July 9, 2002) cleared as ACUSON Cypress™ Ultrasound System. .

K032114 (July 21, 2003) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System.

Device Description:

K021497 (July 9, 2002) cleared as ACUSON Cypress™ Ultrasound System. .

Intended Use:

Technological Comparison to Predicate Device:

SECTION 6

Diagnostic Ultrasound Indications for Use Form

ACUSON Cypress Ultrasound System

5.0 MHz Monoplane TEE Transducer for use with: ACUSON Cypress