K Number

Device Name

ACUSON CYPRESS ULTRASOUND SYSTEM

Manufacturer

SIEMENS MEDICAL SOLUTIONS USA, INC.

Date Cleared

2005-11-10

(76 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

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

Device Description

The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number(s): K042055 (August 16, 2004) cleared as Cypress™ Ultrasound System . K021497 (July 9, 2002) cleared as Cypress™ Ultrasound System . K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System . K991872 (June 16, 1999) cleared as Lynx Ultrasound System . K982800 (September 22, 1998) cleared as Ecton Lynx 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 achievable)

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K042055, K021497, K010950, K991872, K982800, K973767

Reference Devices

K033650, K042593

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system and its accessories and software. There is no mention of AI, ML, or related technologies in the intended use, device description, or any other section. The focus is on image processing and measurement of anatomical structures, which are standard functions of ultrasound devices.

Therapeutic

No.
The intended use explicitly states "Diagnostic imaging or fluid flow analysis" and "provides information that is used for clinical diagnosis purposes," indicating a diagnostic rather than therapeutic function.

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 provides "analysis packages that provide information that is used for clinical diagnosis purposes." Furthermore, the "Device Description" identifies it as a "multi-purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

The device description explicitly states "The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software," and references compliance with hardware safety standards (e.g., EN 60601-1), indicating it includes hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The description clearly states that the Cypress system is a diagnostic ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use: The intended use describes diagnostic imaging and fluid flow analysis of the human body. This reinforces that the device is used externally or internally within the body for imaging, not for analyzing samples.
Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, preparation, or analysis of biological specimens.

Therefore, the Cypress Ultrasound System, as described, falls under the category of medical imaging devices, not In Vitro Diagnostics.

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:

For AcuNav Ultrasound Catheter: For intracardiac and intra-luminal visualization of cardiac and (great vessel anatomy and physiology, and visualization of other devices in the heart - use in right heart only.

# 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 proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number(s):

- # [K042055](https://510k.innolitics.com/search/K042055) (August 16, 2004) cleared as Cypress™ Ultrasound System .
- # [K021497](https://510k.innolitics.com/search/K021497) (July 9, 2002) cleared as Cypress™ Ultrasound System .
- # [K010950](https://510k.innolitics.com/search/K010950) (June 27, 2001) cleared as Cypress™ Ultrasound System .
- # [K991872](https://510k.innolitics.com/search/K991872) (June 16, 1999) cleared as Lynx Ultrasound System .
- # [K982800](https://510k.innolitics.com/search/K982800) (September 22, 1998) cleared as Ecton Lynx 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 achievable)

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 impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post processing of received echoes is performed to generate twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate device(s) listed above, allow for specialized 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, Great Vessel, Right Heart.

# Indicated Patient Age Range
Adult, Pediatric, Fetal, Neonatal

# 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.
[K042055](https://510k.innolitics.com/search/K042055), [K021497](https://510k.innolitics.com/search/K021497), [K010950](https://510k.innolitics.com/search/K010950), [K991872](https://510k.innolitics.com/search/K991872), [K982800](https://510k.innolitics.com/search/K982800), [K973767](https://510k.innolitics.com/search/K973767)

# 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.
[K033650](https://510k.innolitics.com/search/K033650), [K042593](https://510k.innolitics.com/search/K042593)

# 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

ACUSON Cypress™ Ultrasound System Special 510(k) Submission

2331

SECTION 11 510(k) Summary of Safety and Effectiveness

Siemens Medical Solutions USA, Inc., Ultrasound Division Sponsor: 1230 Shorebird Way P.O. Box 7393 Mountain View, California 94039-7393
Iskra Mraković Contact Person: Regulatory Affairs (650) 694-5004 Telephone: (650) 943-7053 Fax:
August 25, 2005 Submission Date:
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:

K042055 (August 16, 2004) cleared as ACUSON Cypress™ Ultrasound System. .
K021497 (July 9, 2002) cleared as ACUSON Cypress™ Ultrasound System. .
K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System. .
K991872 (June 16, 1999) cleared as Lynx Ultrasound System. .
K982800 (September 22, 1998) cleared as Ecton Lynx Ultrasound System. .
K973767 (December 23, 1997) cleared as ACUSON Sequoia™ Diagnostic . Ultrasound System.

Device Description:

R89257
2/3

K042055 (August 16, 2004) cleared as Cypress™ Ultrasound System .
K021497 (July 9, 2002) cleared as Cypress™ Ultrasound System .
K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System .
K991872 (June 16, 1999) cleared as Lynx Ultrasound System .
K982800 (September 22, 1998) cleared as Ecton Lynx 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 achievable)

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:

K052331
3/3

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 K042055.

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 impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post processing of received echoes is performed to generate twodimensional on-screen images of anatomic structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. All predicate device(s) listed above, allow for specialized measurements of structures and flow, and provide various calculations' functions.

Remainder of the page left blank intentionally.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2005

Siemens Medical Solutions USA, Inc. c/o Ms. Iskra Mrakovic Manager, Regulatory Affairs Ultrasound Division 1230 Shorebird Way Mountain View CA 94043

Re: K052331

Trade Name: Acuson Cypress Ultrasound System Regulation Number: 21 CFR 892.1550, 21 CFR 892.1560 and 21 CFR 892.1570 Regulation Name: Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System and Diagnostic Ultrasonic Transducer Regulatory Class: II (Two) Product Code: 90 IYN, IYO, and ITX Dated: August 25, 2005 Received: August 26, 2005

Dear Ms. Mrakovic:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

Page 2 - Ms. Iskra Mrakovic

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Brimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

SECTION 6 Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko52331

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

Previously cleared under K042593, K042055, K021497, K010950, K991872, and K982800.

Note 1 For example: cardiac

Intra-Luminal, Intra-Cardiac Note 2

Note 3 Harmonic imaging

Note 4 Contrast agent imaging

B.Vammumton

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052331

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko52331

Device Name:

7L3 Linear Array Transducer for use with: 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	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)

Previously cleared under # K021497.

Note 1 For example: cardiac

Note 3 Harmonic imaging

Note 4 Contrast agent imaging

Blumman

(Division Sign-Off ardiovi 510/k)

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Kos 2331

Device Name:

led Uses:

3V2c Phased Sector Array Transducer for use with 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
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)

P = previously cleared under # K982800 and #K991872.

Note 1 For example: cardiac

Note 3 Harmonic imaging

Note 4 Contrast agent imaging

Blummenstor

n Sign-Om islon of Cardlovascular Devices

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko52331

Device Name:

7 V3c Phased Sector Array Transducer for use with; 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
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P	P	P	P	Note 3
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
Other (specify)

Previously cleared under #K982800 and #K991872

Note 1 For example: cardiac

Note 3 Harmonic imaging

Note 4 Contrast agent imaging

B.Bmmmmma
(Division Sign-Off)

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Kos 2331

Device Name:

AcuNav Ultrasound Catheter for use with; ACUSON Cypress ultrasound system

Intended Use:

For intracardiac and intra-luminal visualization of cardiac and (great vessel anatomy and physiology, and visualization of other devices in the heart - use in 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

Previously cleared under # K010950, #K033650, and #K042593.

Note 2 Intra-Luminal, Intra-Cardiac

Blummo

Division Slan-O Division of Cardiovascular Devices

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko5233/

Device Name:

Aux CW Transducer for use with: 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
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)

Previously cleared under # K021497.

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

Bhimmer

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Num

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko5 2331

Device Name:

V5Ms Phased Sector Array TEE Transducer for use with; 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
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)

Previously cleared under #K973767 (on ACUSON Sequoia); TEE transducer indications cleared for use on Cypress via #K982800 and subsequent 510(k)s.

Note 1 For example: cardiac

Harmonic imaging Note 3

Note 4 Contrast agent imaging

Division Sign Off

ACUSON Cypress™ Ultrasound System Special 510(k) Submission

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko5 2331

Device Name:

5.0 MHz Biplane TEE Transducer for use with: 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
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)

Previously cleared under # K982800 and #K991872.

Note I For example: cardiac

Note 3 Harmonic imaging

Contrast agent imaging Note 4

K052331
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko52331

Device Name:

5.0 MHz Monoplane TEE Transducer for use with: 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
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)

Previously cleared under #K982800 and #K991872.

Note l For example: cardiac

Note 3 Harmonic imaging

Note 4 Contrast agent imaging

Blammura

vision Sign-Off Ivision of Cardlovascular Devices 510(k) Numbe

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko5 233/

Device Name:

4C1 Curvilinear Array Transducer for use with: 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		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

Note 1 For example: cardiac

Note 3 Harmonic imaging

Note 4 Contrast agent imaging

Blumman

Division Slan-Off Division of Cardiovascular Devices 510(k) Number

Indications for Use Form

§ 892.1550 Ultrasonic pulsed doppler imaging system.

SECTION 11

510(k) Summary of Safety and Effectiveness

21 CFR 892.1550

Predicate Devices:

K042055 (August 16, 2004) cleared as ACUSON Cypress™ Ultrasound System. .

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

K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System. .

K991872 (June 16, 1999) cleared as Lynx Ultrasound System. .

K982800 (September 22, 1998) cleared as Ecton Lynx Ultrasound System. .

K973767 (December 23, 1997) cleared as ACUSON Sequoia™ Diagnostic . Ultrasound System.

Device Description:

K042055 (August 16, 2004) cleared as Cypress™ Ultrasound System .

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

K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System .

K991872 (June 16, 1999) cleared as Lynx Ultrasound System .

K982800 (September 22, 1998) cleared as Ecton Lynx Ultrasound System .

Intended Use:

Technological Comparison to Predicate Device:

Re: K052331

SECTION 6

Diagnostic Ultrasound Indications for Use Form

ACUSON Cypress™ ultrasound system

Diagnostic Ultrasound Indications for Use Form

Diagnostic Ultrasound Indications for Use Form

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko52331

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Kos 2331

Diagnostic Ultrasound Indications for Use Form

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko5 2331

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko5 2331

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko52331

Diagnostic Ultrasound Indications for Use Form

510(k) Number (if known): Ko5 233/

4C1 Curvilinear Array Transducer for use with: ACUSON Cypress ultrasound system