← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K042055
# CYPRESS ULTRASOUND SYSTEM (K042055)
_Siemens Medical Solutions USA, Inc. · IYN · Aug 16, 2004 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K042055
## Device Facts
- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Aug 16, 2004
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric
## 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.
## Device Story
Cypress Ultrasound System is a multi-purpose diagnostic ultrasound system. It transmits ultrasonic energy into the body via a transducer; receives reflected echoes; performs post-processing to generate 2D images of anatomical structures and fluid flow. Doppler principles are used to display moving structures and flow as color-coded images. System provides measurements and analysis packages for clinical diagnosis. Used in clinical settings by healthcare professionals. Output is displayed for clinician review to aid in diagnosis and clinical decision-making. Benefits include non-invasive visualization of internal structures and hemodynamics.
## Clinical Evidence
Bench testing only. The device conforms to safety standards including CSA C22.2 No. 601-1, AIUM/NEMA UD-2 (acoustic output), AIUM/NEMA UD-3 (thermal/mechanical indices), and ISO 10993 (biocompatibility). Acoustic output adheres to the ALARA principle.
## Technological Characteristics
Diagnostic ultrasound system using pulsed echo and Doppler imaging. Transducers include linear, phased sector, curvilinear, and intracardiac catheter types. Connectivity includes standard ultrasound interfaces. Software performs signal processing and measurement calculations. Biocompatibility per ISO 10993. Safety per EN 60601-1 series.
## Regulatory 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.
## Predicate Devices
- ACUSON Cypress Ultrasound System ([K021497](/device/K021497.md))
- ACUSON Sequoia Diagnostic Ultrasound System ([K032114](/device/K032114.md))
## Submission Summary (Full Text)
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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.
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#### 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.
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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.
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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:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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
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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)
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## 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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broydon
Division Sidr and Ra 510(k) Nun
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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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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
> (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)
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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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
> (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)
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
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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
> (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)
Nancy C. Brogdon
(Division Sign-C Division of Reproductive, and Radiological Devices 510(k) Number _
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K042055](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K042055)
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