ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K123001 |
|---|---|
| Device Name | ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 26, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Retal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients
Device Story
Multi-purpose mobile diagnostic ultrasound system; acquires harmonic ultrasound echo data; displays in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Color M, Tissue Doppler, Amplitude Doppler, Harmonic, 3D, and 4D imaging. Operated by clinicians in clinical settings. System processes received echoes to generate anatomical/flow displays; provides measurement/analysis packages (e.g., Arterial Health Package for Intima Media Thickness). Output viewed on flat panel display; assists clinical diagnosis and patient communication. Benefits include non-invasive visualization of anatomy/physiology and assessment of cardiovascular risk.
Clinical Evidence
No clinical data submitted. Substantial equivalence based on bench testing, including acoustic output, biocompatibility, and electrical/mechanical safety standards (IEC 60601 series, AIUM/NEMA UD-2/UD-3, ISO 10993-1).
Technological Characteristics
Mobile ultrasound system; flat panel display; supports various transducers (curved, linear, phased array, intracardiac). Materials conform to ISO 10993-1. Connectivity includes standard ultrasound interfaces. Software-controlled; complies with IEC 60601-2-37 and UL 60601-1. Sterilization/disinfection per manufacturer guidelines.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult and pediatric patients across cardiac, vascular, abdominal, fetal, small organ, musculoskeletal, and urological applications. Includes intra-operative and intracardiac visualization. Contraindications not specified.
Regulatory Classification
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
- Siemens ACUSON X300 (K121699)
- Siemens ACUSON S2000 (K112596)
- Ultrasonix SonixTABLET (K113663)
- Ultrasonix SonixTABLET (K102997)
Related Devices
- K180039 — ACUSON P600 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Feb 1, 2018
- K121699 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jun 22, 2012
- K130619 — ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Mar 21, 2013
- K132804 — ACUSON S1000 / S2000 / S3000 · Siemens Medical Solutions USA, Inc. Ultrasound Gro · Oct 24, 2013
- K172374 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Aug 15, 2017
Submission Summary (Full Text)
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K123001
ACUSON X700 ™ Ultrasound System 510(k) Submission
## 510(k) Summary Prepared August 22, 2012
OCT 2 6 2012 Sponsor: Siemens Medical Solutions, Inc., Ultrasound Division 685 East Middlefield Road Mountain View, California 94043 Contact Person: Shelly Pearce (650) 694-5988 Telephone: (650) 694-5580 Fax: ACUSON X700™ Ultrasound System Device Name: Common Name: Diagnostic Ultrasound System with Accessories Classification: Requlatory Class: ll Review Category: Tier II Classification Panel: Radiology
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
|------------------------------------------|---------------|---------------------|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
| Diagnostic Intravascular Catheter | FR # 870.1200 | Product Code OBJ |
## A. Legally Marketed Predicate Devices
The Siemens ACUSON X700™ Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product, the Siemens ACUSON X300 ultrasound system (K121699), ACUSON S2000 ultrasound system (K112596) and Ultrasonix SonixTABLET ultrasound scanner (K113663, K102997).
## B. Device Description:
The Siemens ACUSON X700™ is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
## C. Intended Use
The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Retal, Abdominal, Intra-operative,
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Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients
## D. Substantial Equivalence
The Acuson X700 is substantially equivalent to the Acuson X300, cleared via K121699, and Acuson S2000, cleared via K112596 and SonixTABLET ultrasound scanner cleared via K113663. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
## E. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- UL 60601-1. Safety Requirements for Medical Equipment .
- l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment l
- l AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- l AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- l 93/42/EEC Medical Devices Directive
- 트 Safety and EMC Requirements for Medical Equipment
- D EN/IEC 60601-1
- I EN/IEC 60601-1-1
- EN/IEC 60601-1-2
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- . EN/IEC 60601-1-4
- EN/IEC 60601-1-6
- EN/IEC 60601-2-18 .
- . EN/IEC 60601-2-25
- I IEC 1157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility .
Cleared patient contact materials, electrical and mechanical safety are unchanged.
## F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the X700 uses the same technology and principles as existing devices, clinical data is not required.
### G. Summary
Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the X700 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
The Acuson X700 is verified and validated according to the company's design control process.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 26 2012
Siemens Medical Solutions USA, Inc. - Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K123001
Trade/Device Name: Acuson X700TM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO. ITX, and OBJ Dated: September 26, 2012 Received: September 27, 2012
Dear Mr. Job:
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 Amendments, 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 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Acuson X700™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
4C1 Curved Array VF10-5 Linear Array VF12-4 Linear Array EC9-4w Convex Array 6C2 Curved Array CW2 CWS AcuNav 8F Intracardiac AcuNav 10F Intracardiac
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## V5Ms TEE 4V1c Phased Array C7F2 Curved Array EV9F4 Curved Array SoundStar 10F SoundStar eco 10F
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.
Sincerely Yours,
Michael O'Brien for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure(s)
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## Tab 1.3.1 Indications for Use Forms
#### Indications for Use Statement
510(k) Number (if known):
ACUSON X700™ Diagnostic Ultrasound System Device Name:
Indications For Use:
The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatai Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeleta! Conventional, Musculoskeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arnhard Döhmen
Office of In Vitro Diagnostic Devices
510(k) K123061
Page 1 of __
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510(k) Number (if known):
Device Name:
Intended Use:
# ACUSON X700 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|---|---|-----|-----|------------------|------------------|-----------------------|-------------------------------------|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,12,19,21 |
| | Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10,11,20 |
| | Intra-operative<br>(Note 6) | P | P | P | P | P | P | BMDC | Note 2,3,4,5,9,10 |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| Fetal | Laparoscopic<br>Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10,11 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11,19 |
| | Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,9,10,11 |
| | Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Trans-rectal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10,19 |
| | Trans-vaginal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10,12,19, 21 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | p | | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Intra -vascular | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,15,16 |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2,7,8,9, 13, 14,15,16,17,18,19 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,6,8,9,10,13,14,15,16 |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,15,16 |
| | Trans-esophageal<br>(Cardiac) | P | P | P | P | P | P | BMDC | Note 2,7,9,14,17,18,19 |
| | Intra-Cardiac | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,15,16 |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | p | BMDC | Note 2,3,4,6,9,10,11 |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared by K121699, K112596
Office of In Vitro
Division Sign-Off
510(k)
Diagnostic Devices
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 11 syngo Arterial Health Package (AHP) Note 2 Dynamic TCE Technology Note 12 syngo Auto OB Measurements syngo Auto Left Heart (Auto LH) Technology Note 3 SieClear Note 13 Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 6 For example: abdominal, vascular Note 16 Intracardiac Echocardiography (ICE) Imaging Note 7 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging SieScape Panoramic Imaging Note 10 Note 20 Contrast Agent Imaging syngo Auto follicle Note 21
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 2 of
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510(k) Number (if known):
Device Name:
Intended Use:
4C1 Curved Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|------------------------|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,12 | |
| | Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10,20 | |
| | Intra-operative<br>(Note 6) | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal · | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 | |
| Vessel | Other (Specify) | | | | | | | | | |
N = new indication; P = previously cleared by K112596
Note 11 syngo Arterial Health Package (AHP) Note 1 For example: breast, testes, thyroid, penis, prostate, etc. syngo Auto OB Measurements Note 12 Dynamic TCE Technology Note 2 syngo Auto Left Heart (Auto LH) Technology SieClear Note 13 Note 3 syngo Velocity Vector Imaging Technology Note 14 Advanced SieClear Note 4 Note 15 CartoSound Communication Note 5 3-Scape 3D Imaging Intracardiac Echocardiography (ICE) Imaging Note 6 For example: abdominal, vascular Note 16 Note 7 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging Note 20 Contrast Agent Imaging Note 10 SieScape Panoramic Imaging Note 21 syngo Auto follicle (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001
Page 3 of
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510(k) Number (if known):
Device Name:
VF10-5 Linear Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------|--|
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks1I& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Intra-operative<br>(Note 6) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Neonatal Cephalic | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Adult Cephalic | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Intra-vascular | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Other (Specify) | | | | | | | | | |
N = new indication; P = previously cleared K121699
Note 11 syngo Arterial Health Package (AHP) Note 1 For example: breast, testes, thyroid, penis, prostate, etc. syngo Auto OB Measurements Note 2 Dynamic TCE Technology Note 12 syngo Auto Left Heart (Auto LH) Technology Note 3 SieClear Note 13 Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 16 Intracardiac Echocardiography (ICE) Imaging For example: abdominal, vascular Note 6 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 7 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 8 syngo fourSinght 4D imaging Clarify Vascular Enhancement Technology Note 19 Note 9 Note 20 Contrast Agent Imaging Note 10 SieScape Panoramic Imaging syngo Auto follicte Note 21 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
( Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
concurrence
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001
Page 4 of
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510(k) Number (if known):
Device Name:
Intended Use:
VF12-4 Linear Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------|--|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal<br>Abdominal | | | | | | | | | | |
| | | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| | Neonatal Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| | Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| | Musculo-skel.<br>(Superfic) | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | | |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Dynamic TCE Technology
- Note 3 SieClear Note 4 Advanced SieClear
- Note 5 3-Scape 3D Imaging
- Note 6 For example: abdominal, vascular
- Note 7 Stress Echo Imaging
- Note 8 Axius Edge Assisted Ejection Fraction
- Clarify Vascular Enhancement Technology Note 9
- SieScape Panoramic Imaging Note 10
-
- Note 11 syngo Arterial Health Package (AHP)
- Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology
- Note 14 syngo Velocity Vector Imaging Technology
- Note 15 CartoSound Communication
- Intracardiac Echocardiography (ICE) Imaging Note 16
- Note 17 syngo fourSight TEE View
- Note 18 syngo Mitral Valve Assessment (MVA)
- Note 19 syngo fourSinght 4D imaging
- Note 20 Contrast Agent Imaging Note 21 syngo Auto follicle
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001
{10}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
EC9-4w Convex Array Transducer for use with: ACUSON 7300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation Other Power Combined Other Color Specific B M PWD CWD ( Track 1 Dopoler (Specify) Doppler (Specify) (Tracks11& 3) Only) Ophthalmic Ophthalmic N BMDC Note 2,3,4,5,6,9,10,12, 21 Fetal N Z ਮ N Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric Imaging SmallOrgan BMDC મ N N N N Note 2,3,4,5,9,10 & Other (Note 1) BMDC Note 2,3,4,5,9,10 Neonatal Cephalic N N પ N N Adult Cephalic Trans-rectal N N N N N BMDC Note 2,3,4,5,9,10 . N N ਮ BMDC Note 2,3,4,5,9,10,12, 21 Trans-vaginal N N Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic) Intra-vascular Other (Specify) Cardiac Adult Cardiac Cardiac Pediatric Intra-vascular (Cardiac) Trans-esophageal (Cardiac) Intra-Cardiac Other (Specify) Peripheral Peripheral vessel Other (Specify) Vessel N = new indication; P = previously cleared
N = new indication; P = previously cleared
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 11 syngo Arterial Health Package (AHP) Dynamic TCE Technology Note 2 Note 12 syngo Auto OB Measurements Note 3 SieClear Note 13 syngo Auto Left Heart (Auto LH) Technology Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 6 For example: abdominal, vascular Note 16 Intracardiac Echocardiography (ICE) Imaging Note 7 Stress Echo Imaging Note 17 syngo fourSight TEE View Note 8 Axius Edge Assisted Ejection Fraction syngo Mitral Valve Assessment (MVA) Note 18 Clarify Vascular Enhancement Technology Note g Note 19 syngo fourSinght 4D imaging Note 10 SieScape Panoramic Imaging Note 20 Contrast Agent Imaging syngo Auto follicle Note 21
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Concurrence d
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001
Page 6 of _
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
6C2 Curved Array Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|------------------------|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1I& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,12 |
| | Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 |
| | Intra-operative<br>(Note 6) | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| Fetal | Laparoscopic | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared K112596
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 2 Dynamic TCE Technology
- Note 3 SieClear
- Note 4 Advanced SieClear 3-Scape 3D Imaging
- Note 5 For example: abdominal, vascular Note 6
- Stress Echo Imaging Note 7
- Axius Edge Assisted Ejection Fraction Note 8
- Clarify Vascular Enhancement Technology Note 9
- Note 10 SieScape Panoramic Imaging
- Note 15 CartoSound Communication Note 16 Intracardiac Echocardiography (ICE) Imaging Note 17 syngo fourSight TEE View Note 18 syngo Mitral Valve Assessment (MVA) syngo fourSinght 4D imaging Note 19
syngo Arterial Health Package (AHP)
syngo Auto Left Heart (Auto LH) Technology
syngo Velocity Vector Imaging Technology
syngo Auto OB Measurements
- Contrast Agent Imaging Note 20
- Note 21 syngo Auto follicle
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Note 11
Note 12
Note 13
Note 14
Division Sign-Off - Office of in Vitro Diagnostic Devices
510(k) K123001
{12}------------------------------------------------
510(k) Number (if known):
CW2 Continuous Wave Doppler Transducer for use with:
ACUSON X700 Diagnostic Ultrasound Systems
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | P | | | | |
| | Abdominal | | | | P | | | | |
| | Intra-operative<br>(Note 6) | | | | P | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | P | | | | |
| | SmallOrgan<br>(Note 1) | | | | P | | | | |
| | Neonatal Cephalic | | | | P | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | | |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared K121699
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Dynamic TCE Technology
- SieClear Note 3
- Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5
- Note 6 For example: abdominal, vascular
- Note 7 Stress Echo Imaging
- Axius Edge Assisted Ejection Fraction Note 8 Note 9 Clarify Vascular Enhancement Technology
- Note 10 SieScape Panoramic Imaging
-
- Note 11 syngo Arterial Health Package (AHP)
Note 12 syngo Auto OB Measurements
syngo Auto Left Heart (Auto LH) Technology Note 13
- syngo Velocity Vector Imaging Technology Note 14
- CartoSound Communication Note 15
Note 16 Intracardiac Echocardiography (ICE) Imaging
- syngo fourSight TEE View Note 17
- Note 18 syngo Mitral Valve Assessment (MVA) syngo fourSinght 4D imaging
- Note 19 Note 20 Contrast Agent Imaging
- Note 21 syngo Auto follicie
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Division Sign-Off - Offfc Office of in Vitro Diagnostic Devices
510(k) K123001
{13}------------------------------------------------
510(k) Number (if known):
CW5 Continuous Wave Doppler Transducer for use with:
ACUSON X700 Diagnostic Ultrasound Systems
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1&3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | P | | | | |
| | Abdominal | | | | P | | | | |
| | Intra-operative<br>(Note 6) | | | | P | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | P | | | | |
| | SmallOrgan<br>(Note 1) | | | | P | | | | |
| | Neonatal Cephalic | | | | P | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | (Specify) | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | P | | | | |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared K121699
syngo Arterial Health Package (AHP) For example: breast, testes, thyroid, penis, prostate, etc. Note 11 Note 1 syngo Auto OB Measurements Note 2 Dynamic TCE Technology Note 12 syngo Auto Left Heart (Auto LH) Technology Note 3 SieClear Note 13 Note 4 Advanced SieClear Note 14 syngo Velocity Vector Imaging Technology Note 5 3-Scape 3D Imaging Note 15 CartoSound Communication Note 6 For example: abdominal, vascular Note 16 Intracardiac Echocardiography (ICE) Imaging Stress Echo Imaging Note 17 syngo fourSight TEE View Note 7 Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo Mitral Valve Assessment (MVA) Note 9 Clarify Vascular Enhancement Technology Note 19 syngo fourSinght 4D imaging Note 10 SieScape Panoramic Imaging Note 20 Contrast Agent Imaging syngo Auto follicle Note 21 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001
Page 9 of
{14}------------------------------------------------
510(k) Number (if known):
AcuNav 8F Intracardiac Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|---------------------|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1I& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared K121699
For example: breast, testes, thyroid, penis, prostate, etc. Note 11 syngo Arterial Health Package (AHP) Note 1 syngo Auto OB Measurements Dynamic TCE Technology Note 12 Note 2 syngo Auto Left Heart (Auto LH) Technology Note 13 Note 3 SieClear syngo Velocity Vector Imaging Technology Note 14 Advanced SieClear Note 4 CartoSound Communication Note 15 Note 5 3-Scape 3D Imaging Intracardiac Echocardiography (ICE) Imaging Note 16 Note 6 For example: abdominal, vascular syngo fourSight TEE View Note 17 Note 7 Stress Echo Imaging syngo Mitral Valve Assessment (MVA) Note 8 Axius Edge Assisted Ejection Fraction Note 18 syngo fourSinght 4D imaging Clarify Vascular Enhancement Technology Note 19 Note 9 SieScape Panoramic Imaging Note 20 Contrast Agent Imaging Note 10 Note 21 syngo Auto follicle (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) K123001
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
AcuNav 10F Intracardiac Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|---------------------|
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared K121699
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 2 Dynamic TCE Technology
- Note 3 SieClear
- Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5
- For example: abdominal, vascular Note 6
- Note 7 Stress Echo Imaging
- Axius Edge Assisted Ejection Fraction Note 8 Clarify Vascular Enhancement Technology
- Note 9 Note 10 SieScape Panoramic Imaging
- syngo Auto OB Measurements Note 12
- syngo Auto Left Heart (Auto LH) Technology Note 13 Note 14 syngo Velocity Vector Imaging Technology
syngo Arterial Health Package (AHP)
- Note 15 CartoSound Communication
- Note 16 Intracardiac Echocardiography (ICE) Imaging
- syngo fourSight TEE View Note 17
- Note 18 syngo Mitral Valve Assessment (MVA)
- Note 19 syngo fourSinght 4D imaging
- Contrast Agent Imaging Note 20
- syngo Auto follicle Note 21
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k) 123001
{16}------------------------------------------------
510(k) Number (if known):
V5Ms TEE Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems
Device Name: Intended Use:
iagnostic imaging or fluid flow analysis of the human body as
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|------------------------|
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC…
