← Product Code [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN) · K141846
# ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM (K141846)
_Siemens Medical Solutions USA, Inc. · IYN · Aug 7, 2014 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K141846
## Device Facts
- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [IYN](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN.md)
- **Decision Date:** Aug 7, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1550
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Pediatric, 3rd-Party Reviewed
## Intended Use
The Siemens ACUSON X700™ and X600™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, 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 and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal 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
Mobile, software-controlled diagnostic ultrasound systems; acquire harmonic ultrasound echo data; display in B-Mode, PW/CW Doppler, Color Doppler, Color M-mode, Tissue Doppler, Amplitude Doppler, 3D/4D imaging. Used in clinical settings by healthcare professionals. Provides anatomical measurements and analysis packages (e.g., Arterial Health Package for Intima Media Thickness, Auto OB, Auto Left Heart, Velocity Vector Imaging). Output displayed on flat panel monitor; assists clinicians in diagnosis and patient communication regarding cardiovascular health. Benefits include non-invasive visualization of anatomy and physiology, including intracardiac/intraluminal structures via specialized catheters.
## Clinical Evidence
Bench testing only. No clinical data required as the systems utilize the same technology and principles as existing, legally marketed predicate devices.
## Technological Characteristics
Mobile ultrasound system; digital architecture; 128-channel processing; supports multiple center frequencies (2.0-12.0 MHz). Patient contact materials tested to ISO 10993-1. Safety compliance: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1. Connectivity: DICOM, wireless. Software-based analysis packages (e.g., AHP, Auto OB, Auto LH).
## 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 X700 ([K123001](/device/K123001.md))
- ACUSON S2000 ([K112596](/device/K112596.md))
- ACUSON X300 ([K121699](/device/K121699.md))
- ACUSON S1000/S2000/S3000 ([K132804](/device/K132804.md))
## Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25th Street NW BUFFALO MN 55313
Re: K141846
Trade/Device Name: Acuson X700™ and Acuson X600™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: July 8, 2014 Received: July 9, 2014
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the Acuson X700 and Acuson X600 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 4C1 | AcuNav 10F | C6F2 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------|
| VF10-5 | V5Ms | C8F3 |
| VF12-4 | 4V1c | EV9F3 |
| EC9-4w | C7F2 | C8-5 |
| 6C2 | EV9F4 | P8-4 |
| CW2 | SoundStar 10F | MC9-4 |
| ું જિલ્લાના એક એવા ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પાદની ખેત-ઉપયોગના મધ્યમાં આવેલું એક ગામનાં મુખ્યત્વે તેમ જ દૂધની | SoundStar eco 10F | CH5-2 |
| AcuNav 8F | VF16-5 | C6-2 |
| SoundStar eco 8F | | |
{1}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.f)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known): K141846
ACUSON X700™ and X600 ™ Diagnostic Ultrasound System Device Name:
Indications For Use:
The Siemens ACUSON X700™ and X600 ™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, 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 and Soundstar Ultrsound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (21 CFG 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
FOR FDA USE ONLY
FDA
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
510(k) Number (if known): K141846
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
( Track1
Only) | Specific
(Tracks11& 3) | | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(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 2,3,4,5,6,9,10,11,12,20,22 |
| | Intra-operative
(Note 6) | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10 |
| | Intra-operative
(Neuro) | | | | | | | | | Note 2,3,4,5,6,9,10 |
| | Laparoscopic | | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| | SmallOrgan
(Note 1) | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11,19, 22 |
| | Neonatal Cephalic | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| | Adult Cephalic | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| | Trans-rectal | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,19 |
| | Trans-vaginal | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,9,10,12,19,21 |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11,22 |
| | Musculo-skel.
(Superfic) | | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11,22 |
| | Intra -vascular | | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,15,16 |
| | Other
(Specify) | | | | | | | | | |
| Cardiac | Cardiac Adult | | P | P | P | P | P | P | BMDC | Note 2,7,8,9, 13,14,15,16,17,18,19 |
| | Cardiac Pediatric | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,8,9,10,13,14,15,16 |
| | Intra-vascular
(Cardiac) | | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,15,16 |
| | Trans-esophageal
(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
Vessel | Peripheral vessel | | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| | 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 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
- Note 9 Clarify Vascular Enhancement Technology
Note 10 SieScape Panoramic Imaging
- 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 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
- Note 20 Contrast Agent Imaging
- Note 21 syngo Auto follicle (X700 only)
- Note 22 eSie Touch (X700 only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k) K141846
Page 2 of 28
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510(k) Number (if known): K141846
ACUSON X600 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
( Track1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,12,19 |
| | Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11,12,20 |
| | Intra-operative
(Note 6) | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| Imaging
& Other | SmallOrgan
(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 2,3,4,5,6,9,10,11 |
| | Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| | Trans-rectal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,19 |
| | Trans-vaginal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,9,10,12,19 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| | Musculo-skel.
(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
(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 2,3,4,5,6,8,9,10,13,14,15,16 |
| | Intra-vascular
(Cardiac) | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,15,16 |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,11 |
| 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
- Advanced SieClear Note 4
- Note 5 3-Scape 3D Imaging For example: abdominal, vascular Note 6
- 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)
syngo Auto OB Measurements Note 12
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
syngo fourSight TEE View Note 17 Note 18 syngo Mitral Valve Assessment (MVA)
- Note 19 syngo fourSinght 4D imaging
- Note 20 Contrast Agent Imaging
- Note 21 syngo Auto follicle (X700 only)
- Note 22 eSie Touch (X700 only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k) K141846
Page 3 of 28
{5}------------------------------------------------
510(k) Number (if known): K141846
Device Name:
4C1 Curved Array Transducer for use with:
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
( Track 1
Only) | Specific
(Tracks11& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(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
(Note 6) | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | | | | | |
| Imaging
& Other | SmallOrgan
(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.
(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 | P | P | P | P | P | P | BMDC | Note 2,3,4,6,9,10 |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared
| 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 |
| 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 | 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 |
| | | Note 21 | syngo Auto follicle (X700 only) |
| | | Note 22 | eSie Touch (X700 only) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_K141846
Page 4 of 28
{6}------------------------------------------------
510(k) Number (if known): K141846
Device Name:
VF10-5 Linear Array Transducer for use with:
Intended Use:
ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|-----------------------|
| Other
( Track 1
Only) | Specific
(Tracks1I& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Intra-operative
(Note 6) | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 |
| Imaging
& Other | SmallOrgan
(Note 1) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11,22 |
| | 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.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Musculo-skel.
(Superfic) | P | P | P | | P | P | BMDC | Note 2,3,4,9,10,11 |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | 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-Scane 3D Imaging
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
Note 8 Axius Edge Assisted Ejection Fraction
Note 9 Clarify Vascular Enhancement Technology
Note 10 SieScape Panoramic Imaging
- syngo Arterial Health Package (AHP) Note 11 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
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 Note 20 Contrast Agent Imaging
Note 21 syngo Auto follicle (X700 only)
Note 22 eSie Touch (X700 only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846
Page 5 of 28
{7}------------------------------------------------
510(k) Number (if known): K141846
Device Name:
VF12-4 Linear Array Transducer for use with:
Intended Use:
ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|-----------------------|--|
| Other
( Track 1
Only) | Specific
(Tracks1 & 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Intra-operative
(Note 6) | | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | - | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 | |
| Imaging
& Other | SmallOrgan
(Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11,22 | |
| | Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Musculo-skel.
(Superfic) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,11 | |
| | Intra-vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | 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. |
|--------|-------------------------------------------------------------|
| TO | |
- 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
- Note 8 Axius Edge Assisted Ejection Fraction Note 9 Clarify Vascular Enhancement Technology
- Note 10 SieScape Panoramic Imaging
-
- syngo Arterial Health Package (AHP) Note 11 Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology
- Note 14 syngo Velocity Vector Imaging Technology
- CartoSound Communication Note 15
Intracardiac Echocardiography (ICE) Imaging Note 16
- Note 17 syngo fourSight TEE View syngo Mitral Valve Assessment (MVA)
- Note 18
- Note 19 syngo fourSinght 4D imaging Note 20
- Contrast Agent Imaging
- Note 21 syngo Auto follicle (X700 only) Note 22 eSie Touch (X700 only)
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_K141846
Page 6 of 28
{8}------------------------------------------------
510(k) Number (if known): K141846
Device Name:
EC9-4w Convex Array Transducer for use with:
Intended Use:
ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|----------------------------|
| Other
(Track1
Only) | Specific
(Tracks1I& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10,12, 21 |
| | Abdominal | | | | | | | | |
| | Intra-operative
(Note 6) | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | | | | | |
| Imaging
& Other | SmallOrgan
(Note 1) | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10 |
| | Neonatal Cephalic | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10 |
| | Trans-vaginal | P | P | P | | P | P | BMDC | Note 2,3,4,5,9,10,12, 21 |
| | 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 | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared
| 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 |
| 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 | 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 |
| | | Note 21 | syngo Auto follicle (X700 only) |
| | | Note 22 | eSie Touch (X700 only) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_K141846
Page 7 of 28
{9}------------------------------------------------
510(k) Number (if known): K141846
| 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
( Track 1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | | P | P | BMDC | Note 2,3,4,5,6,9,10,12 | | |
| | Abdominal | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| | Intra-operative
(Note 6) | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| | Intra-operative
(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| | SmallOrgan
(Note 1) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| | Intra-vascular
(Cardiac) | | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | BMDC | Note 2,3,4,6,9,10 | | |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared
| Note 1 | For example: breast, testes, thyroid, penis, prostate, etc. | Note 11 | syngo Arterial |
|---------|-------------------------------------------------------------|---------|-------------------|
| Note 2 | Dynamic TCE Technology | Note 12 | syngo Auto OB |
| Note 3 | SieClear | Note 13 | syngo Auto Left |
| Note 4 | Advanced SieClear | Note 14 | syngo Velocity |
| Note 5 | 3-Scape 3D Imaging | Note 15 | CartoSound Co |
| Note 6 | For example: abdominal, vascular | Note 16 | Intracardiac Ec |
| Note 7 | Stress Echo Imaging | Note 17 | syngo fourSight |
| Note 8 | Axius Edge Assisted Ejection Fraction | Note 18 | syngo Mitral Va |
| Note 9 | Clarify Vascular Enhancement Technology | Note 19 | syngo fourSing |
| Note 10 | SieScape Panoramic Imaging | Note 20 | Contrast Agent |
| | | Note 21 | syngo Auto follic |
| | | Note 22 | eSie Touch (X7 |
lealth Package (AHP)
lote 12 syngo Auto OB Measurements
Measurements
t Heart (Auto LH) Technology
Vector Imaging Technology
ommunication
hocardiography (ICE) Imaging TEE View
lve Assessment (MVA)
ht 4D imaging
Note 20 Contrast Agent Imaging
t Imaging
icle (X700 only)
- 00 only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
# 510(k)_K141846
Page 8 of 28
{10}------------------------------------------------
510(k) Number (if known): K141846
| Device Name: | |
|--------------|--|
|--------------|--|
CW2 Continuous Wave Doppler Transducer for use with:
Intended Use:
ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------|
| Other
( Track1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | P | | | | |
| | Abdominal | | | | P | | | | |
| | Intra-operative
(Note 6) | | | | P | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | | | | P | | | | |
| Imaging
& Other | SmallOrgan
(Note 1) | | | | P | | | | |
| | Neonatal Cephalic | | | | P | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | |
| | Intra-vascular
Other | | | | | | | | |
| | (Specify) | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | P | | | | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared
| Note 1
Note 2
Note 3
Note 4
Note 5
Note 6
Note 7
Note 8
Note 9
Note 10 | For example: breast, testes, thyroid, penis, prostate, etc.
Dynamic TCE Technology
SieClear
Advanced SieClear
3-Scape 3D Imaging
For example: abdominal, vascular
Stress Echo Imaging
Axius Edge Assisted Ejection Fraction
Clarify Vascular Enhancement Technology
SieScape Panoramic Imaging | Note 11
Note 12
Note 13
Note 14
Note 15
Note 16
Note 17
Note 18
Note 19
Note 20
Note 21
Note 22 | syngo Arterial Health Package (AHP)
syngo Auto OB Measurements
syngo Auto Left Heart (Auto LH) Technology
syngo Velocity Vector Imaging Technology
CartoSound Communication
Intracardiac Echocardiography (ICE) Imaging
syngo fourSight TEE View
syngo Mitral Valve Assessment (MVA)
syngo fourSinght 4D imaging
Contrast Agent Imaging
syngo Auto follicle (X700 only)
eSie Touch (X700 only) |
|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846
Page 9 of 28
{11}------------------------------------------------
510(k) Number (if known): K141846
Device Name:
CW5 Continuous Wave Doppler Transducer for use with: ACUSON X700 Diagnostic Ultrasound Systems / ACUSON X600 Diagnostic Ultrasound Systems
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|--------------------|
| Other
( Track 1
Only) | Specific
(Tracks1& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal
Imaging
& Other | Fetal | | | | P | | | | |
| | Abdominal | | | | P | | | | |
| | Intra-operative
(Note 6) | | | | P | | | | |
| | Intra-operative
(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | P | | | | |
| | SmallOrgan
(Note 1) | | | | P | | | | |
| | Neonatal Cephalic | | | | P | | | | |
| | Adult Cephalic | | | | P | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | P | | | | |
| | Cardiac Pediatric | | | | P | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | P | | | | |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k) K141846
Page 10 of 28
{12}------------------------------------------------
510(k) Number (if known): K141846
| Device Name: | AcuNav 8F 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
( Track1
Only) | Specific
(Tracks1I& 3) | B | M | PWD | CWD | Color
Doppler | Power
Doppler | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| Fetal
Imaging
& Other | Intra-operative
(Note 6) | | | | | | |…
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K141846](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IYN/K141846)
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