(21 days)
Not Found
No
The document describes standard ultrasound imaging technology and post-processing techniques, with no mention of AI, ML, or related concepts.
No.
The device is used for diagnostic imaging and analysis, not for treatment. Its stated purpose is for clinical diagnosis and imaging aid.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "provide[s] information that is used for clinical diagnosis purposes." Furthermore, the "Device Description" section refers to the devices as "Diagnostic Ultrasound Systems."
No
The device is described as a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and explicitly mentions transmitting ultrasonic energy and performing post-processing of received echoes, indicating it includes hardware components for image acquisition and processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for ultrasound imaging and provides measurements and analysis packages that provide information used for clinical diagnosis purposes. This describes a medical imaging device used to visualize internal structures and provide data for a physician's diagnosis, not a device that performs tests on biological samples in vitro (outside the body).
- Device Description: The description details how the system acquires and processes ultrasound echo data to display images and information on a screen. This aligns with the function of an ultrasound imaging system.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue, etc.) or to detect the presence of specific substances or markers within those samples. IVDs are designed for these types of analyses.
The device is a diagnostic ultrasound system, which is a type of medical device used for diagnosis, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For ACUSON NX3
The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
For ACUSON NX3 Elite
ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts(Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
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. Note: This feature can 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 Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Siemens ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems 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, 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ - e.g. breast, testes, thyroid, penis, prostate), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal (Conventional and Superficial), Urology.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Since the ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2015
Siemens Medical Solutions USA, Inc., Ultrasound Division % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K152469
Trade/Device Name: ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 28, 2015 Received: August 31, 2015
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.
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.
1
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,
Robert Odlo
Robert Ochs, Ph.D. 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) K152469
Device Name
ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems
Indications for Use (Describe)
For ACUSON NX3
The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
For ACUSON NX3 Elite
ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
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. Note: This feature can 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 Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Number (if known):
Device Name: Intended Use:
ACUSON NX3 Elite™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other | |||||||||
| (Track1 | |||||||||
| Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,12,14 | |
| Abdominal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,15 | |
| Intra-operative | |||||||||
| (Note 6) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 |
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,17 | |
| Neonatal Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9 | |
| Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,11 | |
| Trans-rectal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | |
| Trans-vaginal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10,12,14,16 | |
| Trans-urethral | |||||||||
| Trans-esoph. | |||||||||
| (non-Card.) | |||||||||
| Musculo-skel. | |||||||||
| (Convent.) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,11 | |
| Musculo-skel. | |||||||||
| (Superfic) | N | N | N | N | N | N | BMDC | Note 2,3,4,9,10,11 | |
| Intra -vascular | |||||||||
| Other | |||||||||
| (Specify) | |||||||||
| Cardiac Adult | N | N | N | N | N | N | BMDC | Note 2,7,8,9,13, | |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,6,8,9,13 |
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | 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.
- Dynamic TCE Technology Note 2
- Note 3 SieClear
- Note 4 Advanced SieClear 3-Scape 3D Imaging
- Note 5 For example: abdominal, vascular Note 6
- Note 7 Stress Echo Imaging
Note 8 Axius Edge Assisted Ejection Fraction
Clarify Vascular Enhancement Technology Note 9
Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
Note 14 syngo fourSight 4D imaging
Contrast Agent Imaging (NX3 Elite only) Note 15
syngo Auto follicle Note 16
eSie Touch (NX3 Elite only) Note 17
(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)
5
510(k) Number (if known):
Device Name: Intended Use:
ACUSON NX3TM Diagnostic Ultrasound System
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 | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,12,14 | |||
| Abdominal | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | |||
| Intra-operative | ||||||||||
| (Note 6) | ||||||||||
| Intra-operative | ||||||||||
| (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | Pediatric | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | ||
| Imaging | ||||||||||
| & Other | SmallOrgan | |||||||||
| (Note 1) | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9 | ||
| Trans-rectal | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | |||
| Trans-vaginal | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10,12,16 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. | ||||||||||
| (non-Card.) | ||||||||||
| Musculo-skel. | ||||||||||
| (Convent.) | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | |||
| Musculo-skel. | ||||||||||
| (Superfic) | N | N | N | N | N | BMDC | Note 2,3,4,9,10 | |||
| Intra -vascular | ||||||||||
| Other | ||||||||||
| (Specify) | ||||||||||
| Cardiac Adult | N | N | N | N | N | BMDC | Note 2,7,8,9 | |||
| Cardiac | Cardiac Pediatric | N | N | N | N | N | BMDC | Note 2,7,8,9 | ||
| Intra-vascular | ||||||||||
| (Cardiac) | ||||||||||
| Trans-esophageal | ||||||||||
| (Cardiac) | ||||||||||
| Intra-Cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10 | ||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Dynamic TCE Technology
- Note 2 Note 3 SieClear
- Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5
- For example: abdominal, vascular Note 6
- Stress Echo Imaging Note 7 Axius Edge Assisted Ejection Fraction Note 8
- Note 9 Clarify Vascular Enhancement Technology
Note 10 SieScape Panoramic Imaging
- syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11
Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
Note 14 syngo fourSight 4D imaging
Contrast Agent Imaging (NX3 Elite only) Note 15
syngo Auto follicle Note 16
Note 17 eSie Touch (NX3 Elite 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)_
6
510(k) Number (if known):
CH5-2 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound Device Name: System Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Other | ||||||||||
| ( Track1 | ||||||||||
| Only) | Specific | |||||||||
| (Tracks1l& 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 2,3,4,5,6,9,10,15,16 | |||
| Intra-operative | ||||||||||
| (Note 6) | ||||||||||
| Intra-operative | ||||||||||
| (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10 | ||
| Imaging | ||||||||||
| & Other | 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 | |||||||||
| Intra-vascular | ||||||||||
| (Cardiac) | ||||||||||
| Trans-esophageal | ||||||||||
| (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10 | ||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K141846
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Dynamic TCE Technology Note 2
- SieClear Note 3 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 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
- syngo Auto follicle Note 17 eSie Touch (NX3 Elite only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11
7
510(k) Number (if known):
Device Name:
VF10-5 Linear Array Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System
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 | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,9,10,16 | |||
| Intra-operative | ||||||||||
| (Note 6) | ||||||||||
| Intra-operative | ||||||||||
| (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | ||||||||||
| Imaging | ||||||||||
| & Other | Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,9,10 | ||
| SmallOrgan | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,9,10,17 | |||
| Neonatal Cephalic | ||||||||||
| 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 | |||
| Musculo-skel. | ||||||||||
| (Superfic) | P | P | P | P | P | BMDC | Note 2,3,4,9,10 | |||
| Intra-vascular | ||||||||||
| Other | ||||||||||
| (Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Intra-vascular | ||||||||||
| (Cardiac) | ||||||||||
| Trans-esophageal | ||||||||||
| (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
N = new indication; P = previously cleared K141846
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Dynamic TCE Technology Note 2
- Note 3 SieClear 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) (NX3 Elite only) Note 12 syngo Auto OB Measurements
syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 13
-
syngo fourSight 4D imaging Note 14
Contrast Agent Imaging (NX3 Elite only) Note 15 -
Note 16 syngo Auto follicle
-
Note 17 eSie Touch (NX3 Elite 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)
8
510(k) Number (if known):
Device Name:
VF12-4 Linear Array Transducer for use with:
VF12-4 Linear Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System 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 | |||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,16 | |
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10,17 | |
| Neonatal Cephalic |
- NX3 Elite only | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| | 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 |
| | Musculo-skel.
(Superfic) | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| | Intra-vascular | | | | | | | | |
| | Other
(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular
(Cardiac) | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,9,10 |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared by K141846
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Dynamic TCE Technology Note 2
-
Note 3 SieClear
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
- Clarify Vascular Enhancement Technology Note 9
SieScape Panoramic Imaging Note 10
Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
syngo fourSight 4D imaging Note 14
Contrast Agent Imaging (NX3 Elite only) Note 15 Note 16 syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite 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)_
9
510(k) Number (if known):
Device Name:
Intended Use:
EC10-5w Convex Array Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System 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 | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,9,10,12 | |
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Pediatric | ||||||||
| SmallOrgan | |||||||||
| (Note 1) | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10 | |
| Neonatal Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6, 9,10 | |
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10 | |
| Trans-vaginal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,9,10,12,16 | |
| 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 | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Dynamic TCE Technology Note 2 SieClear Note 3
- Advanced SieClear Note 4
- Note 5 3-Scape 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 Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 12 syngo Auto OB Measurements
syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 13
Note 14 syngo fourSight 4D imaging
Note 15 Contrast Agent Imaging (NX3 Elite only)
Note 16 syngo Auto follicle
Note 17 eSie Touch (NX3 Elite 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)
10
510(k) Number (if known):
Device Name:
EC9-4 Convex Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound
Intended Use:
System 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 | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,12 | ||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Pediatric | ||||||||
| SmallOrgan | |||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,9,10 | ||
| Neonatal Cephalic |
- NX3 Elite Only | P | P | P | | P | P | BMDC | Note 2,3,4,5,6, 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 2,3,4,5,9,10,12,16 |
| | 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 by K121699
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Dynamic TCE Technology
- Note 2 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
-
SieScape Panoramic Imaging Note 10
Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 12 syngo Auto OB Measurements Note 13
syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only) Note 14 syngo fourSight 4D imaging
- Contrast Agent Imaging (NX3 Elite only) Note 15
- syngo Auto follicle Note 16
- Note 17 eSie Touch (NX3 Elite 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)_
11
510(k) Number (if known):
CW2 Continuous Wave Doppler Transducer for use with: Device Name: ACUSON NX3 Elite™ Diagnostic Ultrasound System
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 | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Pediatric | ||||||||
| 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 | ||||||||
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by K141846
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
- Stress Echo Imaging Note 7
- Axius Edge Assisted Ejection Fraction Note 8
- Clarify Vascular Enhancement Technology Note 9
- SieScape Panoramic Imaging Note 10
syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11
- Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
- syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
12
510(k) Number (if known):
CW5 Continuous Wave Doppler Transducer for use with: Device Name: ACUSON NX3 Elite™ Diagnostic Ultrasound System
Intended Use:
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 | |||||||||
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Pediatric | ||||||||
| SmallOrgan | |||||||||
| (Note 1) | |||||||||
| Neonatal Cephalic | |||||||||
| 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 | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by K141846
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 2 Dynamic TCE Technology
- Note 3 SieClear Advanced SieClear Note 4
- 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
- SieScape Panoramic Imaging Note 10
Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
- Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
- syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
13
510(k) Number (if known):
Device Name:
Intended Use:
P4-2 Phased Sector Array Transducer for use with:
P4-2 Phased Sector Array Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound System
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 | BMDC | Note 2,9 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,9,16 | |||
| Intra-operative | ||||||||||
| (Note 6) | ||||||||||
| Intra-operative | ||||||||||
| (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | Pediatric | P | P | P | P | P | BMDC | Note 2,9 | ||
| Imaging | ||||||||||
| & Other | SmallOrgan | |||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,9 | |||
| Neonatal Cephalic |
- NX3 Elite Only | P | P | P | | P | P | BMDC | Note 2,9 | |
| | Adult Cephalic | P | P | P | | P | P | BMDC | Note 2,9 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.
(non-Card.) | | | | | | | | | |
| | Musculo-skel.
(Convent.) | | | | | | | | | |
| | Musculo-skel.
(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other
(Specify) | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2,7,8,9,13 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,7,8,9,13 | |
| | Intra-vascular
(Cardiac) | | | | | | | | | |
| | Trans-esophageal
(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | |
N = new indication; P = previously cleared by 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
- Note 8 Axius Edge Assisted Ejection Fraction
- Note 9 Clarify Vascular Enhancement Technology
- Note 10 SieScape Panoramic Imaging
- Note 12 syngo Auto OB Measurements
- Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Contrast Agent Imaging (NX3 Elite only) Note 15
- Note 16 syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite 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)_
syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11
14
510(k) Number (if known):
Device Name:
VF16-5 Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Other | |||||||||
| ( Track 1 | |||||||||
| Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,9,10,16,17 | ||
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,9,10 | |
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,9,10,17 | ||
| Neonatal Cephalic | |||||||||
| 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 2,3,4,9,10,17 | ||
| Musculo-skel. | |||||||||
| (Superfic) | P | P | P | P | P | BMDC | Note 2,3,4,9,10,17 | ||
| 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 by K141846
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 Note 9 Clarify Vascular Enhancement Technology
Note 10 SieScape Panoramic Imaging Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 14 syngo fourSight 4D imaging
Contrast Agent Imaging (NX3 Elite only) Note 15 Note 16 syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
15
510(k) Number (if known):
Device Name: Intended Use:
VF13-5sp Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System
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 | |||||||||
| Intra-operative | |||||||||
| (Note 6) | P | P | P | P | P | BMDC | Note 2,3,4,9,10,16,17 | ||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,9,10 | |
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,9,10,17 | ||
| Neonatal Cephalic | |||||||||
| 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 2,3,4,9,10,17 | ||
| Musculo-skel. | |||||||||
| (Superfic) | P | P | P | P | P | BMDC | Note 2,3,4,9,10,17 | ||
| Intra-vascular | |||||||||
| Other | |||||||||
| (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| (Note 1) | P | P | P | P | P | Note 2,3,4,9 | |||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K121699
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 Note 6 For example: abdominal, vascular
- Note 7 Stress Echo Imaging
- Axius Edge Assisted Ejection Fraction Note 8
- Clarify Vascular Enhancement Technology Note 9
- Note 10 SieScape Panoramic Imaging
Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only)
- Note 16 syngo Auto follicle Note 17 eSie Touch (NX3 Elite only)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Number (if known):
C8F3 Transducer for use with:
ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound Device Name: System 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 | P | BMDC | Note 2,3,4,5,6,9,10,12,14 | |
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,14,16 | |
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Pediatric | ||||||||
| 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 | ||||||||
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K141846
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Dynamic TCE Technology Note 2
- SieClear Note 3 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 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
- Note 14 syngo fourSight 4D imaging
- Note 15 Contrast Agent Imaging (NX3 Elite only) Note 16
- syngo Auto follicle Note 17 eSie Touch (NX3 Elite only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
syngo Arterial Health Package (AHP) (NX3 Elite only) Note 11
17
510(k) Number (if known):
Device Name:
C8-5 Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System
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 | |||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,16 | ||
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10 | |
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10 | ||
| Adult Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10 | ||
| 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 2,3,4,5,6,9,10 | |
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by K141846
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 2 Dynamic TCE Technology
- Note 3 SieClear
Note 4 Advanced SieClear
- Note 5 3-Scape 3D Imaging 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 Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
Note 14 syngo fourSight 4D imaging
-
Contrast Agent Imaging (NX3 Elite only) Note 15
Note 16 syngo Auto follicle -
Note 17 eSie Touch (NX3 Elite only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
18
510(k) Number (if known):
Device Name:
P8-4 Transducer for use with: ACUSON NX3 Elite™ Diagnostic Ultrasound System
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 | |||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10,16 | |
| 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 |
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | |||||||||
| Neonatal Cephalic | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,9,10 | |
| 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 2,3,4,5,6,9,10 | |
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K141846
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- 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 Note 9 Clarify Vascular Enhancement Technology
Note 10 SieScape Panoramic Imaging Note 11 syngo Arterial Health Package (AHP) (NX3 Elite only)
Note 12 syngo Auto OB Measurements
Note 13 syngo Auto Left Heart (Auto LH) Technology (NX3 Elite only)
Note 14 syngo fourSight 4D imaging
- Contrast Agent Imaging (NX3 Elite only) Note 15
- Note 16 syngo Auto follicle
- Note 17 eSie Touch (NX3 Elite only)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
19
510(k) Summarv Prepared September 10, 2015
| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043 |
| ---------- | ------------------------------------------------------------------------------------------------------------------------- |
|---|
Manufacturing Facility
| SIEMENS LTD SEOUL
2nd -30 floor, 143, Sunhwan-ro,
Jungwon-gu, Seongnam-si, Gyeonggi-do,
| Republic of Korea |
|---|
| Contact Person: | Shelly Pearce | |
|---|---|---|
| Telephone: | (650) 279-0134 | |
| Fax: | (650) 694-5580 | |
| Device Name: | ACUSON NX2 EliteTM Diagnostic Ultrasound |
- ACUSON NX3 Elite™ Diagnostic Ultrasound System Device Name: ACUSON NX3™ Diagnostic Ultrasound System
- Common Name: Diagnostic Ultrasound System with Accessories
Classification:
Regulatory Class: 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 |
A. Legally Marketed Predicate Devices
The ACUSON NX3 Elite™ Diagnostic Ultrasound System and ACUSON NX3™ Diagnostic Ultrasound System are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current product. the ACUSON X700™ Diagnostic Ultrasound System (K141846) and ACUSON X300™ Diagnostic Ultrasound System (K121699).
B. Device Description:
The Siemens ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems 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, 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.
20
C. Intended Use
For ACUSON NX3
The ACUSON NX3 ultrasound imaging system, is intended for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts(Small Organ), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
For ACUSON NX3 Elite
ACUSON NX3 Elite ultrasound imaging systems are intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts(Small Organ including intra-operative), Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular(including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.
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. Note: This feature can 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 Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine."
D. Substantial Equivalence
The Siemens ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to our current products, the Siemens ACUSON X700™ Diagnostic Ultrasound System (K141846), and ACUSON X300 ™ Diagnostic Ultrasound System (K121699). All systems transmit ultrasonic energy into patients, and 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 devices are substantially equivalent to the predicate with regard to both intended use and technological characteristics.
21
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems 510(k) Submission
| Feature /
Characteristic | Predicate
Device
ACUSON
X300TM
(K121699) | Predicate
Device
ACUSON
X700TM
(K141846) | Submission
Device
ACUSON
NX3TM | Submission
Device
ACUSON NX3
EliteTM | |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|-----------------------------------------|-----------------------------------------------|---|
| | Indications for Use: | | | | |
| | Fetal Echo | √ | √ | √ | √ |
| | Abdominal | √ | √ | √ | √ |
| | Intra-operative | √ | √ | - | √ |
| | Neonatal
Cephalic | √ | √ | - | √ |
| | Small
Organ(parts) | √ | √ | √ | √ |
| | Pediatric | √ | √ | √ | √ |
| | Adult Cephalic
(Trans-cranial) | √ | √ | √ | √ |
| | Cardiac (Adult) | √ | √ | √ | √ |
| | Cardiac
(Pediatric) | √ | √ | - | √ |
| | Intracardiac | √ | √ | - | - |
| | Trans-
esophageal | √ | √ | - | - |
| | Trans-rectal | √ | √ | √ | √ |
| | Trans-vaginal | √ | √ | √ | √ |
| | Peripheral vessel | √ | √ | √ | √ |
| | Musculo-skeletal
(conventional) | √ | √ | √ | √ |
| | Musculo-skeletal
(superficial) | √ | √ | √ | √ |
| Center Frequencies
Supported: | | | | | |
| | 2.0 MHz | √ | √ | √ | √ |
| | 2.5 MHz | √ | √ | √ | √ |
| | 3.0 MHz | √ | √ | √ | √ |
| | 3.5 MHz | √ | √ | √ | √ |
| | 4.0 MHz | √ | √ | √ | √ |
| | 5.0 MHz | √ | √ | √ | √ |
| | 5.5 MHz | √ | √ | √ | √ |
| | 6.0 MHz | √ | √ | √ | √ |
| | 6.5 MHz | √ | √ | √ | √ |
| | 7.5 MHz | √ | √ | √ | √ |
| | 8.0 MHz | √ | √ | √ | √ |
| | 9.0 MHz | √ | √ | √ | √ |
| | 10.0 MHz | √ | √ | √ | √ |
| | 11.0 MHz | √ | √ | √ | √ |
| | 12.0 MHz | - | √ | - | √ |
| | 13.0 MHz | - | √ | - | √ |
| | Modes: | | | | |
| | B | √ | √ | √ | √ |
| | M | √ | √ | √ | √ |
| | PWD (Pulsed
Wave Doppler) | √ | √ | √ | √ |
| Feature /
Characteristic | Predicate
Device ACUSON
X300™
(K121699) | Predicate
Device ACUSON
X700™
(K141846) | Submission
Device ACUSON
NX3™ | Submission
Device ACUSON NX3
Elite™ | |
| ■ CWD (Continuous Wave
Doppler) | √ | √ | - | √ | |
| ■ SCW (Steerable
CW) | √ | √ | √ | √ | |
| ■ CD (Color
Doppler) | √ | √ | √ | √ | |
| ■ Amplitude
Doppler
(Power Doppler) | √ | √ | √ | √ | |
| ■ Directional
Power Doppler | √ | √ | √ | √ | |
| ■ Combined (BM,
BC, BCM, BCD) | √ | √ | √ | √ | |
| ■ THI (Tissue
Harmonic Imaging) | √ | √ | √ | √ | |
| ■ AMM (Anatomical M-
mode) | √ | √ | √ | √ | |
| ■ Doppler Tissue
Image (Color, PW) | √ | √ | √ | √ | |
| ■ M-THI | √ | √ | √ | √ | |
| Features: | | | | | |
| ■ Multi-View Spatial
Compounding
(SieClear) | √ | √ | √ | √ | |
| ■ Advanced
SieClear | - | √ | √ | √ | |
| ■ DTCE (Dynamic Tissue
Contrast Enhancement) | √ | √ | √ | √ | |
| ■ Tissue Grayscale
Optimization
(TGO) | √ | √ | √ | √ | |
| ■ Dual-Beam
Processing | √ | √ | √ | √ | |
| ■ Quad-Beam
Processing | √ | √ | √ | √ | |
| ■ Clip Capture | √ | √ | √ | √ | |
| ■ 3D Imaging (3-
Scape) | √ | √ | √ | √ | |
| ■ 3D
Measurements | √ | √ | √ | √ | |
| ■ 4D Basic
Imaging (fourSight
4D) | √ | √ | √ | √ | |
| ■ Panoramic 2D
Imaging
(SieScape) | √ | √ | √ | √ | |
| ■ Syngo Auto OB | √ | √ | √ | √ | |
| ■ Syngo Auto
Follicle | - | √ | √ | √ | |
| Feature /
Characteristic | Predicate
Device
ACUSON
X300TM
(K121699) | Predicate
Device
ACUSON
X700TM
(K141846) | Submission
Device
ACUSON
NX3TM | Submission
Device
ACUSON NX3
EliteTM | |
| Cardiac Imaging
physiological
signal display
multiplane TEE
fourSight TEE
Imaging | √ | √ | - | - | |
| Stress Echo | √ | √ | √ | √ | |
| Vascular
Enhancement
(Clarify VE) | √ | √ | √ | √ | |
| Syngo VVI
(Velocity Vector
Image) | √ | √ | - | - | |
| Auto Left Heart | √ | √ | - | √ | |
| Axius EF | √ | √ | √ | √ | |
| Syngo AHP | √ | √ | - | √ | |
| Contrast Agent
Image | √ | √ | - | √ | |
| DIMAQ | √ | √ | √ | √ | |
| Multiple
Frequency
Imaging(MultiHertz) | √ | √ | √ | √ | |
| syngo Mitral
Valve
Assessments
(MVA) | √ | √ | - | - | |
| Intracardiac
Echocardiography
(ICE) Imaging | √ | √ | - | - | |
| Digital
Architecture | √ | √ | √ | √ | |
| Fully integrated
DICOM | √ | √ | √ | √ | |
| CARTOSOUNDTM Communication | √ | √ | - | - | |
| Wireless | √ | √ | √ | √ | |
| eSie Touch | - | √ | - | √ | |
| Monitor: FPD | (17" FPD) | √ (20" FPD) | √ (21.5" FPD) | √ (21.5" FPD) | |
| # Channels | 128 | 128 | 64 | 64 | |
| Output Display
Standard
(Track 3) | √ | √ | √ | √ | |
| Patient Contact
Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | |
22
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems 510(k) Submission
23
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems 510(k) Submission
24
E. A brief discussion of nonclinical tests submitted, referenced, or relied on in
the 510(k) for a determination of substantial equivalence
The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform with applicable medical device safety standards. The systems comply with the following voluntary standards:
- UL 60601-1, Safety Requirements for Medical Equipment .
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical 트 Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound ■
- IEC 62359, Test methods for the determination of thermal and mechanical indices
- 93/42/EEC Medical Devices Directive
- I Safety and EMC Requirements for Medical Equipment
- IEC 60601-1 .
- . IEC 60601-1-2
- IEC 60601-2-18 .
- IEC 60601-1-6
- IEC 62366 ■
- ISO 10993-1 Biocompatibility .
F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON NX3 Elite™ and ACUSON NX3™ Diagnostic Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required.
G. Summary
Intended uses and other kev features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The products are designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the ACUSON NX3 Elite™ and ACUSON NX3 ™ Diagnostic Ultrasound Systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
The ACUSON NX3 Elite™ and ACUSON NX3 ™ Diagnostic Ultrasound Systems are verified and validated according to the company's design control process.