(29 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and analysis packages.
No.
The device is described as a "Diagnostic Ultrasound System" intended for "clinical diagnosis purposes" and "acquiring harmonic ultrasound echo data and display[ing] it". It is used for imaging and analysis, not for treating conditions.
Yes
The device description explicitly states, "The ACUSON NX2TM Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound systems..." Additionally, the "Intended Use / Indications for Use" section mentions that analysis packages provide information "used for clinical diagnosis purposes."
No
The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound systems" and describes hardware components like a flat panel display and the ability to acquire ultrasound echo data, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ACUSON NX2TM ultrasound imaging system is a diagnostic imaging device that uses ultrasound waves to create images of internal anatomical structures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states applications like Cardiac, Fetal, Abdominal, etc., which are all based on imaging the body directly. While it provides measurements and analysis for clinical diagnosis, this is based on the ultrasound images, not on in vitro analysis of biological samples.
Therefore, the ACUSON NX2TM ultrasound imaging system falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ACUSON NX2™ ultrasound imaging system is intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal 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 in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the 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
IYN, IYO, ITX
Device Description
The ACUSON NX2TM Diagnostic Ultrasound System is a 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, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ, Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel), Musculoskeletal, Breast, Testes, Thyroid, Penis, Prostate, Neonatal Cephalic, Adult Cephalic.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
The device has 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 to applicable medical device safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 image of three human profiles facing to the 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
July 28, 2016
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K161787
Trade/Device Name: ACUSON NX2" Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 27, 2016 Received: June 29, 2016
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.
Michael D.'Hara
For
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) K161787
Device Name ACUSON NX2 Diagnostic Ultrasound System
Indications for Use (Describe)
The ACUSON NX2TM ultrasound imaging system is intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal 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 in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"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."
3
510(k) Number (if known):
ACUSON NX2™ Diagnostic Ultrasound System
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 | ||||||||
| (Tracks1I& 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Power | ||||||||
| Doppler | Combined | ||||||||
| (Specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9,11,13 | ||
| Abdominal | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9,13 | ||
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Fetal | Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9 | ||
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9 | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9,10 | |
| Trans-rectal | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9 | ||
| Trans-vaginal | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9,11, | ||
| Trans-urethral | |||||||||
| Trans-esoph. | |||||||||
| (non-Card.) | |||||||||
| Musculo-skel. | |||||||||
| (Convent.) | N | N | N | N | N | BMDC | Note 2,3,4,6,8,9, | ||
| Musculo-skel. | |||||||||
| (Superfic) | N | N | N | N | N | BMDC | Note 2,3,4,6,8,9 | ||
| Intra -vascular | |||||||||
| Other | |||||||||
| (Specify) | |||||||||
| Cardiac Adult | N | N | N | N | N | BMDC | Note 2,3,4,6,7,8,12 | ||
| Cardiac | Cardiac Pediatric | N | N | N | N | N | BMDC | Note 2,3,4,6,8,12 | |
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-Cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | BMDC | Note 2,3,4,6,8,9 | |
| 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
Note 8 Clarify Vascular Enhancement Technology
Note 9 SieScape Panoramic Imaging
Note 10 syngo Arterial Health Package (AHP) Note 11 syngo Auto OB Measurements
Note 12 syngo Auto Left Heart (Auto LH) Technology
Note 13 syngo fourSight 4D imaging
(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)
Page 2 of 9
4
510(k) Number (if known):
Device Name:
Intended Use:
CH5-2 Convex Array Transducer for use with: ACUSON NX2™ 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 2,3,4,5,6,8,9,11 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,6,8,9 | |||
| Intra-operative | ||||||||||
| (Note 6) | ||||||||||
| Intra-operative | ||||||||||
| (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,6,8,9 | ||
| 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 2,3,4,6,8,9 | ||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K152469
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Dynamic TCE Technology Note 2
Note 3 SieClear Note 4 Advanced SieClear
- Note 5 3-Scape 3D Imaging
For example: abdominal, vascular Note 6
Stress Echo Imaging Note 7
Clarify Vascular Enhancement Technology Note 8
SieScape Panoramic Imaging Note 9
Note 10 syngo Arterial Health Package (AHP)
syngo Auto OB Measurements Note 11 Note 12 syngo Auto Left Heart (Auto LH) Technology
Note 13 syngo fourSight 4D imaging
(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)_
Page 3 of 9
5
510(k) Number (if known):
Device Name: Intended Use:
VF10-5 Linear Array Transducer for use with:
ACUSON NX2™ 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 | ||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,6,8,9 | |||
| Intra-operative | ||||||||||
| (Note 6) | ||||||||||
| Intra-operative | ||||||||||
| (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Fetal | Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,6,8,9 | ||
| Imaging | ||||||||||
| & Other | SmallOrgan | |||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,6,8,9 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,6,8,9,10 | |||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. | ||||||||||
| (non-Card.) | ||||||||||
| Musculo-skel. | ||||||||||
| (Convent.) | P | P | P | P | P | BMDC | Note 2,3,4,6,8,9 | |||
| Musculo-skel. | ||||||||||
| (Superfic) | P | P | P | P | P | BMDC | Note 2,3,4,6,8,9 | |||
| 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 2,3,4,8,9 | ||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K152469
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
Note 8 Clarify Vascular Enhancement Technology
Note 9 SieScape Panoramic Imaging
Note 10 syngo Arterial Health Package (AHP)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Note 12
Note 13
syngo Auto OB Measurements
syngo fourSight 4D imaging
syngo Auto Left Heart (Auto LH) Technology
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 4 of 9
6
C5-2v Convex Array Transducer for use with:
510(k) Number (if known):
| Device Name: | | C5-2v Convex Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System | | | | | | | | |
|-----------------------------|-------------------------------|-----------------------------------------------------------------------------------------|---|-----|-----|------------------|------------------|-----------------------|-----------------------|--|
| 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 | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9,11 | |
| | Abdominal | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9 | |
| | Intra-operative
(Note 6) | | | | | | | | | |
| | Intra-operative
(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal
Imaging
& Other | Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,8,9 | |
| | 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 | N | N | N | N | N | N | BMDC | Note 2,3,4,6,8,9 | |
| | 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
- Note 5 3-Scape 3D Imaging
For example: abdominal, vascular Note 6
- Note 7 Stress Echo Imaging
- Clarify Vascular Enhancement Technology Note 8
Note 9 SieScape Panoramic Imaging
Note 10 syngo Arterial Health Package (AHP)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Note 12
Note 13
syngo Auto OB Measurements
syngo fourSight 4D imaging
syngo Auto Left Heart (Auto LH) Technology
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
7
510(k) Number (if known):
Device Name: Intended Use:
L10-5v Linear Array Transducer for use with:
ACUSON NX2™ 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 | |||||||||
| Abdominal | N | N | N | N | N | N | BMDC | Note 2,3,4,8,9 | |
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | N | N | N | N | N | N | BMDC | Note 2,3,4,8,9 |
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | N | N | N | N | N | N | BMDC | Note 2,3,4,8,9 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | N | N | N | N | N | N | BMDC | Note 2,3,4,8,9,10 | |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. | |||||||||
| (non-Card.) | |||||||||
| Musculo-skel. | |||||||||
| (Convent.) | N | N | N | N | N | N | BMDC | Note 2,3,4,8,9 | |
| Musculo-skel. | |||||||||
| (Superfic) | N | N | N | N | N | N | BMDC | Note 2,3,4,8,9 | |
| Intra-vascular | |||||||||
| Other | |||||||||
| (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | BMDC | Note 2,3,4,8,9 |
| Vessel | Other (Specify) |
N = new indication; P = previously cleared
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Advanced SieClear Note 4
- Note 5 3-Scape 3D Imaging
Note 6 For example: abdominal, vascular
Note 7 Stress Echo Imaging
Note 8 Clarify Vascular Enhancement Technology
Note 9 SieScape Panoramic Imaging syngo Arterial Health Package (AHP) Note 10
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Note 12 Note 13 syngo Auto OB Measurements
syngo fourSight 4D imaging
syngo Auto Left Heart (Auto LH) Technology
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 6 of 9
Dynamic TCE Technology Note 2 SieClear Note 3
8
510(k) Number (if known):
Device Name: Intended Use:
EC9-4 Convex Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation Other Specific Color Power Combined Other B M PWD CWD ( Track 1 (Tracks1I& 3) Doppler Doppler (Specify) (Specify) Only) Ophthalmic Ophthalmic P P P P P BMDC Fetal Note 2,3,4,5,6,8,9,11 Abdominal Intra-operative (Note 6) Intra-operative (Neuro) Laparoscopic Fetal Pediatric lmaging SmallOrgan P P P P P BMDC Note 2,3,4,5,8,9 & Other (Note 1) Neonatal Cephalic Adult Cephalic P Trans-rectal P P P P BMDC Note 2,3,4,5,6,8,9 P P P P P BMDC Note 2,3,4,5,6,8,9,11 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 K152469
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 3 SieClear Advanced SieClear Note 4
- 3-Scape 3D Imaging Note 5
- Note 6 For example: abdominal, vascular
- Note 7 Stress Echo Imaging
- Note 8 Clarify Vascular Enhancement Technology
Note 9 SieScape Panoramic Imaging syngo Arterial Health Package (AHP) Note 10
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Note 12
Note 13
syngo Auto OB Measurements
syngo fourSight 4D imaging
syngo Auto Left Heart (Auto LH) Technology
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 7 of 9
Dynamic TCE Technology Note 2
9
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name:
Intended Use:
P4-2 Phased Sector Array Transducer for use with: ACUSON NX2™ 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 | P | P | P | P | P | P | BMDC | Note 2,8 | |
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,8 | |
| Intra-operative | |||||||||
| (Note 6) | |||||||||
| Intra-operative | |||||||||
| (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Fetal | Pediatric | ||||||||
| Imaging | |||||||||
| & Other | SmallOrgan | ||||||||
| (Note 1) | P | P | P | P | P | P | BMDC | Note 2,8 | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2,8 | |
| 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 2,3,4,6,7,8,12 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,6, 8,12 |
| Intra-vascular | |||||||||
| (Cardiac) | |||||||||
| Trans-esophageal | |||||||||
| (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by K152469
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 Clarify Vascular Enhancement Technology SieScape Panoramic Imaging
- Note 9 Note 10 syngo Arterial Health Package (AHP)
syngo Auto OB Measurements Note 11
Note 12 syngo Auto Left Heart (Auto LH) Technology
Note 13 syngo fourSight 4D imaging
(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):
| 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 2,3,4,5,6,8,9,11,13 | ||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,6,8,9,13 | ||
| 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 | Cardiac Adult | ||||||||
| 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 K152469
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 Clarify Vascular Enhancement Technology
Note 9 SieScape Panoramic Imaging
Note 10 syngo Arterial Health Package (AHP)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Note 12
Note 13
syngo Auto OB Measurements
syngo fourSight 4D imaging
syngo Auto Left Heart (Auto LH) Technology
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 9 of 9
11
510(k) Summary
| Date: | May 14, 2016 | ||
|---|---|---|---|
| Submitter: | Siemens Medical Solutions USA, Inc., | ||
| Ultrasound Division | |||
| 685 East Middlefield Road | |||
| Mountain View, California 94043 | |||
| Manufacturing | |||
| Facility: | Siemens Healthcare Ltd. | ||
| 2nd -3rd floor, 143, Sunhwan-ro, | |||
| Jungwon-gu, Seongnam-si, Gyeonggi-do, | |||
| Republic of Korea | |||
| Contact Person: | Shelly Pearce | ||
| Tel: (650) 279-0134 | |||
| Device Name: | ACUSON NX2™ Diagnostic Ultrasound System | ||
| Common Name: | Diagnostic Ultrasound System with Accessories | ||
| Classification: | Regulatory Class: | II | |
| Review Category: | Tier II | ||
| Classification Panel: | Radiology | ||
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
A. Legally Marketed Predicate Devices
The ACUSON NX2™ Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products, the ACUSON X700™ Diagnostic Ultrasound System (K141846) and ACUSON NX3™ Diagnostic Ultrasound System (K152469).
12
B. Device Description
The ACUSON NX2TM Diagnostic Ultrasound System is a 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, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
C. Intended Use
The ACUSON NX2™ ultrasound imaging system is intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal 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 the 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 ACUSON NX2™ Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products, the ACUSON X700 ™ Diagnostic Ultrasound System (K141846), and ACUSON NX3 ™ Diagnostic Ultrasound System (K152469). 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 device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
13
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON NX2™ Diagnostic Ultrasound System 510(k) Submission
| Feature / Characteristic | Predicate Device
ACUSON X700™
(K141846) | Predicate Device
ACUSON NX3™
(K152469) | Submission Device
ACUSON NX2™ |
|----------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------|----------------------------------|
| Indications for Use: | | | |
| ■ Fetal Echo | √ | √ | √ |
| ■ Abdominal | √ | √ | √ |
| ■ Renal | √ | √ | √ |
| ■ Cerebrovascular | √ | √ | √ |
| ■ Orthopedics | √ | √ | √ |
| ■ Small Organ | √ | √ | √ |
| ■ Pediatric | √ | √ | √ |
| ■ Adult Cephalic | √ | √ | √ |
| ■ Cardiac (Adult) | √ | √ | √ |
| ■ Intracardiac | √ | - | - |
| ■ Trans-esophageal | √ | √ | √ |
| ■ Transrectal | √ | √ | √ |
| ■ Urolology | √ | √ | √ |
| ■ Transvaginal | √ | √ | √ |
| ■ Peripheral vessel | √ | √ | √ |
| ■ Musculo-skeletal (conventional) | √ | √ | √ |
| ■ Musculo-skeletal (superficial) | √ | √ | √ |
| ■ Emergency Medicine | √ | √ | √ |
| 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) | √ | √ | √ |
| ■ CWD (Continuous Wave
Doppler) | √ | - | - |
| ■ SCW (Steerable CW) | √ | √ | √ |
| Feature / Characteristic | Predicate Device
ACUSON X700™
(K141846) | Predicate Device
ACUSON NX3™
(K152469) | Submission Device
ACUSON NX2™ |
| ■ 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: | | | |
| ■ US Security (Virus Protection) | √ | √ | √ |
| ■ Multi-View Spatial Compounding
(SieClear) | √ | √ | √ |
| ■ Advanced *SieClear (*SieClear =
Multi-View Spatial Compounding) | √ | √ | √ |
| ■ DTCE (Dynamic Tissue Contrast
Enhancement) | √ | √ | √ |
| ■ TGO (Tissue Grayscale
Optimization) | √ | √ | √ |
| ■ HD Zoom | √ | √ | √ |
| ■ DICOM (3.0 connectivity, Worklist,
MPPS) | √ | √ | √ |
| ■ DICOM SR OB/GYN | √ | √ | √ |
| ■ DICOM SR Cardiac | √ | √ | √ |
| ■ DICOM SR Vascular | √ | √ | √ |
| ■ 3D Imaging (3-Scape) | √ | √ | √ |
| ■ 3D Measurements | √ | √ | √ |
| ■ 4D Basic Imaging (fourSight 4D) | √ | √ | √ |
| ■ Panoramic 2D Imaging | √ | √ | √ |
| ■ Syngo Auto OB | √ | √ | √ |
| ■ Stress Echo | √ | √ | √ |
| Vascular Enhancement (Clarify
VE) | √ | √ | √ |
| ■ VET (Pictogram) | √ | √ | √ |
| ■ Auto Left Heart | √ | √ | √ |
| ■ Syngo AHP (Arterial Health
Package) | √ | - | √ |
| ■ Monitor: FPD | √ (20" FPD) | √ (21.5" FPD) | √ (21.5" FPD) |
| ■ Wireless | √ | √ | √ |
14
Siemens Medical Solutions USA, Inc. Ultrasound Division
ACUSON NX2™ Diagnostic Ultrasound System 510(k) Submission
15
E. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:
- 트 UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 트 AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical 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
- 트 Safety and EMC Requirements for Medical Equipment
- IEC 60601-1-2
- IEC 60601-2-18
- ISO 10993-1 Biocompatibility
Patient contact materials, electrical and mechanical safety are unchanged from the predicate devices.
F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the ACUSON NX2™ Diagnostic Ultrasound Systems uses the same technology and principles as existing devices, clinical data is not required.
G. Summary
Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform to 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 Solutions USA, Inc. that the ACUSON NX2™ Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
The ACUSON NX2™ Diagnostic Ultrasound System is verified and validated according to the company's design control process.