ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
Device Facts
| Record ID | K173981 |
|---|---|
| Device Name | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System |
| Applicant | Siemens Medical Solutions USA, Inc. Ultrasound Group |
| Product Code | IYN · Radiology |
| Decision Date | Feb 2, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Adult Cephalic, 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."
Device Story
Mobile, software-controlled diagnostic ultrasound system; acquires harmonic ultrasound echo data via transducers; displays images in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Tissue Doppler, and 3D/4D modes. Used in clinical settings by healthcare professionals for anatomical imaging and fluid flow analysis. Includes Arterial Health Package (AHP) for Intima Media Thickness measurement to assist in cardiovascular risk communication. System performs post-processing of echoes to generate displays and specialized measurements. Benefits include non-invasive visualization of internal structures and blood flow to support clinical diagnosis.
Clinical Evidence
No clinical data submitted. Substantial equivalence is based on technological characteristics, bench testing, and compliance with recognized safety standards (electrical, thermal, electromagnetic, and acoustic output).
Technological Characteristics
Mobile ultrasound system with flat panel display. Supports B, M, PW, CW, Color, and Power Doppler modes. Features include tissue harmonic imaging, spatial compounding (SieClear), and automated measurement packages (AHP, Auto OB, Auto Left Heart). Connectivity via DICOM 3.0. Complies with IEC 60601-1, IEC 60601-2-37, and AIUM/NEMA UD-2/UD-3 standards.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in cardiac, fetal, abdominal, pediatric, small organ, adult cephalic, transcranial, OB/GYN, pelvic, urological, vascular, and musculoskeletal applications. Used as an imaging aid; specific restrictions apply to IVF, CVS, and PUBS procedures.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- ACUSON NX2 (K172374)
- ACUSON NX2 Elite (K172374)
Related Devices
- K172374 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Aug 15, 2017
- K232617 — ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Sep 26, 2023
- K173957 — ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Feb 1, 2018
- K123001 — ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Oct 26, 2012
- K221190 — ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Aug 16, 2022
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
February 2, 2018
## Re: K173981
Trade/Device Name: ACUSON NX2 Diagnostic Ultrasound System ACUSON NX2 Elite 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: January 26, 2018 Received: January 29, 2018
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 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);
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# Page 2 - Mark Job
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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
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DEPARTMENTO FHEACTH AND HUMANISERVICES Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
#### 510(k) Number (if known)
K173981
Device Name
ACUSON NX2 Diagnostic Ultrasound System ACUSON NX2 Elite Diagnostic Ultrasound System
#### Indications for Use (Describe)
The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications Cardiac. Fetal. Abdominal (including liver), Pediatric, Small Organ), Adult Cephalic, Transcranial, OBA 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), choronic 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 Ident to Subclinical Vascular Disease and Evaluate Cardiovasular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vasoular Medicine
| 100<br>as applicable)<br>Select<br>one<br>poin<br>use | | |
|-------------------------------------------------------|--|--|
| Inne | | |
| | | |
| | | |
> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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510(k) Number (if known):
Device Name: Intended Use: K173981
QUICK-HYVE™ D: 6-Hy -Isoflavone
ACUSON NX2™ Diagnostic Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | |
| | Trans-rectal | P | P | P | | P | P | P | |
| | Trans-vaginal | P | P | P | | P | P | P | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | P | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | P | |
| | Intra -vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared (K172374)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(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)
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510(k) Number (if known):
Device Name:
Intended Use:
K173981
ACUSON NX2 Elite Diagnostic Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------|------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | P | P | P | P | |
| | Trans-rectal | P | P | P | | P | P | P | |
| | Trans-vaginal | P | P | P | | P | P | P | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | P | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | P | |
| | Intra -vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | |
| Vessel | Other (Specify) | | | | | | | | |
| | N = new indication; P = previously cleared (K172374) | | | | | | | | |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(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)
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| 510(k) Number (if known): | | K173981 | | | | | | | | |
|-----------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---|---|-----|-----|------------------|------------------|----------------------|
| Device Name: | | CH5-2 Convex Array Transducer for use with:<br>ACUSON NX2 TM Diagnostic Ultrasound System /<br>ACUSON NX2 Elite Diagnostic Ultrasound System | | | | | | | | |
| Intended Use: | | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| | | Other<br>(Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | P | |
| | Abdominal | | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | P | |
| | SmallOrgan<br>(Note 1) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | |
| | Intra-vascular | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | P | |
| | Other (Specify) | | | | | | | | | |
N = new indication; P = previously cleared (K172374)
For example: breast, testes, thyroid, penis, prostate, etc.
For example: abdominal, vascular Note 1
Note 2
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(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)_
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| 510(k) Number (if known): | K173981 |
|---------------------------|--------------------------------|
| Device Name: | VF10-5 Linear Array Transducer |
Intended Use:
er for use with: ACUSON NX2™ Diagnostic Ultrasound System / ACUSON NX2 Elite Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|----------------------------|-------------------------------|-------------------|---|-----|-----|------------------|------------------|----------------------|--------------------|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | P | | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | P | | |
| | Intra-vascular | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | | |
| Vessel | Other (Specify) | | | | | | | | | |
previously cleared (K172374) N = new tion: F =
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(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)_
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| 510(k) Number (if known): | K173981 |
|---------------------------|---------|
|---------------------------|---------|
C5-2v Convex Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System / ACUSON NX2 Elite 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<br>(Track 1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared (K172374)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Note 3 Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M
(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)
{8}------------------------------------------------
L10-5v Linear Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System / Device Name: ACUSON NX2 Elite Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
K173981
Intended Use:
| Clinical Application | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|---|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal | Pediatric | P | P | P | | P | P | P | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | | P | P | P | |
| | Musculo-skel.<br>(Superfic) | P | P | P | | P | P | P | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared (K172374)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(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}------------------------------------------------
EC9-4 Convex Array Transducer for use with:
ACUSON NX2™ Diagnostic Ultrasound System / Device Name: ACUSON NX2 Elite Diagnostic Ultrasound System Diagnostic imaging or fluid flow analysis of the human body as follows:
K173981
Intended Use:
| Clinical Application | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|---|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| Fetal<br>Imaging<br>& Other | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P | |
| | Trans-vaginal | P | P | P | | P | P | P | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared (K172374)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(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)
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
K173981
| Intended Use: | | ACUSON NX2™ Diagnostic Ultrasound System /<br>ACUSON NX2 Elite Diagnostic Ultrasound System<br>Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
|-----------------------------|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----|-----|------------------|------------------|----------------------|--------------------|--|--|--|
| | Clinical Application | | Mode of Operation | | | | | | | | | |
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | | | | |
| | Abdominal | P | P | P | | P | P | P | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| Fetal | Laparoscopic | | | | | | | | | | | |
| | Pediatric | | | | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | P | P | P | | P | P | P | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph. | | | | | | | | | | | |
| | (non-Card.)<br>Musculo-skel. | | | | | | | | | | | |
| | (Convent.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | | | | |
#### Diagnostic Ultrasound Indications for Use Form
P4-2 Phased Sector Array Transducer for use with:
N = new indication; P = previously cleared (K172374)
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
-
Note 2
For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(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)_
Indications for Use Forms
{11}------------------------------------------------
| 510(k) Number (if known): | K173981 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | C8F3 Transducer for use with:<br>ACUSON NX2™ Diagnostic Ultrasound System /<br>ACUSON NX2 Elite Diagnostic Ultrasound System |
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | Mode of Operation | | | | | | | | |
|-----------------------------|-------------------------------|---|---|-----|-----|------------------|------------------|----------------------|--------------------|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) |
| | Ophthalmic | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | |
| | Abdominal | P | P | P | | P | P | P | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | |
| | Intra-vascular | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
Other (Specify) N = new indication; P = previously cleared (K172374)
Peripheral vessel
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 For example: abdominal, vascular
Combined modes are B/M, B/C, B/PWD, B/Power, B/C/PWD or CWD, B/C/M Note 3
(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)_
Peripheral
Vessel
{12}------------------------------------------------
| 510(k) Number (if known): | | K173981 | | | | | | | | | | |
|-----------------------------|-------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----|-----|------------------|------------------|----------------------|--------------------|--|--|--|
| Device Name: | | CW2 Transducer for use with:<br>ACUSON NX2 Elite Diagnostic Ultrasound System | | | | | | | | | | |
| Intended Use: | | | Diagnostic imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | | | | |
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks11& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) | | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | | | | | | | | | | |
| | Abdominal | | | | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal | Pediatric | | | | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | | |
| | Adult Cephalic | | | | P | | | | | | | |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| | Cardiac Adult | | | | P | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | | | | |
| | Intra-vascular<br>(Ca…
