ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System
Device Facts
| Record ID | K192835 |
|---|---|
| Device Name | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 22, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Adult Cephalic, 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. The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), 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. 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 should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."
Device Story
Mobile, software-controlled diagnostic ultrasound system; transmits/receives ultrasound echo data; displays images in B-Mode, PW/CW Doppler, Color Doppler, Color M, Doppler Tissue, Amplitude Doppler, Harmonic, and 3D/4D imaging. Used in clinical settings by physicians/sonographers for anatomical measurement and clinical diagnosis. Includes Arterial Health Package (AHP) for Intima Media Thickness measurement. Output displayed on flat panel monitor; assists clinicians in visualizing structures and fluid flow to support diagnostic decision-making.
Clinical Evidence
No clinical data required; substantial equivalence based on identical technology and principles to previously cleared predicate devices.
Technological Characteristics
Multi-purpose diagnostic ultrasound system; 64-channel architecture; supports 2.0-13.0 MHz center frequencies. Patient contact materials tested to ISO 10993-1. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and AIUM/NEMA UD-2/UD-3 standards. Features include SieClear, eSie Touch, and DICOM integration.
Indications for Use
Indicated for fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, transcranial, OB/GYN, pelvic, neonatal, cardiac (including transesophageal), vascular (including peripheral vessel), musculoskeletal, superficial musculoskeletal, and urology diagnostic ultrasound imaging and measurement.
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 NX3 (K173957)
- ACUSON NX3 Elite (K173957)
Related Devices
- K173981 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. Ultrasound Group · Feb 2, 2018
- K172162 — ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems · Siemens Healthcare · Aug 16, 2017
- K232617 — ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Sep 26, 2023
- K121699 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jun 22, 2012
- K201130 — ACUSON Juniper Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · May 26, 2020
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions, USA, Inc. % Mr. Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k SAINT PAUL MN 55114
October 22, 2019
### Re: K192835
Trade/Device Name: ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 1, 2019 Received: October 2, 2019
### Dear Mr. Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
### 510(k) Number (if known)
# K192835
#### Device Name
ACUSON NX3 Diagnostic Ultrasound System ACUSON NX3 Elite Diagnostic Ultrasound System
### 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), Neonatal Cephalic, 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.
#### For ACUSON NX3 Elite
The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal. Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), 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.
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 should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American 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.
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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<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) | P | P | P | | P | P | P | |
| | 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 | P | P | P | | P | P | P | |
| | 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) | P | P | P | P | P | P | P | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared by (K173957)
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
For example: abdominal, vascular 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)_
Page 1 of 19
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510(k) Number (if known):
ACUSON NX3™ 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) | | | | | | | | |
| Fetal | Laparoscopic<br>Pediatric | P | P | P | | P | P | P | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | P | P | P | | P | P | P | |
| | 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 | |
| Cardiac | Cardiac Pediatric | 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 by (K173957)
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2
Note 3 For example: abdominal, vascular
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)_
Page 2 of 19
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510(k) Number (if known):
| Device Name: | CH5-2 Transducer for use with:<br>ACUSON NX3 Elite™ Diagnostic Ultrasound System / ACUSON NX3™ Diagnostic Ultrasound<br>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>(Tracks 1& 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<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 by (K173957)
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)_
Page 3 of 19
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510(k) Number (if known):
Device Name:
VF10-5 Linear Array Transducer for use with:
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<br>( Track 1<br>Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Note 3) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal<br>Abdominal | P | P | P | | P | P | P | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro)<br>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 by (K173957)
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)_
Page 4 of 19
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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<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<br>- NX3 Elite only | P | P | P | | P | P | P | |
| | 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 by (K173957) | | | | | | | | | |
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)_
Page 5 of 19
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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<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 | |
| | Abdominal | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | |
| | Neonatal Cephalic | P | P | P | | P | P | P | |
| | 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 Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-Cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral | Peripheral vessel | | | | | | | | |
| Vessel | Other (Specify) | | | | | | | | |
N = new indication; P = previously cleared by (K173957)
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)_
Page 6 of 19
{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 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>(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 | | | | | | | | | |
| | Intra-operative<br>(Note 2) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | | |
| | Neonatal Cephalic<br>- NX3 Elite Only | P | P | P | | P | P | P | | |
| | 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 Adult | | | | | | | | | |
| Cardiac | 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 by (K173957) | | | | | | | | | |
1. non-incidentally + previously cleared?) (***.***)
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)_
Page 7 of 19
{11}------------------------------------------------
510(k) Number (if known):
CW2 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 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 | | | | | | | | | | |
| | Abdominal | | | | | | | | | | |
| | 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 | Cardiac Adult | | | P | | | | | | | |
| | Cardiac Pediatric | | | P | | | | | | | |
| | 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 by (K173957) | | | | | | | | | | | |
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
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)_
Page 8 of 19
{12}------------------------------------------------
510(k) Number (if known):
CW5 Continuous Wave Doppler Transducer for use with:
ACUSON NX3 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>(Tracks1I& 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<br>Imaging<br>& Other | Pediatric | | | | | | | | |
| | 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<br>Other | | | | | | | | |
| | (Specify) | | | | | | | | |
| | Cardiac Adult | | | | P | | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| N = new indication; P = previously cleared by (K173957) | | | | | | | | | |
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
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)_
Page 9 of 19
{13}------------------------------------------------
510(k) Number (if known):
**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
Intended Use:
Device Name:
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<br>Imaging<br>& Other | Pediatric | P | P | P | | P | P | P | | |
| | SmallOrgan<br>(Note 1) | P | P | P | | P | P | P | | |
| | Neonatal Cephalic<br>- NX3 Elite Only | P | P | P | | P | P | P | | |
| | Adult Cephalic | P | P | P | | P | P | 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 | 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<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
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)_
Page 10 of 19
{14}------------------------------------------------
510(k) Number (if known):
VF16-5 Transducer for use with:
ACUSON NX3 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>(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 | |…
