ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
Device Facts
| Record ID | K162243 |
|---|---|
| Device Name | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System |
| Applicant | Siemens Medi Cal Solutions, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Sep 6, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician 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 in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Device Story
Multi-purpose mobile diagnostic ultrasound system; acquires harmonic ultrasound echo data; displays in B-Mode, PW/CW Doppler, Color Doppler, Amplitude Doppler, combined modes, or 3D/4D imaging on flat panel display. Used in clinical settings by physicians/technicians. Provides anatomical measurements and calculation packages (e.g., Arterial Health Package for Intima Media Thickness) to assist clinical diagnosis. Output viewed on-screen; aids physician in assessing cardiovascular state and communicating with patients. Includes specialized catheters (AcuNav) for intra-cardiac/intraluminal visualization.
Clinical Evidence
No clinical data; bench testing only. Device evaluated for acoustic output, biocompatibility, cleaning/disinfection, and thermal/electrical/electromagnetic/mechanical safety per applicable standards.
Technological Characteristics
Mobile ultrasound system; flat panel display; supports multiple center frequencies (2.0-10.0 MHz). Patient contact materials tested to ISO 10993-1. Connectivity includes wireless. Software-controlled; supports various imaging modes (B, M, PW/CW Doppler, Color/Amplitude Doppler, 3D/4D).
Indications for Use
Indicated for fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications in adult and pediatric patients.
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 S1000 (K152369)
- Acuson S2000 (K152369)
- Acuson S3000 (K152369)
Related Devices
- K172162 — ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems · Siemens Healthcare · Aug 16, 2017
- K152369 — ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System · Siemens Medical Solutions USA, Inc. Ultrasound Group · Oct 6, 2015
- K121699 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Jun 22, 2012
- K130619 — ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Mar 21, 2013
- K141846 — ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Aug 7, 2014
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
SIEMENS MEDICAL SOLUTIONS, INC. % Mr. MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL 1394 25TH STREET, NW BUFFALO MN 55313
Re: K162243
Trade/Device Name: ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: August 4, 2016 Received: August 10, 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oolo
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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# Indications for Use
510(k) Number (if known)
K162243
#### Device Name
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound System
#### Indications for Use (Describe)
The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician 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 in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Transducer Indications for Use are on the attached pages.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span style="font-weight: bold;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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510 (k) Number (if known): Device Name: Intended Use:
ACUSON S1000, S2000, S3000 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|----------------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | P | P | P | P | P | P | P | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13, 16, 18 |
| Intraoperative<br>(Note 9) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Intraoperative<br>Neurological | P | P | P | P | P | P | P | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Small Organ<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 16, 18 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,15 |
| Trans-esophageal | P | P | P | P | P | P | P | | BMDC | Note 4 |
| Transrectal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Transvaginal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Transurethral | P | P | P | P | P | P | P | | | |
| Intravascular | P | P | P | P | P | P | P | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,10,<br>11,14,15 |
| Laparoscopic | P | P | P | P | P | P | P | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 18 |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 18 |
| Other (specify)<br>Neonatal Cardiac | P | P | P | P | P | P | P | | BMDC | Note 3,4,6, 10 |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 1 i.e. breast, testes, thyroid, penis, prostate, etc. Note 3 SieClear multi-view spatial compounding Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 9 For example: vascular, abdominal Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging Note 18 VTI
- Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 13 STIC Note 15 AHP Note 17 eSie Fusion
Note 2 Ensemble tissue harmonic imaging
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| 510 (k) Number (if known): | |
|----------------------------|----------------------------------------------------------------|
| Device Name: | 12L4 Transducer for use with ACUSON S1000, S2000 and S3000 |
| Intended Use: | Ultrasound imaging or fluid flow analysis of the human body as |
follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16 |
| Small Organ<br>(Note 1) | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5, 7,8,10,<br>11, 14 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc.
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Note 7
Note 10 Clarify VE vascular enhancement technology
compoundina/DTCE
Note 14 eSie™ Touch elasticity imaging
- Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
- Note 8 Power SieScape panoramic imaging
- Note 11 Advanced Sieclear spatial
Note 16 Custom Tissue Imaging /FTI
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
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| 510 (k) Number (if known): |
|----------------------------|
| Device Name: |
#### CW2 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative<br>(Note 9) | | | | | P | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | |
| Musculo-skeletal<br>Superficial | | | | | P | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 9 For example: vascular, abdominal
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510 (k) Number (if known): Device Name:
#### CW5 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | P | | | | | |
| Abdominal | | | | | P | | | | | |
| Intraoperative<br>(Note 9) | | | | | P | | | | | |
| Intraoperative<br>Neurological | | | | | P | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | |
| Neonatal Cephalic | | | | | P | | | | | |
| Adult Cephalic | | | | | P | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | |
| Musculo-skeletal<br>Superficial | | | | | P | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 9 For example: vascular, abdominal
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Intended Use:
### Diagnostic Ultrasound Indications for Use Form
| 510 (k) Number (if known): | |
|----------------------------|-------------------------------------------------------------------------------------|
| Device Name: | 6-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound System |
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|----------------------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,<br>11, | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,<br>11,14 | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 1 i.e .: breast, testes, thyroid, penis, prostate, etc.
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
| Note 2 | Ensemble tissue harmonic imaging |
|--------|----------------------------------|
|--------|----------------------------------|
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
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510 (k) Number (if known): Device Name:
### MC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,,7,8,10,<br>11, |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, 6, 7,8,10,<br>11,14 |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 1 i.e.; breast, testes, thyroid, penis, prostate, etc Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
- Note 5 3-Scape real-time 3D imaging
technology
Note 7 B&W SieScape panoramic imaging Note 9 Abdomen and Vascular
- Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement
Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
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510 (k) Number (if known): Device Name:
9L4 Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative<br>Note 9 | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | |
| Small Organ<br>(Note 1) | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,<br>11,14, 16, 18 | |
| Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | |
| Adult Cephalic | P | P | P | P | | P | P | | | | |
| Cardiac | P | P | P | P | | P | P | | BMDC | Note 15 | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,<br>7,8,10, 11, 14,15 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10, 11,<br>14 | |
| Musculo-skeletal<br>Superficial | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10, 11,<br>14 | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
- Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- Note 5 3-Scape real-time 3D imaqing
- Note 7 B&W SieScape panoramic imaging
- Note 9 Abdomen and Vascular
- Note 11 Advanced Sieclear spatial compounding
- Note 15 AHP
- Note 18 VTI (Virtual Touch Imaging)
-
- Note 4 Tissue Equalization Technology
- Note 6 Cadence contrast agent imaging
- Note 8 Power SieScape panoramic imaging
- Note 10Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
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| 510 (k) Number (if known): |
|----------------------------|
| Device Name: |
### 14L5 Multi-D Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,<br>7,8,10, 11, 14 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
7. Additional Comments:
Note 1. i.e. breast, testes, thyroid, penis, prostate, etc. Note
- Note 3 SieClear multi-view spatial compounding
- Note 5 3-Scape real-time 3D imaging
- Note 7 B&W SieScape panoramic imaging
- Note 9 Abdomen and Vascular
technology
Note 11 Advanced Sieclear spatial compounding Note 16 Custom Tissue Imaging
- Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4
Note 6 Cadence contrast agent imaging
- Power SieScape panoramic imaging Note 8
Clarify VE vascular enhancement Note 10
-
Note 14 eSie™ Touch elasticity imaging / FTI Note 18 Virtual Touch Imaging
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{11}------------------------------------------------
510 (k) Number (if known): Device Name:
### 4P1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 10 Clarify VE vascular enhancement technology
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{12}------------------------------------------------
| 510 (k) Number (if known): |
|----------------------------|
| Device Name: |
### 6C2 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|----------------------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Abdominal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16, 17 |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
- Note 4 Tissue Equalization Technology
Note 7 B&W SieScape panoramic imaging
Note 5 3-Scape real-time 3D imaging
Note 9 Abdomen and Vascular
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology Note 14 eSie™ Touch elasticity imaging / FTI
SieClear multi-view spatial compounding
Note 11 Advanced Sieclear spatial compounding Note 16 Custom Tissue Imaging
- Note 17 eSie Fusion
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
Note 3
{13}------------------------------------------------
| 510 (k) Number (if known): |
|----------------------------|
| Device Name: |
### 4C1 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-------------------------------------------|
| | | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8, 10, 11, 14, 16, 17, 18 |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | P | P | P | P | P | | BMDC | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
- Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 17 eSie Fusion
- Note 3 SieClear multi-view spatial compounding
- Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial
Note 16 Custom Tissue Imaging Note 18 VTI
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{14}------------------------------------------------
| 510 (k) Number (if known): |
|----------------------------|
| Device Name: |
### 6C1HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-------------------------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,<br>10, 11, 14, 16, 17,<br>18 |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | P | P | P | P | P | | BMDC | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K152369 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology compoundinq
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial
Note 16 Custom Tissue Imaging Note 18 VTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
{15}------------------------------------------------
| 510 (k) Number (if known): |
|----------------------------|
| Device Name: |
### 8C3HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14, 16 |
| Intraoperative<br>Note 9 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Small Organ | | P | P | P | | P | P | | BMDC | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |…
