ACUSON S3000, S2000 Diagnostic Ultrasound System
Device Facts
| Record ID | K183575 |
|---|---|
| Device Name | ACUSON S3000, S2000 Diagnostic Ultrasound System |
| Applicant | Siemens Healthineers |
| Product Code | IYN · Radiology |
| Decision Date | Mar 20, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | AI/ML, Pediatric |
Intended Use
The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), 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, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} 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 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. 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 AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.
Device Story
ACUSON S3000/S2000 are mobile, software-controlled diagnostic ultrasound systems; transmit/receive ultrasound echo data; display in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Color M-Mode, Doppler Tissue, Amplitude Doppler, and Harmonic Imaging. Used in clinics/hospitals by physicians/technicians. New Quantitative Ultrasound (QUS) feature measures liver attenuation coefficient (AC) and backscatter coefficient (BSC) at 3 MHz; calculates Ultrasonically-Derived Fat Fraction (UDFF) index to aid management of hepatic steatosis. Arterial Health Package (AHP) measures Intima Media Thickness. AcuNav catheter provides intraluminal/intra-cardiac visualization. Output displayed on monitor; aids clinicians in diagnosis and patient communication. Benefits include non-invasive assessment of vascular health and hepatic steatosis.
Clinical Evidence
Clinical study of 101 participants evaluated QUS performance (AC and BSC) in the liver. UDFF index validated against MRI-PDFF (mean 13.8% ± 8.9%). Results showed BMI did not significantly affect AC/BSC measurements. Trends correlated with steatosis grades (S0-S3). No adverse effects reported. Phantom studies confirmed accuracy/precision within ±20% of nominal values.
Technological Characteristics
Mobile ultrasound system; B-mode, M-mode, Doppler (PW/CW/Color/Amplitude), Harmonic Imaging. Patient contact materials tested to ISO 10993-1. Connectivity: Networked/standalone. Software version VE11A. QUS algorithm: acoustic physical tissue properties. Safety standards: IEC 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3.
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 imaging in adult and pediatric patients. AcuNav catheter indicated for intra-cardiac and intraluminal visualization of anatomy, physiology, and devices during percutaneous 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
Reference Devices
Related Devices
- K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Nov 13, 2025
- K243299 — ACUSON Redwood Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Nov 15, 2024
- K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Nov 17, 2025
- K240704 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jul 22, 2024
- K211859 — ACUSON Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Jul 20, 2021
Submission Summary (Full Text)
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March 20, 2019
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Siemens Healthineers % Ms. Christine Dunbar Sr. Regulatory Affairs Specialist 22010 SE 51 Street ISSAQUAH WA 98029
## Re: K183575
Trade/Device Name: ACUSON S3000, S2000 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, OBJ Dated: February 17, 2019 Received: February 19, 2019
Dear Ms. Dunbar:
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 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
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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).
Sincerelv.
Michael D'Hara For
Thalia Mills, 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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known) K183575
Device Name
ACUSON S3000, S2000 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 (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), 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, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} 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 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. 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 AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.
The Transducer Indications for Use on the attached pages.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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## Page 31 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
ACUSON S3000, S2000 Diagnostic Ultrasound Systems 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 2,3,4,5,7,8,10,11,13 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,11,<br>13,16,17,18,20,21 | |
| Intraoperative<br>(Note 9) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14 | |
| Intraoperative<br>Neurological | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14 | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10,11 | |
| Small Organ<br>(Note 1) | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,<br>11,14,16,18,19,20 | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| 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 2,3,4,5,7,8,10,15 | |
| Trans-esophageal | | P | P | P | P | P | P | | BMDC | Note 4 | |
| Transrectal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,<br>11,14 | |
| Transvaginal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,11,14,15 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Other (specify)<br>Neonatal cardiac | | P | P | P | P | P | P | | BMDC | Note 3,4,10,17 | |
N = new indication; P = previously cleared by K172162; K130739 (VTI); K131164(VTQ); K130881 (VTIQ)
Note 1 For example: 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
- For example: vascular, abdominal Note 9 Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
- Note 18 VTI
- Note 20 VTQ
- Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE technology Note 13 STIC Note 15 AHP Note 17 eSie Fusion
Ensemble tissue harmonic imaging Tissue Equalization Technology
- Note 19 VTIQ
Note 2
Note 4
- Note 21 QUS (Quantitative Ultrasound)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices
510(k)_
- 02.17.2019
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510 (k) Number (if known):
| Device Name: | CW2 Probe | | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| 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 K172162
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
For example: vascular, abdominal Note 9
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Division Sign-Off - Office of In Vitro Diagnostic Devices |
|-----------------------------------------------------------|
|-----------------------------------------------------------|
| 510(k) | |
|--------|--|
|--------|--|
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510 (k) Number (if known):
| Device Name: | CW5 Probe | | | | | | | | | |
|----------------------------------|-------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| 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 K172162
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 9 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)
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## Page 34 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS
### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name: | | EC9-4 Curved Array Transducer | | | | | | | | | | |
|----------------------------------|---|-------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------------|--|--|
| 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<br>2,3,4,5,6,7,8,10,11,17 | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14 | | |
| 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<br>2,3,4,5,6,7,8,10,11,14 | | |
| 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 K172162
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie™ Fusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)
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## Page 35 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS
### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name:<br>Intended Use: | 9L4 Linear Array Transducer<br>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 2,3,4,5,7,8,10,11 | |
| Abdominal | P | P | P | P | | P | P | | BMDC | Note 6,18,20 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10,11 | |
| Small Organ<br>(Note 1) | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,11,14,16,18,<br>19,20 | |
| Neonatal Cephalic | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11 | |
| 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 2,3,4,5,7,8,10,11,14,15 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14 | |
| Musculo-skeletal<br>Superficial | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,11,14 | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K172162
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- SieClear multi-view spatial compounding Note 3
- 3-Scape real-time 3D imaging Note 5
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
Note 19 VTIQ
Note 2 Ensemble tissue harmonic imaging
Note 4
te 6 Cadence contrast agent imaging
te 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear
Note 15 AHP
-
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510(k)
- Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 18 VTI Note 20 VTQ
{9}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
#### 14L5BV Multi-D Array Transducer for use on S2000
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 | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,11,14,<br>16 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| 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 K081148
Additional Comments:
- Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Ensemble tissue harmonic imaging Note 2
- Note 3 SieClear multi-view spatial compounding
- Tissue Equalization Technology Note 4
- 3-Scape real-time 3D imaging Note 5
- Note 6 Cadence contrast agent imaging
- B&W SieScape panoramic imaqinq Note 7
- Note 8 Power SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
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{10}------------------------------------------------
510 (k) Number (if known):
| Device Name:<br>Intended Use: | | 4P1 Phased Array Transducer<br>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 | | | | | | | | | | | |
| 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 2,3,4,5,7,8,10 | |
| 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 K172162
Additional Comments:
Note 2 Ensemble tissue harmonic imaqinq
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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{11}------------------------------------------------
## Page 38 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS
#### Diagnostic Ultrasound Indications for Use Form
#### 510 (k) Number (if known):
Device Name: Intended Use:
#### 6C2 Curved Array Transducer
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<br>2,3,4,5,7,8,10,11 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,11,14,<br>16,17 |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,11 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,10,11 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K172162
#### Additional Comments:
- Note 2 Ensemble tissue harmonic imaqinq
Tissue Equalization Technology Note 4
B&W SieScape panoramic imaqinq Note 7
Note 10 Clarify VE vascular enhancement technology
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
Power SieScape panoramic imaqinq Note 8
Note 11 Advanced Sieclear spatial compounding
Note 16 Custom Tissue Imaging
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{12}------------------------------------------------
510 (k) Number (if known):
| Device Name: | 4C1 Curved Array Transducer<br>Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------------------------|
| Intended Use: | | | | | | | | | | |
| | 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<br>2,3,4,5,7,8,10,11,18,<br>19,20 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,11,1<br>4,16,17 |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | | Note 6 |
| 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 K172162
Additional Comments:
- Note 2 Ensemble tissue harmonic imaqinq
- Note 4 Tissue Equalization Technology
- Note 6 Cadence contrast agent imaging
- Note 8 Power SieScape panoramic imaging
- Note 11 Advanced Sieclear spatial compounding
- Note 16 Custom Tissue Imaging
- Note 18 VTI
- Note 20 VTQ
- SieClear multi-view spatial compounding Note 3
Note 5 3-Scape real-time 3D imaginq
- B&W SieScape panoramic imaging Note 7
- Note 10 Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 17 eSie Fusion
- Note 19 VTIQ
#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)
{13}------------------------------------------------
## Page 40 of 1339 ACUSON S3000™, S2000™ Diagnostic Ultrasound System 510(k)-QUS
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
| Device Name:<br>Intended Use: | 6C1HD Curved Array Transducer HD<br>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 | P | | BMDC | Note<br>2,3,4,5,7,8,10,11 | |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,11,1<br>4,16,17,18,19,20,21 | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 6 | |
| Small Organ | P | P | P | P | P | P | P | | BMDC | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | BMDC | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | |…
