ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K121138 |
|---|---|
| Device Name | ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solution |
| Product Code | IYN · Radiology |
| Decision Date | May 17, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The S3000™ 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Acuson Acunav Ultrsound Catheter is intended for 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
S3000 is a mobile, software-controlled diagnostic ultrasound system; acquires harmonic ultrasound echo data; displays in B-Mode, M-Mode, PW/CW Doppler, Color Doppler, Amplitude Doppler, and 3D/4D imaging. Used in clinical settings by physicians/technicians for anatomical visualization and measurement. Includes Arterial Health Package (AHP) for Intima Media Thickness measurement; supports specialized transducers including AcuNav catheters for intra-cardiac/intra-luminal visualization. Output displayed on 19" flat panel; provides thermal/mechanical indices for bio-effect monitoring. Assists clinicians in diagnosis and patient communication regarding cardiovascular health.
Clinical Evidence
Bench testing only. Device evaluated for acoustic output, biocompatibility (ISO 10993-1), cleaning/disinfection, and thermal/electrical/electromagnetic/mechanical safety per UL 60601-1, IEC 60601-2-37, and AIUM/NEMA standards.
Technological Characteristics
Mobile ultrasound system; 19" FPD; supports multiple transducers (curved, linear, phased array, TEE, catheter). Connectivity: networked. Software-controlled. Patient contact materials tested to ISO 10993-1. Safety standards: UL 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 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 Antares
- Acuson S2000 (K111674, K093812, K090334, K072786, K081148)
Reference Devices
- Siemens V7M (K063085)
- AcuNav 8F (K071234)
- AcuNav 10F (K071234)
Related Devices
- K111674 — ACUSON · Siemens Medical Solutions USA, Inc. · Jun 30, 2011
- K163635 — ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems · Siemens Medical Solutions USA, Inc. Ultrasound Group · Jan 12, 2017
- K172162 — ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems · Siemens Healthcare · Aug 16, 2017
- K192835 — ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · Oct 22, 2019
- K162243 — ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System · Siemens Medi Cal Solutions, Inc. · Sep 6, 2016
Submission Summary (Full Text)
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K121138
MAY 1 7 2012
# 7 of 3658
#### Siemens Medical Solutions, Inc. Ultrasound Division
S3000 Ultrasound System 510(k) Submission
#### 510(k) Summarv Prepared March 19, 2012
1. Sponsor:
Siemens Medical Solutions, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043
Contact Person:
Shelly Pearce Telephone: (650) 694-5988 Fax: (650) 694-5580
2. Device Name: Acuson S3000™ Diagnostic Ultrasound System
Diagnostic Ultrasound System Common Name:
Classification:
Regulatory Class: = Review Category: Tier II Classification Panel: Radiology
Ultrasonic Pulsed Doppler Imaging System FR # 892.1550 Product Code 90-IYN Ultrasonic Pulsed Echo Imaging System FR # 892.1560 Product Code 90-IYO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX Diagnostic Ultrasound Catheter FR # 870.1200 Product Code OBJ
## 3. Legally Marketed Predicate Devices
The Acuson S3000™Ultrasound System is substantially equivalent to the company's own Acuson Antares and S2000 Ultrasound Systems.
## 4. Device Description:
The S3000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to our current S2000 product (K111674, K093812, K090334, K072786, K081148), and Siemens V7M (K063085), AcuNav 8F and AcuNav 10F (K071234) transducers. These predicates are legally marketed devices.
## 5. Intended Use
The S3000™ 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.
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The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Acuson Acunav Ultrsound Catheter is intended for 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.
| Feature / Characteristic | Acuson S3000 | Acuson S2000 K072786 | Acuson S2000 K093812 | Acuson S2000 K090334 | Acuson S2000 K111674 |
|-----------------------------------------------|--------------------------|----------------------------|----------------------------|----------------------------|----------------------------|
| Indications for Use: | | | | | |
| ■ Fetal | √ | √ | √ | √ | √ |
| ■ Abdominal | √ | √ | √ | √ | √ |
| ■ Intraoperative abdominal and vascular | √ | √ | √ | √ | √ |
| ■ Intraoperative neurological | - | - | - | - | - |
| ■ Pediatric | √ | √ | √ | √ | √ |
| ■ Small Organ | √ | √ | √ | √ | √ |
| ■ Neonatal cephalic | √ | √ | √ | √ | √ |
| ■ Adult Cephalic | √ | √ | √ | √ | √ |
| ■ Cardiac | √ | √ | √ | √ | √ |
| ■ Trans-esophageal | √ | √ | √ | √ | √ |
| ■ Transrectal | √ | √ | √ | √ | √ |
| ■ Transvaginal | √ | √ | √ | √ | √ |
| ■ Peripheral vessel | √ | √ | √ | √ | √ |
| ■ Laparoscopic | - | - | - | - | - |
| ■ Musculo-skeletal (conventional) | √ | √ | √ | √ | √ |
| ■ Musculo-skeletal (superficial) | √ | √ | √ | √ | √ |
| Center Frequencies Supported: | | | | | |
| ■ 2.0 MHz | √ | √ | √ | √ | √ |
| ■ 3.0 MHz | √ | √ | √ | √ | √ |
| ■ 3.2 MHz | √ | √ | √ | √ | √ |
| ■ 3.3 MHz | √ | √ | √ | √ | √ |
| ■ 4.2 MHz | √ | √ | √ | √ | √ |
| Feature / Characteristic | Acuson S3000 | Acuson S2000 K072786 | Acuson S2000 K093812 | Acuson S2000 K090334 | Acuson S2000 K111674 |
| 4.4 MHz | √ | √ | √ | √ | √ |
| 4.8 MHz | √ | √ | √ | √ | √ |
| 5.0 MHz | √ | √ | √ | √ | √ |
| 5.2 MHz | √ | √ | √ | √ | √ |
| 6.0 MHz | √ | √ | √ | √ | √ |
| 6.5 MHz | √ | √ | √ | √ | √ |
| 6.9 MHz | √ | √ | √ | √ | √ |
| 9.5 MHz | √ | √ | √ | √ | √ |
| 10.0 MHz | √ | √ | √ | √ | √ |
| Modes: | | | | | |
| B | √ | √ | √ | √ | √ |
| Parallel processing in B mode | √ | √ | √ | √ | √ |
| M | √ | √ | √ | √ | √ |
| PWD (Pulsed Wave Doppler) | √ | √ | √ | √ | √ |
| CWD (Continuous Wave Doppler) | √ | √ | √ | √ | √ |
| D (Color Doppler) | √ | √ | √ | √ | √ |
| Amplitude Doppler | √ | √ | √ | √ | √ |
| Combined (BMDC) | √ | √ | √ | √ | √ |
| Features: | | | | | |
| Quad processing in color | √ | | | | √ |
| Native TM tissue harmonic imaging | √ | | | | √ |
| SieScape TM panoramic imaging | √ | | | | √ |
| Color SieScape TM panoramic imaging | √ | | | | √ |
| 3-Scape TM real-time 3D imaging | √ | | | | √ |
| fourSight TM 4D transducer technology | √ | | | | √ |
| TEQ TM ultrasound technology | √ | | | | √ |
| Cardiac Imaging physiological signal display | √ | | | | √ |
| syngo ® Auto OB measurements | √ | | | | √ |
| Advanced SieClear TM spatial compounding | √ | | | | √ |
| STIC | √ | | | | √ |
| Amnioscopic rendering | √ | | | | √ |
| Cadence contrast agent imaging | √ | | | | √ |
| Clarify TM vascular enhancement technology | √ | | | | √ |
| eSie TM Touch elasticity imaging | √ | | | | √ |
| syngo® Auto Left heart | √ | | | | √ |
| syngo ® Velocity Vector Imaging | √ | | | | √ |
| Semi Auto-segmentation | √ | | | | √ |
| Custom Tissue Imaging / Speed of Sound | √ | | | | √ |
| AHP | √ | | | | √ |
| Monitor: 19" FPD | √ | | | | √ |
| Feature / Characteristic | Acuson<br>S3000 | Acuson<br>S2000<br>K072786 | Acuson<br>S2000<br>K093812 | Acuson<br>S2000<br>K090334 | Acuson<br>S2000<br>K111674 |
| Patient Contact Materials . | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 | Tested to ISO<br>10993-1 |
| UL 60601-1 Certified | √ | √ | √ | √ | √ |
#### 6. Summary of Technological Characteristics - New Device Compared to Predicate
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## Siemens Medical Solutions, Inc. Ultrasound Division
## S3000 Ultrasound System 510(k) Submission
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## Siemens Medical Solutions, Inc. Ultrasound Division
## 7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
The device has been evaluated for acqustic output, biocompatibility, cleaning and disinfection, effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- UL 60601-1, Safety Requirements for Medical Equipment .
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards "
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical 트 Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive ■
- Safety and EMC Requirements for Medical Equipment 체
- . EN/IEC 60601-1
- . EN/IEC 60601-1-1
- EN/IEC 60601-1-2 I
- IEC 1157 Declaration of Acoustic Power ■
- ISO 10993-1 Biocompatibility I
Cleared patient contact materials, electrical and mechanical safety are unchanged.
## 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the S3000 uses the same technology and principles as existing devices, clinical data is not required.
#### 9. Summary
Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the S3000 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The overall design is simple and conveys a sense of official government branding.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Third Party Consultant Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
MAY 1 7 2012
Re: K121138
Trade/Device Name: S3000TM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 10, 2012 Received: May 14, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the S3000™ Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
CW2 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array 4P1 Phased Array 6C2 Curved Array
4C1 Curved Array 6C1HD Curved Array 8C3HD Curved Array 4V1 Phased Array 10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved array mechanical 3D
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9EVF4 Curved Array V5Ms Multiplane TEE 18L6 HD Linear Array 8V3 Phased Array 4V1c Phased Array
રા રે -EV8C4 V7M TEE AcuNav 8F Ultrasound Catheter AcuNay 10F Ultrasound Catheter
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Jeffrey J. Ballyns at (301) 796-6105.
Sincerely Yours.
Andres D'Okon for
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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## S3000 Ultrasound System 510(k) Submission
#### 1.3 Indications for Use
A. 510(k) Number (if known):
Device Name: S3000™Diagnostic Ultrasound System
#### Indications for Use: ·
The S3000™ 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Acuson Acunav Ultrsound Catheter is intended for 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.
Prescription Use × (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arunl Doth
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 6121138
Page 1 of
S3000 510(k) Submission
Page 14 of 59
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## 1.3 Indications for Use Forms
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
#### ACUSON 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 | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Abdominal | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13, 16 |
| Intraoperative<br>(Note 9) | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Intraoperative<br>Neurological | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Pediatric | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Small Organ<br>(Note 1) | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14, 16 |
| Neonatal Cephalic | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | | N | N | N | N | N | N | | BMDC | Note<br>2,3,4,5,6,7,8,10,15 |
| Trans-esophageal | | N | N | N | N | N | N | | BMDC | Note 4 |
| Transrectal | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Transvaginal | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,6,7,8,10,<br>11,14,15 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Musculo-skeletal<br>Superficial | | N | N | N | N | N | N | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Other (specify)<br>Neonatal Cardiac | | N | N | N | N | N | N | | BMDC | Note 3,4,6, 10 |
N = new indication; P = previously cleared by FDA K063085, K072786, K081148, K092142, K090334, K111674
For example: breast; testes, thyroid, penis, prostate, etc. Note 1
Note 3 SieClear multi-view spatial compounding
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Note 9 For example: vascular, abdominal
Note 11 Advanced Sieclear spatial compounding
eSie™ Touch elasticity imaging / FTI Note 14
Custom Tissue Imaging Note 16
| 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 2 Ensemble tissue harmonic imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRA, Office of In Vite Diagnostic Devices (OIVD) Prescription Use. Bart 1 OER 801 Submart D)
> (Division Sign-Off) Bivision of Radiological Devices Offise of In Vitro Diagnostic Device Evaluation and Safety
| | S3000 510(k) Submission |
|--|-------------------------|
|--|-------------------------|
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#### S3000 Ultrasound System 510(k) Submission
# Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
CW2 Probe for use with ACUSON S3000
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 K# 063803; K072786, K081148, K082142, K111674
Additional Comments:
RIOK
For example: breast, testes, thyroid, penis, prostate, etc. Note 1 · Note 9 For example: vascular, abdominal
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Bign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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## S3000 Ultrasound System 510(k) Submission
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: CW5 Probe for use with ACUSON S3000
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 | | | | | | | | | i . | |
| 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 K# 063803, K072786, K081148, K082142, K111674
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note a 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) Prescription Use (Part 21CFR 801 Subpart D)
(Division Sign-Off)
Division of Radiological Device: Evaluation and Sefat
Office of In Vitro Diagnostic Device Evaluation and Safety
510K: K121138
{10}------------------------------------------------
## S3000 Ultrasound System 510(k) Submission
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
EC9-4 Curved Array Transducer for use with ACUSON S3000 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, 11, |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| 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 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 K# 063803, K072786, K081148, K082142, K111674
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
3-Scape real-time 3D imaging Note 5
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 / FT1
(PLEASE DO NOT W
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of RadiologicalDomagarrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vito Diagnosic Device Evauation and Safescription Use (Part 21CFR 801 Subpart D)
510K. Klaii38
S3000 510{k) Submission
{11}------------------------------------------------
#### S3000 Ultrasound System 510(k) Submission
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
9L4 Linear Array Transducer for use with ACUSON S3000 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 | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11,14,<br>16 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Adult Cephalic | | P | P | P | | P | P | | | |
| Cardiac | | P | P | P | | P | P | | BMDC | Note 15 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11,<br>14,15 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- 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 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 15 AHP
Note 16 Custom Tissue Imaging
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121138
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
14L5 Multi-D Array Transducer for use with ACUSON S3000 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 | | | | | | | | | | | |
| 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 K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Ensemble tissue harmonic imaging Note 2
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- Note 5 3-Scape real-time 3D imaging
- Cadence contrast agent imaging Note 6
- Note 7 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note 8 Note 10 Clarify VE vascular enhancement technology
- Advanced Sieclear spatial compounding
- Note 11 eSie™ Touch elasticity imaging / FTI Note 14
-
- Note 16 Custom Tissue Imaging
Mum D. O'the
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety ElOK
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if.known):
Device Name: Intended Use:
4P1 Phased Array Transducer for use with ACUSON S3000 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>Abdominal | | | | | | | | | | |
| 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 K# 063803, K072786, K081148, K090334, K093812, K111674
Additional Comments:
Ensemble tissue harmonic imaging Note 2
Note 3 SieClear multi-view spatial compounding
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Cadence contrast agent imaging Note 6
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Part 21CFR 801 Subpart D)
Pre
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
K121/38
S3000 510(k) Submission
{14}------------------------------------------------
## S3000 Ultrasound System 510(k) Submission
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
6C2 Curved Array Transducer for use with ACUSON \$3000 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>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | 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 | | 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 K# 063085, K072786, K081148, K080334, K093812, K111674
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
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 16 Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Ot) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division of Radiological Devices Prescription Use (Part 21CFR 801 Subpart D)
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K12138
S3000 510(k) Submission
{15}------------------------------------------------
## S3000 Ultrasound System 510(k) Submission
#### Diagnostic Ultrasound Indications for Use Form
- 510 (k) Number (if known):
Device Name: Intended Use:
4C1 Curved Array Transducer for use with ACUSON S3000 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 | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| 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 K# 063085, K072786, K081148, K090334, K093812, K111674
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- 3-Scape real-time 3D imaging Note 5
- Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note 8
- Clarify VE vascular enhancement technology Note 10
Note 10 Clarity VE vascular enhancement technology
Note 11 Advanc…
