ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K093812 |
|---|---|
| Device Name | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Mar 3, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric, 3rd-Party Reviewed |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K093812 · Mar 3, 2010 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | Peer-reviewed clinical literature containing normative population data | The device software references published normative tables for Intima Media Thickness to assist clinicians in communicating cardiovascular risk to patients. | Intima Media Thickness; Normative tables; Peer-reviewed literature; Cardiovascular risk |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease; Consensus statement and literature review | General population (normative data) | Not applicable for this study | Intima Media Thickness normative values |
Indications for Use
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac, Pelvic, Neonatal/Adult Cephalic, Vasculoskeletal, 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".
Device Story
Acuson S2000 is a diagnostic ultrasound system; utilizes various transducers to acquire acoustic signals from human anatomy; transforms signals into real-time 2D, 3D, Doppler, and M-mode images. Operated by clinicians in clinical settings; provides anatomical measurements and calculation packages (e.g., Arterial Health Package for Intima Media Thickness). Output displayed on system monitor; assists physicians in clinical diagnosis and patient communication regarding cardiovascular health. Benefits include non-invasive visualization and quantification of anatomical structures and blood flow.
Clinical Evidence
Bench testing only. Device complies with UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2, and AIUM/NEMA UD-3 standards. Biocompatibility testing performed per ISO 10993-1.
Technological Characteristics
Diagnostic ultrasound system; supports multiple transducer types (curved, linear, phased array, TEE, catheter). Energy source: electrical/ultrasonic. Connectivity: standard ultrasound system interfaces. Software includes measurement/calculation packages and Arterial Health Package (AHP). Biocompatibility per ISO 10993-1. Safety standards: UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2/UD-3.
Indications for Use
Indicated for ultrasound imaging or fluid flow analysis of the human body in fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, and peripheral vascular applications. Used by physicians for clinical diagnosis.
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 Ultrasound System
Submission Summary (Full Text)
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K093812
## Siemens Medical Solutions, Inc. Ultrasound Division
S2000 Ultrasound System 510(k) Submission
## 510(k) Summary Prepared December 28, 2009
| Sponsor: | Siemens Medical Solutions, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>Mountain View, California 94043 | MAR - 3 2010 | |
|------------------|------------------------------------------------------------------------------------------------------------------|--------------|--|
| Contact Person: | Shelly Pearce<br>Telephone: (650) 694-5988<br>Fax: (650) 694-5580 | | |
| Submission Date: | December 1, 2009 | | |
| Device Name: | Acuson S2000™ Diagnostic Ultrasound System | | |
| Common Name: | Diagnostic Ultrasound System | | |
## Classification:
Regulatory Class: ll 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 |
## A. Legally Marketed Predicate Devices
The Acuson S2000™ Ultrasound System is substantially equivalent to the Acuson Antares Ultrasound System.
## B. Device Description:
The Acuson S2000™ has been designed to meet the following product safety standards:
- l UL 60601-1, Safety Requirements for Medical Equipment
- l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- t CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- li AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- t 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment 트
- . EN/IEC 60601-1
- . EN/IEC 60601-1-1
- I EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power 트
- ISO 10993-1 Biocompatibility l
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## C. Intended Use
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac, Pelvic, Neonatal/Adult Cephalic, Vasculoskeletal, 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".
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 3 2010
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K093812
Trade/Device Name: ACUSON S2000™ 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: February 8, 2010 Received: February 16, 2010
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 ACUSON S2000™ Diagnostic Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
CW2 CW5 EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array 14L5BV Multi-D Array 4P1 Phased Array 6C2 Curved Array
4C1 Curved Array 4V1 Phased Array 10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array Mechanical 3D 9EVF4 Curved Array V5Ms Multiplane TEE 17L5HDS Linear Array
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| 18L6 HD Linear Array | EV8C4 |
|----------------------|--------------------------------|
| 8V3 Phased Array | V7M TEE |
| 4V1c Phased Array | AcuNav 8F Ultrasound Catheter |
| 6L3 | AcuNav 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/CDRH/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 Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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#### 1.3 Indications for Use
A. 510(k) Number (if known):
Device Name: S2000™Diagnostic Ultrasound System
Indications for Use:
The S2000™ 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 reaarding 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".
Prescription Use (Part 21 CFR 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 Device Evaluation (ODE)
signature
Olvision of Radiolor
610K Kc93812
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## 1.3 Indications for Use Forms
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
## ACUSON S2000 Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | 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, 13 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13, 16 |
| Intraoperative<br>(Note 9) | | 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 | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| 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 2,3,4,5,7,8,10,<br>11,14, 16 |
| 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<br>2,3,4,5,6,7,8,10,15 |
| Trans-esophageal | | P | P | P | P | P | P | | BMDC | |
| Transrectal | | 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 | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,10,<br>11,14,15 |
| 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 | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Other (specify)<br>Neonatal Cardiac | | P | P | P | P | P | P | | BMDC | Note 3,4,6 |
N = new indication; P = previously cleared by FDA K063085, K072786, K081148, K082142, K090334
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
- Cadence contrast agent imaging Note 6
- B&W SieScape panoramic imaging Note 7
- Power SieScape panoramic imaging Note 8
- Note 9 For example: vascular, abdominal
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- STIC Note 13
- Note 14 eSie™ Touch elasticity imaging / FTI
Note 15 AHP
Note 16 Custom Tissue Imaging
(Division Sign-Off)
(Division Aign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Sately
510K K093812
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#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.10 Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: CW2 Probe for use with ACUSON 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 | | | | | 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, K090334
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 Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
A-A
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093812
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510 (k) Number (if known):
CW5 Probe for use with ACUSON S2000
Device Name: 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 K# 063803, K072786, K081148, K080334
Additional Comments:
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) Concurrence of CDRH, Office of Bevice: Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
D. A. D
(Division Sign-Of Division of Radiological D Vitro Diagnostic Device Evaluation and Safety Office of In
510K
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510 (k) Number (if known):
Device Name: Intended Use:
EC9-4 Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (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 Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (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, 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 Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063803, K072786, K081148, K080334
#### Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Ensemble tissue harmonic imaging Note 2
- SieClear multi-view spatial compounding Note 3
- 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 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
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093812
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (ODE) / T
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510 (k) Number (if known):
#### 9L4 Linear Array Transducer for use with ACUSON S2000
Device Name: 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 | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | |
| 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 (snecify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 2 Ensemble tissue harmonic imaging
- SieClear multi-view spatial compounding Note 3
- Note 4 Tissue Equalization Technology
- 3-Scape real-time 3D imaging Note 5
- Note 6 Cadence contrast agent imaging
- B&W SieScape panoramic imaging Note 7
- 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 15 AHP
- Note 16 Custom Tissue Imaging
---
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093812
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OIL i
{10}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use: 14L5 Multi-D Array Transducer for use with ACUSON S2000 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 | | | | | | | | | | |
| 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
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
- 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
- Note 8 Power SieScape panoramic imaging
- Clarify VE vascular enhancement technology Note 10
- Advanced Sieclear spatial compounding Note 11
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Disonostic Davice Evaluation and Safety
510K K093812
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice-Evaluation (ODE) Office T
{11}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
14L5BV Multi-D Array Transducer for use with ACUSON 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<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 | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 081148
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
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
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
(Division Sign-Off Division of Radiological De Office of In Vitro Diagnostic Device Evaluation
510K. K093812
{12}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
4P1 Phased Array Transducer for use with ACUSON 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 | | 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 Additional Comments:
Ensemble tissue harmonic imaging Note 2
SieClear multi-view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093812
{13}------------------------------------------------
.. .. ......
510 (k) Number (if known):
Device Name:
Intended Use:
6C2 Curved Array Transducer for use with ACUSON 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 | 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 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| 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 | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334
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
- Note 7 B&W SieScape panoramic imaging
- Note 8 Power SieScape panoramic imaging
- Clarify VE vascular enhancement technology Note 10
- Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
JAD
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093812
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice Evaluation (ODE) OF CO
{14}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use: 4C1 Curved Array Transducer for use with ACUSON 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 | | 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, K080334
Additional Comments:
- Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- 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
- Clarify VE vascular enhancement technology Note 10
- Advanced Sieclear spatial compounding Note 11
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
HAB
(Division Sign-Off Division of Radiological Device: Office of In
510K K093812
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Bevice Evaluation (ODE) Of V /
{15}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
4V1 Phased Array Transducer for use with ACUSON 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 | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>14, 16 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| 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 K# 063085, K072786, K081148, K090334
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 7 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note 8
- Clarify VE vascular enhancement technology Note 10
- Note 11 Advanced Sieclear spatial compounding
- Note 14 eSie™ Touch elasticity imaging / FTI
- Note 16 Custom Tissue Imaging
D.A.R
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093812
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) - OLD
{16}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use: 10V4 Phased Array Transducer for use with ACUSON 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 | | 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 | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 3,4 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K081148, K090334
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi view spatial compounding Note 3
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
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) Concurrence of CDRH, Office of Device Evaluation (ODE) ()
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K093812
{17}------------------------------------------------
510 (k) Number (if known):
Device Name:
i
Indications For Use:
14L5 SP Linear Array Transducer for use with ACUSON S2000 Diagnostic 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) |…
