ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K090334 |
|---|---|
| Device Name | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medi Cal Solutions, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Feb 20, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
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, 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 Imagino".
Device Story
Acuson S2000 is a diagnostic ultrasound system for imaging and fluid flow analysis. It processes acoustic signals from various transducers (curved, linear, phased array, TEE) to produce real-time 2D, M-mode, Doppler (PWD, CWD, Color, Amplitude), and 3D images. Used in clinical settings (e.g., OR, clinic) by physicians and sonographers. Includes calculation packages for anatomical measurements and the Arterial Health Package (AHP) for Intima Media Thickness (IMT) measurement. AHP allows comparison against normative tables to assist in cardiovascular risk communication. Output is displayed for clinician review to support diagnosis. Benefits include non-invasive visualization and quantitative assessment of anatomical structures and vascular health.
Clinical Evidence
Bench testing only. System safety and performance verified against standards including UL 60601-1, IEC 60601-2-37, and AIUM/NEMA UD-2/UD-3. AHP software validated against peer-reviewed normative tables.
Technological Characteristics
Diagnostic ultrasound system using pulsed echo and Doppler imaging. Transducers: curved, linear, phased array, TEE. Connectivity: standard ultrasound interfaces. Software: includes measurement and calculation packages (AHP). Biocompatibility: ISO 10993-1. Safety: IEC 60601-1, IEC 60601-2-37.
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 ultrasound imaging and fluid flow analysis in patients of all ages.
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
Related Devices
- K093812 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Mar 3, 2010
- K111674 — ACUSON · Siemens Medical Solutions USA, Inc. · Jun 30, 2011
- K112596 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc., Ultrasound DI · Sep 16, 2011
- K142876 — ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems · Siemens Medical Solutions USA, Inc. · Oct 23, 2014
- K090276 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM · Siemens Medical Solutions USA, Inc. · Feb 19, 2009
Submission Summary (Full Text)
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IC0{0334
S2000 Ultrasound System 510(k) Submission
## 510(k) Summarv Prepared February 3, 2009
FEB 2 0 2009 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
Submission Date: February 3, 2009
Device Name: Acuson S2000™ Diagnostic Ultrasound System
Common Name: Diagnostic Ultrasound System
## Classification:
Regulatory Class: 11 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 90-1YO 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:
- UL 60601-1, Safety Requirements for Medical Equipment ■
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards 1
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment 해
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical 를 Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUMNEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound 내
- 트 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment 파
- EN/IEC 60601-1 내
- EN/IEC 60601-1-1
- EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power 체
- ISO 10993-1 Biocompatibility 비
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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, 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 Imagino".
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
.
Public Health Service
FEB 2 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solution USA, Inc., Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K090334 . .
Trade/Device Name: ACUSON S2000m 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 9, 2009 Received: February 10, 2009
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, buting of devices, good manifacturing 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 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Array
4P1 Phased Array 6C2 Curved Array 4C1 Curved Array 4V1 Phased Array 10V4 Phased Array
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Enclosure(s)
14L5 SP Linear Array 7CF2 Curved Array 9EVF4 Curved Array V 5Ms Multiplane TEE 17L5HDS Linear Array 18L6 HD Linear Array 8V3 Phased Array 4V1c Phased Array 613 EV8C4
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 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); 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this totterspiesses contact that an (240) 276-3566: ·
Sincerely yours,
Heelt Lewen
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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#### 1.3 Indications for Use
510(k) Number (if known):
K090334
Device Name: S2000™Diagnostic Ultrasound System
Indications for Use: K090334
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 cephalio, 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".
Prescription Use (Part 21 CFR 801 Subpart.D) AND/OR
Over-The-Counter Use (21 CER 801 Subpart C)
(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 Reproductive, Abdominal and
Radiological Devices
510(k) Number K090334
S2000 510(k) Submission
Page 12 of 46
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## S2000 Ultrasound System 510(k) Submission
## 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:
| | 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 2,3,4,5,7,8,10,<br>11, 13 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Intraoperative<br>(Note 9) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Intraoperative<br>Neurological | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Small Organ<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,6,7,8,10,15 |
| Trans-esophageal | P | P | P | P | P | P | P | | BMDC | |
| 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 | 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 | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Other (specify)<br>Neonatal Cardiac | P | P | P | P | P | P | P | | BMDC | Note 3,4,6 |
N = new indication; P = previously cleared by FDA, K072786
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
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
- Note 9 For example: vascular, abdominal Note 10
Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding
- Note 13 STIC
- eSie™ Touch elasticity imaging Note 14
etc. Note 15 AHP
(Division Sign-Off)
Division
Division of Reproductive, Abdominal and
Reproductive, Abdominal and
Radiological Devices
510(k) No.
510(k) Number
K010334
S2000 510(k) Submission
Page 18 of 1326
. W
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## S2000 Ultrasound System 510(k) Submission
#### (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:
14.73
| | 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) | | | | | | | | | | | |
Nia such indication; P = 5 rowlously gleared by FDA ill 088803, KO72785
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 Device Evaluation (ODE)
Hula Levin
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090334
S2000 510(k) Submission
Page 19 of 1326
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## Diagnostic Ultrasound Indications for Use Form
#### 510 (k) Number (if known):
Device Name: Intended Use:
## CW5 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
Additionshomments:
· Forexample: breast, testes, thyroid, panis, prostate, 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)
---
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 20 of 1326
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#### Diagnostic Ultrasound Indications for Use Form
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:
| | 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, K072788
Accitional Comments:
: Note 'i' For example: breast, testes, thyreigl, gents, prostate, atc
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
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Advanced Sieclear spatial compounding Note 11
eSie™ Touch elasticity imaging Note 14
(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) | |
|---------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal and, Radiological Devices | |
| 510(k) Number | K090334 |
| S2000 510(k) Submission | Page 16 of 46 |
|-------------------------|---------------|
| Page 21 of 1326 | |
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## Diagnostic Ultrasound Indications for Use Form
్లో ప్రా
510 (k) Number (if known): ·
Device Name: Intended Use:
9L4 Linear Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|--------------------------------------|
| | 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 | | | | | | | | | | |
| 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 |
| Neonatal. Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | | 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
Additional Commento:
For example: breast, testes, thyrold, panis, prostate, Note - i . -
- 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 6 Cadence contrast agent imaging
- Note 7 B&W SieScape panoramic imaging
- Power SieScape panoramic imaging Note B
- Clarify VE vascular enhancement technology Note 10
- Note 11 Advanced Sieclear spatial compounding
- Not
Not
| ote 14 | eSie™ Touch elasticity imaging |
|--------|--------------------------------|
| ote 15 | AHP |
(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)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
K 90324
510(k) Number
S2000 510(k) Submission
Page 22 of 1326
Page 17 of 46
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
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:
| | | | | | | | 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 | |
| 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
Actificital Coginants:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Ensemble tissue harmonic imaging Note 2
- 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
- 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
- eSie™ Touch elasticity imaging Note 14
-
Halstein
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
(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)
S2000 510(k) Submission
Page 23 of 1326
{11}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
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
Additional Comments:
Ensemble tiesus hamonia imaging NOVER 2
Note. 3 SieClear mult - tew spatiat compounding
Tissua Equalization Technology Note. J. ..
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
B&W SieScape panoramic imaging Note 7
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
(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
(Division' Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number < 0
S2000 510(k) Submission
Page 24 of 1326
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
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 | | 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 |
| 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 claared by FDA K# 063085, K072733
Additional Comments:
- 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 7 B&W SieScape panoramic imaging
- Note 8 Power SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Advanced Sieclear spatial compounding Note 11
eSie™ Touch elasticity imaging Note 14
Hestem
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
(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)
S2000 510(k) Submission
Page 25 of 1326
{13}------------------------------------------------
( . . . . .
#### Diagnostic Ultrasound Indications for Use Form
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 Color Color Amplitude Combined Other Clinical Application B PWD A M CWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P P Note 2,3,4,5,7,8,10, Fetal BMDC 11 P P P b P P Note2,3,4,5,6,7,8, Abdominal BMDC 10, 11, 14 intraoperative . -Abdominal Intraoperative 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 Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by FDA K# 063085, K072786, K032114
Additional Comments:
Ensemble tissue harmonic imaging Note 2
Nota 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
B&W SieScape panoramic imaging Note 7
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
(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) | (Division Sign-Off) |
|--------------------------------------------------------------|---------------------|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K090334 |
S2000 510(k) Submission Page 26 of 1326
Page 21 of 46
{14}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
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 |
| 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
Additional Comments:
t
Note 2 Ensemble tissue harmonic imagina
Note 3 SieClear multi view spatial compounding
Tissue Equalization Technology Note 4
3-Scape real-time 3D imaging Note 5
B&W SieScape panoramic imaging Note 7
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
Advanced Sieclear spatial compounding Note 11
Note 14 eSie™ Touch elasticity imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
S2000 510(k) Submission
Page 27 of 1326
{15}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
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<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Nord 3 SieClear multi view spetial compounding
Noté 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Nota 7
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
S2000 510(k) Submission
Page 28 of 1326
{16}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Indications For Use: 1 4L5 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) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Note 9) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative<br>Neurological | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | | BMDC | Note 15 |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note2,3,4,5,6<br>,7,8,10, 11,14,15 |
| 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, K072
Additional Commondes: s
- Note T Forvexample: breast, hestes, thyroid, penis, prostate,
- 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
- Power SieScape panoramic imaging Note 8
- For example: vascular, abdominal Note 9
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear spatial compounding
- eSie™ Touch elasticity imaging Note 14
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AND THE RACK IS NEEDED) Concurrence of CDRH, Office of Device Evaluation CODE
(Division Sign-Off)
Prescription Use (Per 21 CFR 80) Dillistion of Reproductive, Ab-
Radiological Devices
510(k) Number
S2000 510(k) Submission
Page 29 of 1326
Page 24 of 46
Note 15 AHP
Note 15 AHF
{17}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
## Siemens Medical Solutions, Inc. Ultrasound Division
510 (k) Number (if known):
Device Name: Intended Use: 7CF2 Curved array mechanical 3D transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | Other<br>(Specify) | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|---------------------------|--------------------|--------------------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color Velocity<br>Imaging | | Combined<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,13 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| 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 | | | | | | | | | |…
