(43 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and measurement capabilities. There is no mention of AI, ML, or any related terms, nor is there any description of training or test data sets which would be expected for an AI/ML device. The image processing mentioned is typical for ultrasound systems and does not necessarily indicate AI/ML.
No
The device is described as a diagnostic ultrasound imaging system, used for clinical diagnosis, not for treating diseases or conditions.
Yes
The 'Intended Use / Indications for Use' section states that "The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes." Additionally, the 'Device Description' section describes it as a "software controlled diagnostic ultrasound system." The 'Predicate Device(s)' also explicitly name 'Diagnostic Ultrasound System'.
No
The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound system" and mentions acquiring and displaying ultrasound echo data, which inherently requires hardware components (transducer, processing unit, display) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the system is for ultrasound imaging of various anatomical structures and for providing information used for clinical diagnosis purposes. This involves imaging the body directly, not analyzing samples taken from the body.
- Device Description: The description details a diagnostic ultrasound system that acquires and displays ultrasound echo data. This is a form of in vivo (within the living body) imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.
Therefore, the S2000 ultrasound imaging system is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The S2000 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system aiso provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
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, transrectal, transvaginal, peripheral vessel, musculo-skeletal (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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYC, 90-ITX
Device Description
The Acuson S2000™ Ultrasound System is a new 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, 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, Intraoperative Neurological, Trans-esophageal, Transrectal, Transvaginal, Peripheral vessel, Neonatal Cardiac
Indicated Patient Age Range
Neonatal/Adult Cephalic (appears to cover neonates/pediatric to adult, based on additional contexts for associated transducers)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
NOV 1 3 2007
510(K) SUMMARY
S2000 Diagnostic Ultrasound system
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
1. Submitted By:
Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, CA 94043
Contact Person:
Shelly Pearce Requlatory Affairs
Phone: (650) 694-5988 FAX: (650) 943-7053
Date Prepared:
September 4, 2007
2. Proprietary Name:
Acuson S2000™ Diagnostic Ultrasound System
Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
Classification Name:
| 21 CFR 892.1550 | ||
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYC |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
3. Predicate Device:
K063803, 11/22/2006, Acuson Antares Diagnostic Ultrasound System K063085, 11/14/2006, Acuson Sequoia Diagnostic Ultrasound System K032620, 10/10/2003, GE Voluson 730 Ultrasound System
4. Device Description:
The Acuson S2000™ Ultrasound System is a new 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, 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.
The S2000, has been designed to meet the following product safety standards:
- . UL 60601-1, Safety Requirements for Medical Equipment
- . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic 트 Output Indices on Diagnostic Ultrasound Equipment
- 트 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
1
- 93/42/EEC Medical Devices Directive 를
- 트 Safety and EMC Requirements for Medical Equipment
- EN 60601-1 트
- 이 EN 60601-1-1
- EN 60601-1-2
- . EN 60601-2-37
- 트 IEC 61157 Declaration of Acoustic Power
- ISO 10993 Biocompatibility 트
ട. Intended Uses:
The S2000 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system aiso provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Technological Comparison to Predicate Device: 6.
The S2000 is substantially equivalent to the Acuson Antares, cleared via K063803, the Acuson Sequoia, cleared via K063085, and the GE Voluson, cleared via K032620. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
End of 510(k) Summary
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines representing the body, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the figure. The text is in all caps and is smaller than the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2007
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072786
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: September 29, 2007 Received: October 1, 2007
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 Probe CW5 Probe 9EC4 Curved Array 9L4 Linear Array 14L5 Multi-D Array
4P1 Phased Array 6C2 Curved Array 4C1 Curved Array 4V1 Phased Array 10V4 Phased Array
3
| 14L5 SP Linear Array | V5Ms Multiplane TEE |
|---|---|
| 7CF2 Curved Array | 17L5HDS Linear Array |
| 9EVF4 Curved Array | 8V3 Phased Array |
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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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
4
Page 2 – Mr. Job
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Vonn M. Whing
Nancy C. Brogdon ਨਾ Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
Siemens Medical Solutions USA, Inc. Ultrasound Division
Page 1 of 1
510(k) Number (if known): K072786
Device Name:
Acuson 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, transrectal, transvaginal, peripheral vessel, musculo-skeletal (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.
Prescription Use __ XX_ (Part 21 CFR 801 Subpart D) 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)
thry M. Why
(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
6
ACUSON S2000™ Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: ACUSON S2000 Ultrasound System
Ultrasound imaging or iluid 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 | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11, 13 | |
| Abdominal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11, 13 | |
| Intraoperative | ||||||||||
| (Note 9) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11, 14 | |
| Intraoperative | ||||||||||
| Neurological | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11, 14 | |
| Pediatric | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Small Organ | ||||||||||
| (Note 1) | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Neonatal Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10 | |
| Adult Cephalic | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10 | |
| Cardiac | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,6,7,8,10 | |
| Trans-esophageal | N | N | N | N | N | N | N | BMDC | ||
| Transrectal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Transvaginal | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | N | BMDC | Note2,3,4,5,6,7,8,10, 11,14 | |
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Musculo-skeletal | ||||||||||
| Superficial | N | N | N | N | N | N | N | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Other (specify) | N | N | N | N | N | N | N | BMDC | Note 3,4,6 |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
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
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 9 For example: vascular, abdominal
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compouriding
. 4. 1. 1
- STIC Note 13
Note 14 eSie™ Touch elasticity imaging/FTI
Lorine Mintez
(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 801.10 Diagnostic Ultrasound Indications for Use Form
7
ACUSON S2000™ Diagnostic Ultrasound System
510(k) Submission
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | |||||||||
| Abdominal | P | |||||||||
| Intraoperative | ||||||||||
| (Note 9) | P | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ | ||||||||||
| (Note 1) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Trans esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | |||||||||
| Musculo-skeletal | ||||||||||
| Superficial | P | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803; E = added under Appendix E
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)
Prescription Use (Per 21 CFR 801.109)
Amai Th. Wh
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
.
8
510 (k) Number (if known):
Device Name:
CW5 Probe for use with ACUSON S2000
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | |||||||||
| Abdominal | P | |||||||||
| Intraoperative | ||||||||||
| (Note 9) | P | |||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ | ||||||||||
| (Note 1) | P | |||||||||
| Neonatal Cephalic | P | |||||||||
| Adult Cephalic | P | |||||||||
| Cardiac | P | |||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | |||||||||
| Musculo-skeletal | ||||||||||
| Superficial | P | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803; E = added under Appendix E
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)
Prescription Use (Per 21 CFR 801.109)
Lori Khan
(Division Sign Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
9
ACUSON S2000" Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use:
9EC4 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 2,3,4,5,7,8,10,
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; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
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
- B&W SieScape panoramic imaging Note 7
- Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
- Advanced Sieclear multi-view spatial compounding Note 11
eSie™ Touch elasticity imaging/FTI Note 14
Aymm Whay
(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)
10
ACUSON S2000™ Diagnostic Ultrasound System
510(k) Submission
510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Devicc Name: Intended Use:
9L4 Linear 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 | ||||
| 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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11 | ||||||||||
| 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, | |||
| 11 | ||||||||||
| 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, | |||
| 11, 14 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 14 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 14 | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
Additional Comments:
-
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging -
Note 3 SieClear multi-view spatial compounding
-
Tissue Equalization Technology Note 4
-
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
-
Note 11 Advanced Sieclear multi-view spatial compounding
-
eSie™ Touch elasticity imaging/FTI Note 14
fruch why
(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)
11
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| 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 | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,6, | |||
| 7,8,10, 11, 14 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 14 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Ensemble tissue harmonic imaging Note 2
- Note 3 SieClear multi-view spatial compounding
- Tissue Equalization Technology Note 4
- 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
- Clarify VE vascular enhancement technology Note 10
- Note 11 Advanced Sieclear multi-view spatial compounding
. 1
- Note 14 eSie™ Touch elasticity imaging/FTI
loun M. Whz
(Division Sign-Off)
(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)
12
510(k) Submission
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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (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 | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| 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 | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
- Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Power SieScape panoramic imaging Note 8
Note 10 Clarify VE vascular enhancement technology
.
(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)
Aonald M. Whiz
(DIV Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
. .
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding Note 3
Tissue Equalization Technology Note 4
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
Advanced Sieclear multi-view spatial compounding Note 11
Arith Wh
(Division Sian-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)
:
14
510 (k) Number (if known):
Device Name: Intended Use: 4C1 Curved Array Transducer for use with ACUSON S2000
Ultrasound imaging or fuid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Note2,3,4,5,6,7,8, | |||
| 10, 11 | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- Note 4 Tissue Equalization Technology
- Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging
- Note 7 B&W SieScape panoramic imaging
- Note 8 Power SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear multi-view spatial compounding
(Division Sign-Off)
Division of Reproductive, Abdominal an Radiologic 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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 | ||||
| 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 | |||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
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
- B&W SieScape panoramic imaging Note 7
- Note 8 Power SieScape panoramic imaging
- Note 10 Clarify VE vascular enhancement technology
- Note 11 Advanced Sieclear multi-view spatial compounding
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number KD72786
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| 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 | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
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 Note 10 Clarify VE vascular enhancement technology
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K073278
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
17
510 (k) Number (if known):
Device Name:
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Note 9) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |||
| Intraoperative | ||||||||||
| Neurological | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11 | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note2,3,4,5,6 | |||
| ,7,8,10, 11,14 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
ਕ
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
- Tissue Equalization Technology Note 4
- 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 9 For example: vascular, abdominal
- Note 10 Clarify VE vascular enhancement technology
- Advanced Sieclear multi-view spatial compounding Note 11
- Note 14 eSie™ Touch elasticity imaging/FTI
(Division Sign-Off)
eproductive, Abdominal and Radiologic 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
18
ACUSON S2000" Diagnostic Ultrasound System 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
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:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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, | ||||
| 11,13 | |||||||||||
| Abdominal | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11, 13 | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803; E = added under Appendix E
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 7
- B&W SieScape panoramic imaging Note 8
- Power SieScape panoramic imaging Note 10
- Clarify VE vascular enhancement technology Note 11 Advanced Sieclear multi-view spatial compounding
- Note 13 STIC
Loui K. Whig
(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)
19
510 (k) Number (if known):
Device Name: Intended Use: 9EVF4 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 | ||||
| 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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8, | |||
| 10,11 | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| 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; E = added under Appendix E
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 7 B&W SieScape panoramic imaging
-
Power SieScape panoramic imaging Note 8
-
Note 10 Clarify VE vascular enhancement technology
-
Note 11 Advanced Sieclear multi-view spatial compounding
Lory 2. Why
(Division Sign-Off)
vision 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)
20
510 (k) Number (if known):
Device Name: Intended Use:
V5Ms Multiplane TEE 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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | P | P | P | P | P | P | BMDC | |||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063803; E = added under Appendix E
Additional Comments: n/a
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
tony h. Whx
Division of Reproductive. Abdominal a Radiological Devices 510(k) Number
21
KC72786
ACUSON S2000" Diagnostic Ultrasound Syste 510(k) Submission
Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
Intended Use:
17L5HDS Linear 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 | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14 | |||||||||||
| 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, | |||
| 11,14 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14 | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14 | |||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
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
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compounding
Note 14 eSie™ Touch elasticity imaging/FT1
loyne K. Witz
oductive. Abdominal and Divisio Radiolo 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
22
510 (k) Number (if known):
Device Name:
Intended Use:
8V3 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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | |
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | 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 | P | BMDC | Note 2,3,4,5,7,8,10 | |
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | BMDC | Note 3,4,6 | |
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | ||||||||||
| Neonatal Cardiac | P | P | P | P | P | P | P | BMDC | Note 3,4,6 |
N = new indication; P = previously cleared by FDA K# 063085; E = added under Appendix E
Additional Comments:
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
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
Division Sign-Off
ductive. Abdorninal 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)