(46 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its functions does not mention any AI or ML capabilities.
No.
The device is described as a diagnostic ultrasound imaging system, intended for creating images and providing measurements for clinical diagnosis, not for treating any condition.
Yes.
The "Device Description" explicitly states that the ultrasound systems are "diagnostic ultrasound systems."
No
The device description explicitly states it is a "software controlled diagnostic ultrasound system" and describes hardware components like transducers (implied by the imaging modes and applications), a flat panel display, and the Acuson Acunav Ultrasound Catheter. While software is a key component, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an ultrasound imaging system. It uses sound waves to create images of internal anatomical structures.
- Intended Use: The intended uses listed are all related to imaging and visualization of internal anatomy and measuring anatomical structures. While the measurements and calculations can be used adjunctively with other medical data for diagnosis, the device itself is not analyzing biological specimens.
- No Specimen Analysis: There is no mention of the device analyzing any type of biological sample.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The 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, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Product codes
IYN, IYO, ITX, OBJ
Device Description
The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, heart, great vessel anatomy
Indicated Patient Age Range
Adult and pediatric patients.
Intended User / Care Setting
Physician / 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)
Nonclinical tests were submitted covering acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. The system complies with specified voluntary safety standards. Testing was performed to verify the software release. No clinical data was required as the device and predicate use the same technology and principles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2016
Siemens Medical Solutions, Inc. Ultrasound Division % Mr. Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K152369
Trade/Device Name: Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: September 18, 2015 Received: September 22, 2015
Dear Mr. Job:
This letter corrects our substantially equivalent letter of October 6, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Jeff Balyuo
For Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152369
Device Name S1000, S2000, S3000 Diagnostic Ultrasound Systems
Indications for Use (Describe)
The 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, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Transducer Indications for Use are on the attached pages.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510 (k) Number (if known): Device Name: Intended Use:
K152369 ACUSON S1000, S2000, S3000 Ultrasound System Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation Color Color Amplitude Combined Other CWD Clinical Application A B M PWD Velocitv Doppler Doppler (Specify) (Specify) Imaging Ophthalmic P P P P P P Note 2,3,4,5,7,8,10, Fetal BMDC 11, 13 P P P P b b Note 2,3,4,5,7,8,10, Abdominal BMDC 11, 13, 16, 18 Intraoperative P P P P P P Note 2,3,4,5,7,8,10, BMDC (Note 9) 11, 14 Intraoperative Neurological P P P P P P Note 2,3,4,5,7,8,10, Pediatric BMDC 11 Small Organ P P P P P P Note 2,3,4,5,7,8,10, BMDC (Note 1) 11,14, 16, 18 Neonatal Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,10 Adult Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,10 P P P P P P Note BMDC Cardiac 2,3,4,5,6,7,8,10,15 P P P P P P Trans-esophageal BMDC Note 4 P P P P P Note 2,3,4,5,7,8,10, BMDC Transrectal 11,14 P P P P P Note 2,3,4,5,7,8,10, BMDC Transvaginal 11 Transurethral Intravascular P P P P P Note2,3,4,5,6,7,8,10, P Peripheral vessel BMDC 11.14.15 Laparoscopic P P P P P Note 2,3,4,5,7,8,10, Musculo-skeletal P BMDC Conventional 11,14, 18 P P P P P P Note 2,3,4,5,7,8,10, Musculo-skeletal BMDC Superficial 11.14. 18 Other (specify) P P P P P P BMDC Note 3,4,6, 10 Neonatal Cardiac
N = new indication; P = previously cleared by FDA K142876 Additional Comments:
Note 1 i.e. breast, testes, thyroid, penis, prostate, etc. Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 For example: vascular, abdominal
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 16 Custom Tissue Imaging
Note 18 VTI
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
- Note 13 STIC
- Note 15 AHP
- Note 17 eSie Fusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
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| 510 (k) Number (if known): | K152369 |
|---|---|
| Device Name: | 12L4 Transducer for use with ACUSON S1000, S2000 and S3000 |
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 | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11, 14, 16 | |||||||||||
| Small Organ | |||||||||||
| (Note 1) | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||||
| 11, 14, 16 | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5, 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 K142876 Additional Comments:
i.e.: breast, testes, thyroid, penis, prostate, etc. Note 1
SieClear multi-view spatial compounding Note 3
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
compounding/DTCE
Note 14 eSie™ Touch elasticity imaging
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial
Note 16 Custom Tissue Imaging /FTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
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510 (k) Number (if known): Device Name:
K152369 CW2 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| 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 K142876
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
For example: vascular, abdominal Note 9
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6
510 (k) Number (if known): Device Name:
K152369
CW5 Probe For Use On ACUSON S1000, S2000, S3000 Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | P | ||||||||||
| Abdominal | P | ||||||||||
| Intraoperative | |||||||||||
| (Note 9) | P | ||||||||||
| Intraoperative | |||||||||||
| Neurological | P | ||||||||||
| 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 K142876 Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. abdominal
Note 9 For example: vascular,
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7
510 (k) Number (if known): Device Name:
K152369 ______________________________________________________________________________________________________________________________________________________________________
EC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound System
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | |||||
| 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 2,3,4,5,6,,7,8,10, | |||
| 11, | |||||||||||
| Intraoperative | |||||||||||
| 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 | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | |||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Trans-esophageal | |||||||||||
| Transrectal | P | P | P | P | P | P | BMDC | Note 2,3,4,5, 6, 7,8,10, | |||
| 11,14 | |||||||||||
| Transvaginal | P | 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 K142876 Additional Comments:
Note 1 i.e .: breast, testes, thyroid, penis, prostate, etc.
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 14 eSie™ Touch elasticity imaging / FTI
- Note 2 Ensemble tissue harmonic imaging
Tissue Equalization Technology Note 4
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
8
510 (k) Number (if known): Device Name:
K152369 MC9-4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, 11 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,6,,7,8,10, | ||
| 11, | ||||||||||
| Intraoperative | ||||||||||
| Note 9 | ||||||||||
| 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 | P | 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 | P | BMDC | Note 2,3,4,5, 6, 7,8,10, | ||
| 11,14 | ||||||||||
| Transvaginal | P | 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 K142876 Additional Comments:
Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
9
510 (k) Number (if known): Device Name:
9L4 Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Abdominal | |||||||||||
| Intraoperative | |||||||||||
| Note 9 | |||||||||||
| 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 | ||||
| 2,3,4,5,6,7,8,10, | |||||||||||
| 11,14, 16, 18 | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||||
| 11 | |||||||||||
| Adult Cephalic | P | P | P | P | P | ||||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | ||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,6, | ||||
| 7,8,10, 11, 14,15 | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | P | P | P | P | P | BMDC | Note | ||||
| 2,3,4,5,6,7,8,10, 11, | |||||||||||
| 14 | |||||||||||
| Musculo-skeletal | |||||||||||
| 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 K142876 Additional Comments:
- Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
- Note 3 SieClear multi-view spatial compounding
- Note 5 3-Scape real-time 3D imaging
- Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular - Note 9 Abdomen and Vascular
- Note 11 Advanced Sieclear spatial compounding
- Note 15 AHP
- Note 18 VTI (Virtual Touch Imaging)
Note 2 Ensemble tissue harmonic imaging
- Note 4 Tissue Equalization Technology
- Note 6 Cadence contrast agent imaging
- Note 8 Power SieScape panoramic imaging
- Note 10Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI Note 16Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
10
510 (k) Number (if known): Device Name:
K152369 14L5 Multi-D Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Note 9 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11, 14, 16 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,6, | |||
| 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 K142876 Additional Comments:
Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 9 Abdomen and Vascular Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 eSie™ Touch elasticity imaging / FTI Note 16 Custom Tissue Imaging Note 18 Virtual Touch Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
11
510 (k) Number (if known): Device Name:
K152369 4P1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | 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 | ||||||||||
| Note 9 | ||||||||||
| 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 K142876 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 9 Abdomen and Vascular
Note 10Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
12
510 (k) Number (if known): Device Name:
6C2 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | 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, 14, 16, 17 | ||||||||||
| Intraoperative | ||||||||||
| Note 9 | ||||||||||
| 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 K142876 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 7 B&W SieScape panoramic imaging
Note 3 SieClear multi-view spatial compounding Note 5 3-Scape real-time 3D imaging
Note 8 Power SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 9. Power GreCscape panoramic imc
Note 10. Clarify VE vascular enhancement
Note 10 Clarify VE vascular enhancement technology Note 14 eSie™ Touch elasticity imaging / FTI
Note 11 Advanced Sieclear spatial compounding
Note 16Custom Tissue Imaging
Note 17 eSie Fusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
13
510 (k) Number (if known): Device Name:
K152369 4C1 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
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 | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8, 10,
11, 14, 16, 17, 18 |
| Intraoperative
Note 9 | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | P | P | P | P | P | P | P | | BMDC | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K142876 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology compounding
- Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial
Note 16 Custom Tissue Imaging
Note 18 VTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
Note 14 eSie™ Touch elasticity imaging / FTI Note 17 eSie Fusion
14
510 (k) Number (if known): Device Name:
K152369 K152369 6C1HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems
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 | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |
| 11 | ||||||||||
| Abdominal | P | P | P | P | P | P | P | BMDC | Note2,3,4,5,6,7,8, | |
| 10, 11, 14, 16, 17, | ||||||||||
| 18 | ||||||||||
| Intraoperative | ||||||||||
| Note 9 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | P | P | BMDC | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | BMDC | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | BMDC | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K142876 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imagin
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology compounding
Note 14 eSie™ Touch elasticity imaging / FTI
Note 17 eSie Fusion
Note 16Custom Tissue Imaging Note 18 VTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Note 3 SieClear multi-view spatial compounding
Note 7 B&W SieScape panoramic imaging
Note 9 Abdomen and Vascular
Note 11 Advanced Sieclear spatial
15
510 (k) Number (if known): Device Name:
K152369 8C3HD Curved Array Transducer For Use On ACUSON S2000, S3000 Ultrasound Systems
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 | 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, 14, 16 | ||||||||||
| Intraoperative | ||||||||||
| Note 9 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | ||
| 11 | ||||||||||
| Small Organ | P | P | P | P | P | P | BMDC | |||
| 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 K142876 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding
Note 16Custom Tissue Imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
- Note 14 eSie™ Touch elasticity imaging / FTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
16
510 (k) Number (if known): K152369 Device Name:
4V1 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
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 | 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, | ||
| 14, 16, 17 | ||||||||||
| Intraoperative | ||||||||||
| 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 K40959 Additional Comments:
Note 2 Ensemble tissue harmonic imaging Note 4 Tissue Equalization Technology
Note 3 SieClear multi view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging Note 11 Advanced Sieclear spatial
Note 10Clarify VE vascular enhancement technology compounding
Note 14 eSie™ Touch elasticity imaging / FTI Note 16Custom Tissue Imaging
Note 17 eSie Fusion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
17
510 (k) Number (if known): ___ Device Name:
K152369 10V4 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Abdominal | P | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| 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# 140959 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
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
18
510 (k) Number (if known): ____K152369 Device Name:
14L5 SP Linear Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Indications For Use:
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 | |||
| 2,3,4,5,7,8,10,11 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14, 16 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note2,3,4,5,6 | |||
| ,7,8,10, 11,14,15 | ||||||||||
| 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# 140959 Additional Comments:
Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 7 B&W SieScape panoramic imaging
Note 9 For example: vascular, abdominal technology
Note 11 Advanced Sieclear spatial compounding Note 15 AHP
Note 4 Tissue Equalization Technology Note 6 Cadence contrast agent imaging Note 8 Power SieScape panoramic imaging Note 10Clarify VE vascular enhancement
Note 14 eSie™ Touch elasticity imaging / FTI Note 16Custom Tissue Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
19
K152369 510 (k) Number (if known):
7CF2 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
Device Name:
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 | ||||||||||
| 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# 140959 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
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 13 STIC
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20
510 (k) Number (if known):
K152369 7CF1 Curved array mechanical 3D transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation Color Amplitude Color Combined Other PWD CWD Clinical Application B M A Velocity (Specify) Doppler Doppler (Specify) Imaging Ophthalmic P P P P P Note 2,3,4,5,7,8,10, Fetal BMDC 11,13 P P P P P Note 2,3,4,5,7,8,10, Abdominal BMDC 11, 13 Intraoperative Intraoperative Neurological Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaqinal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional Musculo-skeletal Superficial Other (specify)
N = new indication; P = previously cleared by FDA K# 140959 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
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 13 STIC
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
21
510 (k) Number (if known): Device Name:
K152369 9EVF4 Curved Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
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, 13 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| 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# 140959 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
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 13 STIC
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
22
510 (k) Number (if known): Device Name:
K152369 V5Ms Multiplane TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | P | P | P | P | P | P | BMDC | Note 4 | ||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K# 140959
Additional Comments:
Note 4 Tissue Equalization Technology
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23
510 (k) Number (if known): __ K152369 Device Name: 18L6 HD Linear Array Transducer For Use On ACUSON S1000, S2000,
S3000 Ultrasound Systems
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Note 1) | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14, 16 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 15 | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2,3,4,5,7,8,10, | |||
| 11,14,15 | ||||||||||
| 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 K081148, K090334, K093812, K111674, K121138
Additional Comments:
Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 7 B&W SieScape panoramic imaging Note 10Clarify VE vascular enhancement technology
Note 8 Power SieScape panoramic imaging
Note 11 Advanced Sieclear spatial compounding Note 15 AHP
- Note 14 eSie™ Touch elasticity imaging Note 16 Custom Tissue Imaging/FTI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
24
510 (k) Number (if known): Device Name:
K152369 8V3 Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
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 | P | BMDC | Note 2,3,4,5,7,8,10 | ||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| 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 3,4,6 | ||
| 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 | BMDC | Note 3,4,6 |
N = new indication; P = previously cleared by FDA K# 140959
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
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
25
510 (k) Number (if known): Device Name:
K152369 4V1c Phased Array Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | 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 | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| Intraoperative | ||||||||||
| Neurological | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| Pediatric | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| Cardiac | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| 15 | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 | ||
| 15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | ||||||||||
| Neonatal Cardiac | P | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10 |
N = new indication; P = previously cleared by FDA K#'s 140959 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
Cadence contrast agent imaging Note 6
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
Note 15 AHP
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
26
510 (k) Number (if known): Device Name:
K152369 6L3 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| Note 9 | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 1 | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 15 | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 15 | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | P | P | P | P | P | BMDC | Note 2 3 4 5 7 8 10, | |||
| 11 | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K#'s140959 Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 6 Cadence contrast agent imaging
Note 8 Power SieScape panoramic imaging
Note 3 SieClear multi-view spatial compounding
Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging
Note 10Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear spatial compounding
Note 15 AHP
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
27
510 (k) Number (if known): Device Name:
K152369 EV-8C4 Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | 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 | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | P | BMDC | Note 2 3 4 5 6 7 8 | ||
| 10 | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA K#'s 140959 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 10Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
28
510 (k) Number (if known): Device Name:
K152369 V7M TEE Transducer For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
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 | Power | ||||||||||
| (Amplitude) | |||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (Specify) * | Harmonic | ||||||||||
| Imaging | Other | ||||||||||
| (Specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | P | P | P | P | P | P | P | P | Note 4 | ||
| Intraoperative | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | Note 4 | ||
| Small Organ | |||||||||||
| (specify)** | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | Note 4 | ||
| Trans-esophageal | P | P | P | P | P | P | P | P | Note 4 | ||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| (Conventional) | |||||||||||
| Musculo-skeletal | |||||||||||
| (Superficial) | |||||||||||
| Other (specify) |
P=previously cleared by the FDA under premarket notifications #K142876 Additional Comments:
- Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
Note 2 Ensemble tissue harmonic imaging
Note 4 Tissue Equalization Technology
Note 10Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
29
| 510 (k) Number (if known): | K152369 |
|---|---|
| Device Name: | AcuNav 8F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems |
| Intended Use: | The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiolo |
ogy as well as visualization of other devices in the heart of adult and pediatric patients.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) * | Other: | |||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Vascular) | ||||||||||
| Intraoperative | ||||||||||
| (Neurological) | ||||||||||
| Pediatric | P | P | P | P | P | P | P | P | ||
| Small Organ | ||||||||||
| (Specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | P | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | P | P | P | P | P | P | P | P | ||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P | P |
P=previously cleared by the FDA K142876
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
30
510 (k) Number (if known): Device Name:
K152369
AcuNav 10F Ultrasound Catheter For Use On ACUSON S1000, S2000, S3000 Ultrasound Systems
Intended Use:
The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) * | Other: | |||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Vascular) | ||||||||||
| Intraoperative | ||||||||||
| (Neurological) | ||||||||||
| Pediatric | P | P | P | P | P | P | P | |||
| Small Organ | ||||||||||
| (Specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | P | P | P | P | P | P | P | |||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P |
P=Previously cleared by the FDA K142876
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Colo Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED)
31
510(k) Summary
July 15, 2015
| 1. Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043 | | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--|
| Contact Person: | Nancy Burke
Telephone:
Fax: | (425) 295-8665
(425) 391-9161 | |
| 2. Device Name: | Acuson S1000, S2000, S3000™ Diagnostic Ultrasound Systems
May also be marketed as:
ACUSON Oxana 1 Ultrasound System
ACUSON Oxana 2 Ultrasound System
ACUSON Oxana 3 Ultrasound System
ACUSON Oxana 2 Ultrasound Automated Breast Volume Scanner
(ACUSON Oxana 2 ABVS)
ACUSON Ultrasound Automated Breast Volume Scanner
(ACUSON ABVS) | | |
| Common Name: | Diagnostic Ultrasound System | | |
| Classification: | Regulatory Class:
Review Category:
Classification Panel: | II
Tier II
Radiology | |
| | Ultrasonic Pulsed Doppler Imaging System
Product Code 90-IYN | FR # 892.1550 | |
| | Ultrasonic Pulsed Echo Imaging System
Product Code 90-IYO | FR # 892.1560 | |
| | Diagnostic Ultrasound Transducer
Product Code 90-ITX | FR # 892.1570 | |
| | Diagnostic Ultrasound Catheter
Product Code OBJ | FR # 870.1200 | |
| Manufacturing Site: | Siemens Medical Solutions USA, Inc.,
2500 Millbrook Drive, Suite B
Mountain View, California 94043
Buffalo Grove, IL 60089 | | |
The modified Acuson S1000, S2000, S3000 Ultrasound Systems are substantially equivalent to the company's own systems:
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| System | 510(k) |
|---|---|
| S1000 | K142876 |
| S2000 | K142876 |
| S3000 | K142876 |
4. Device Description:
The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The 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.
5. Intended Use
The 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, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav Ultrasound Catheter is intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
6. Summary of Technological Characteristics
The modified Acuson S1000, S2000, S3000 Ultrasound Systems are the same as the company's own previously cleared Acuson S1000, S2000, S3000 Ultrasound Systems (K142876) with regard to both intended use and technological characteristics. Both the subject ultrasound systems and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.
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The VD10A software release contains workflow and user interface improvements, support for Windows 7 Operating System, imaging improvements, bug fixes, serviceability enhancements and new feature licenses for the S-Family products.
| Feature / Characteristic | Acuson
S1000/S2000/S3000
This Submission | Acuson
S1000/S2000/S3000
K# 142876 |
|---------------------------------------------------|------------------------------------------------|------------------------------------------|
| Indications for Use: | | |
| Fetal | √ | √ |
| Abdominal | √ | √ |
| Intraoperative | √ | √ |
| Intraoperative neurological | -- | -- |
| Pediatric | √ | √ |
| Small Organ | √ | √ |
| Neonatal cephalic | √ | √ |
| Adult Cephalic | √ | √ |
| Cardiac | √ | √ |
| Trans-esophageal | √ | √ |
| Transrectal | √ | √ |
| Transvaginal | √ | √ |
| Peripheral vessel | √ | √ |
| Laparoscopic | -- | -- |
| Musculo-skeletal (conventional) | √ | √ |
| Musculo-skeletal (superficial) | √ | √ |
| Center Frequencies Supported: | | |
| 2.0 MHz | √ | √ |
| 3.0 MHz | √ | √ |
| 3.2 MHz | √ | √ |
| 3.3 MHz | √ | √ |
| 4.2 MHz | √ | √ |
| 4.4 MHz | √ | √ |
| 4.8 MHz | √ | √ |
| 5.0 MHz | √ | √ |
| 5.2 MHz | √ | √ |
| 6.0 MHz | √ | √ |
| 6.5 MHz | √ | √ |
| 6.9 MHz | √ | √ |
| 9.5 MHz | √ | √ |
| 10.0 MHz | √ | √ |
| Modes: | | |
| B | √ | √ |
| Parallel processing in B mode | √ | √ |
| M | √ | √ |
| PWD (Pulsed Wave Doppler) | √ | √ |
| CWD (Continuous Wave Doppler) | √ | √ |
| D (Color Doppler) | √ | √ |
| Amplitude Doppler | √ | √ |
| Feature / Characteristic | Acuson
S1000/S2000/S3000
This Submission | Acuson
S1000/S2000/S3000
K# 142876 |
| Features: | | |
| Quad processing in color | √ | √ |
| ■ Native™ tissue harmonic
imaging | √ | √ |
| ■ SieScape™ panoramic
imaging | √ | √ |
| ■ Color SieScape™ panoramic
imaging | √ | √ |
| ■ 3-Scape™ real-time 3D
imaging | √ | √ |
| ■ fourSight™ 4D transducer
technology | √ | √ |
| ■ TEQ™ ultrasound technology | √ | √ |
| ■ Cardiac Imaging
physiological signal display | √ | √ |
| ■ syngo® Auto OB
measurements | √ | √ |
| ■ Advanced SieClear™ spatial
compounding | √ | √ |
| ■ STIC (Fetal Heart Imaging) | √ | √ |
| ■ Amnioscopic rendering | √ | √ |
| ■ Cadence contrast agent
imaging | √ | √ |
| ■ Clarify™ vascular
enhancement technology | √ | √ |
| ■ eSie™ Touch elasticity imaging | √ | √ |
| ■ syngo® Auto Left heart | √ | √ |
| ■ syngo® Velocity Vector
Imaging | √ | √ |
| ■ Semi Auto-segmentation (eSie
Calc) | √ | √ |
| ■ Custom Tissue Imaging /
Speed of Sound | √ | √ |
| ■ AHP | √ | √ |
| ■ eSie Fusion (S3000 only) | √ | √ |
| ■ VTI (S2000 & S3000 only) | √ | √ |
| Wireless | √ | √ |
| Monitor: 21" FPD | √ | √ |
| Output Display Standard (Track 3) | √ | √ |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 |
| UL 60601-1 Certified | √ | √ |
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7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- 트 AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
- 트 ISO 10993-1 Biocompatibility
Cleared patient contact materials, electrical and mechanical safety are unchanged. Testing was performed to verify the software release.
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical data is not required.
9. Summary
Intended uses and other key features are consistent with traditional clinical practice and FDA quidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the S1000, S2000 and S3000 systems are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.